Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT03199118
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2017-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Use of Platelet Rich Fibrin in Addition to CAF and SCTG for Treatment of Gingival Recession
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'srhelbanna@gmail.com', 'phone': '+201000760002', 'title': 'Sarah Elbanna, assistant lecturer at the Oral Medicine and Periodontology department', 'organization': 'Cairo University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months from the surgical procedure', 'description': 'mortality, severe bleeding', 'eventGroups': [{'id': 'EG000', 'title': 'CAF+SCTG+PRF', 'description': 'Intervention: surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane\n\nPatients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CAF+SCTG', 'description': 'Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recession Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: CAF+SCTG+PRF', 'description': 'Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane\n\nPatients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)'}, {'id': 'OG001', 'title': 'Control Group:CAF+SCTG', 'description': 'Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline-3 months-6 months', 'description': 'measured from the cemento-enamel junction to the margin of the gingiva at the mid-buccal point of the teeth at basline, 3 months and 6 months. It is recorded in millimeters (mm) with lower values mean better outcome.', 'unitOfMeasure': 'length in millimeters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recession Width', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAF+SCTG+PRF', 'description': 'Intervention: surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane\n\nPatients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)'}, {'id': 'OG001', 'title': 'CAF+SCTG', 'description': 'Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline-3 months-6 months', 'description': 'It was measured as the distance from mesial and distal papillae along the CEJ. It is recorded in millimeters (mm) where lower values means a better outcome.', 'unitOfMeasure': 'length in millimeters (mm)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Root Coverage Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAF+SCTG+PRF', 'description': 'Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane\n\nPatients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)'}, {'id': 'OG001', 'title': 'CAF+SCTG', 'description': 'Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession'}], 'classes': [{'categories': [{'measurements': [{'value': '92.9', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '91.6', 'spread': '17.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': '(preoperative vertical recession - postoperative vertical recession/preoperative vertical recession) x 100.', 'unitOfMeasure': 'percentage of root coverage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Probing Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAF+SCTG+PRF', 'description': 'Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane\n\nPatients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)'}, {'id': 'OG001', 'title': 'CAF+SCTG', 'description': 'Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '1.71', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline-3 months-6 months', 'description': 'measured from the gingival margin to the base of the pocket probe at the midbuccal point of the teeth. Its is recorded in millimeters (mm) where lower values mean better outcome.', 'unitOfMeasure': 'length in millimeters(mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Attachment Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAF+SCTG+PRF', 'description': 'Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane\n\nPatients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)'}, {'id': 'OG001', 'title': 'CAF+SCTG', 'description': 'Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '3.79', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '4', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '2.14', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '2', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline-3 months-6 months', 'description': 'measured from the CEJ to the base of the sulcus at the midbuccal point of the teeth. Its is recorded in millimeters (mm).', 'unitOfMeasure': 'length in millimeters(mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gingival Biotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAF+SCTG+PRF', 'description': 'Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane\n\nPatients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)'}, {'id': 'OG001', 'title': 'CAF+SCTG', 'description': 'Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline-3 months-6 months', 'description': 'under local anesthesia from 3 mm below the gingival margin trans-gingivally piercing tissues horizontally, perpendicular to the long axis of the tooth until it contacts bone. Its is recorded in millimeters (mm) where higher values mean better outcome.', 'unitOfMeasure': 'length in millimeters(mm)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Width of Keratinized Gingiva', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAF+SCTG+PRF', 'description': 'Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane\n\nPatients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)'}, {'id': 'OG001', 'title': 'CAF+SCTG', 'description': 'Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '2.36', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '2.64', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '3.64', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '3.71', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '3.86', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '4.14', 'spread': '0.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline-3 months-6 months', 'description': 'from the margin of the gingiva to the mucogingival junction at the midbuccal point of the teeth. Its is reported in millimeters where higher values mean better outcome.', 'unitOfMeasure': 'length in millimeters(mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAF+SCTG+PRF', 'description': 'The patients suffering from class I or II gingival recession in the intervention group will receive a subepithelial connective tissue graft (SCTG) covered by platelet rich fibrin membrane (PRF) followed by a coronally advanced flap (CAF)\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession\n\nplatelet rich fibrin: in addition to coronally advanced flap and sub-epithelial connective tissue graft, PRF is also used in the surgical procedure to cover gingival recession'}, {'id': 'OG001', 'title': 'CAF+SCTG', 'description': 'Control group patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG only\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '64.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'questionnaire given to the patient 6 months after the surgery', 'description': 'printed yes/ no questionnaire with 3 questions:\n\n1. would you do this surgery again?\n2. would you recommend this treatment to others?\n3. are you satisfied with the results?', 'unitOfMeasure': 'percentage of patients satisfied', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Root Coverage Esthetic Score (RES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAF+SCTG+PRF', 'description': 'Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane\n\nPatients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)'}, {'id': 'OG001', 'title': 'CAF+SCTG', 'description': 'Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession'}], 'classes': [{'categories': [{'measurements': [{'value': '9.43', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '9.29', 'spread': '1.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The RES system evaluates 5 variables 6 months after surgery: Zero, 3, or 6 points are used for the evaluation of the position of the gingival margin (GM). A score of 0 or 1 point is used for each of the following variables: marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction (MGJ) alignment, and gingival color (GC). the points are then summed up to obtain one figure representing the RES.\n\nminimum value:0 maximum value: 10 which means better outcome for RES', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post Operative Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAF+SCTG+PRF', 'description': 'Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane\n\nPatients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)'}, {'id': 'OG001', 'title': 'CAF+SCTG', 'description': 'Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after 2 weeks from surgery', 'description': "Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worstpain imaginable') for the first 2 weeks postoperatively", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CAF+SCTG+PRF', 'description': 'Intervention: surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane\n\nPatients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)'}, {'id': 'FG001', 'title': 'CAF+SCTG', 'description': 'Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '6 months follow-up', 'groupId': 'FG000', 'numSubjects': '14'}, {'comment': '6 months follow-up', 'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were selected from the outpatient clinic,Faculty of Dentistry, Cairo University between 30/09/2017 and 1/08/ 2019 Patients \\>18 Periodontally and systemically healthy Miller class I or II buccal recession defects Presence of identifiable CEJ Clinical indication and/or patient request for recession coverage.', 'preAssignmentDetails': '5 patients were excluded for not meeting inclusion criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CAF+SCTG+PRF', 'description': 'Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane\n\nPatients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)'}, {'id': 'BG001', 'title': 'CAF+SCTG', 'description': 'Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)\n\nCAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'white non hispanic', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Egypt', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-30', 'size': 1176840, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-22T12:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-22', 'studyFirstSubmitDate': '2017-06-21', 'resultsFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2017-06-22', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-22', 'studyFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recession Depth', 'timeFrame': 'baseline-3 months-6 months', 'description': 'measured from the cemento-enamel junction to the margin of the gingiva at the mid-buccal point of the teeth at basline, 3 months and 6 months. It is recorded in millimeters (mm) with lower values mean better outcome.'}], 'secondaryOutcomes': [{'measure': 'Recession Width', 'timeFrame': 'baseline-3 months-6 months', 'description': 'It was measured as the distance from mesial and distal papillae along the CEJ. It is recorded in millimeters (mm) where lower values means a better outcome.'}, {'measure': 'Root Coverage Gain', 'timeFrame': 'at 6 months', 'description': '(preoperative vertical recession - postoperative vertical recession/preoperative vertical recession) x 100.'}, {'measure': 'Probing Depth', 'timeFrame': 'baseline-3 months-6 months', 'description': 'measured from the gingival margin to the base of the pocket probe at the midbuccal point of the teeth. Its is recorded in millimeters (mm) where lower values mean better outcome.'}, {'measure': 'Clinical Attachment Level', 'timeFrame': 'baseline-3 months-6 months', 'description': 'measured from the CEJ to the base of the sulcus at the midbuccal point of the teeth. Its is recorded in millimeters (mm).'}, {'measure': 'Gingival Biotype', 'timeFrame': 'baseline-3 months-6 months', 'description': 'under local anesthesia from 3 mm below the gingival margin trans-gingivally piercing tissues horizontally, perpendicular to the long axis of the tooth until it contacts bone. Its is recorded in millimeters (mm) where higher values mean better outcome.'}, {'measure': 'Width of Keratinized Gingiva', 'timeFrame': 'baseline-3 months-6 months', 'description': 'from the margin of the gingiva to the mucogingival junction at the midbuccal point of the teeth. Its is reported in millimeters where higher values mean better outcome.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'questionnaire given to the patient 6 months after the surgery', 'description': 'printed yes/ no questionnaire with 3 questions:\n\n1. would you do this surgery again?\n2. would you recommend this treatment to others?\n3. are you satisfied with the results?'}, {'measure': 'Root Coverage Esthetic Score (RES)', 'timeFrame': '6 months', 'description': 'The RES system evaluates 5 variables 6 months after surgery: Zero, 3, or 6 points are used for the evaluation of the position of the gingival margin (GM). A score of 0 or 1 point is used for each of the following variables: marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction (MGJ) alignment, and gingival color (GC). the points are then summed up to obtain one figure representing the RES.\n\nminimum value:0 maximum value: 10 which means better outcome for RES'}, {'measure': 'Post Operative Pain', 'timeFrame': 'after 2 weeks from surgery', 'description': "Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worstpain imaginable') for the first 2 weeks postoperatively"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['root coverage'], 'conditions': ['Gingival Recession']}, 'referencesModule': {'references': [{'pmid': '12516830', 'type': 'BACKGROUND', 'citation': 'Berlucchi I, Francetti L, Del Fabbro M, Testori T, Weinstein RL. Enamel matrix proteins (Emdogain) in combination with coronally advanced flap or subepithelial connective tissue graft in the treatment of shallow gingival recessions. Int J Periodontics Restorative Dent. 2002 Dec;22(6):583-93.'}, {'pmid': '7928129', 'type': 'BACKGROUND', 'citation': 'Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.'}, {'pmid': '12516826', 'type': 'BACKGROUND', 'citation': 'Gonshor A. Technique for producing platelet-rich plasma and platelet concentrate: background and process. Int J Periodontics Restorative Dent. 2002 Dec;22(6):547-57.'}, {'pmid': '26177630', 'type': 'BACKGROUND', 'citation': 'Keceli HG, Kamak G, Erdemir EO, Evginer MS, Dolgun A. The Adjunctive Effect of Platelet-Rich Fibrin to Connective Tissue Graft in the Treatment of Buccal Recession Defects: Results of a Randomized, Parallel-Group Controlled Trial. J Periodontol. 2015 Nov;86(11):1221-30. doi: 10.1902/jop.2015.150015. Epub 2015 Jul 16.'}, {'pmid': '9638695', 'type': 'BACKGROUND', 'citation': 'Marx RE, Carlson ER, Eichstaedt RM, Schimmele SR, Strauss JE, Georgeff KR. Platelet-rich plasma: Growth factor enhancement for bone grafts. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Jun;85(6):638-46. doi: 10.1016/s1079-2104(98)90029-4.'}, {'pmid': '7928128', 'type': 'BACKGROUND', 'citation': 'Michaelides PL, Wilson SG. An autogenous gingival graft technique. Int J Periodontics Restorative Dent. 1994 Apr;14(2):112-25.'}, {'pmid': '12886996', 'type': 'BACKGROUND', 'citation': 'Okuda K, Kawase T, Momose M, Murata M, Saito Y, Suzuki H, Wolff LF, Yoshie H. Platelet-rich plasma contains high levels of platelet-derived growth factor and transforming growth factor-beta and modulates the proliferation of periodontally related cells in vitro. J Periodontol. 2003 Jun;74(6):849-57. doi: 10.1902/jop.2003.74.6.849.'}, {'pmid': '12479634', 'type': 'BACKGROUND', 'citation': "Paolantonio M, Dolci M, Esposito P, D'Archivio D, Lisanti L, Di Luccio A, Perinetti G. Subpedicle acellular dermal matrix graft and autogenous connective tissue graft in the treatment of gingival recessions: a comparative 1-year clinical study. J Periodontol. 2002 Nov;73(11):1299-307. doi: 10.1902/jop.2002.73.11.1299."}, {'pmid': '11993379', 'type': 'BACKGROUND', 'citation': 'Petrungaro P. Platelet-rich plasma for dental implants and soft-tissue grafting. Interview by Arun K. Garg. Dent Implantol Update. 2001 Jun;12(6):41-6. No abstract available.'}, {'pmid': '10505810', 'type': 'BACKGROUND', 'citation': 'Pini-Prato G, Baldi C, Pagliaro U, Nieri M, Saletta D, Rotundo R, Cortellini P. Coronally advanced flap procedure for root coverage. Treatment of root surface: root planning versus polishing. J Periodontol. 1999 Sep;70(9):1064-76. doi: 10.1902/jop.1999.70.9.1064.'}, {'pmid': '12787218', 'type': 'BACKGROUND', 'citation': 'Roccuzzo M, Bunino M, Needleman I, Sanz M. Periodontal plastic surgery for treatment of localized gingival recessions: a systematic review. J Clin Periodontol. 2002;29 Suppl 3:178-94; discussion 195-6. doi: 10.1034/j.1600-051x.29.s3.11.x.'}, {'pmid': '14611717', 'type': 'BACKGROUND', 'citation': 'Tozum TF, Demiralp B. Platelet-rich plasma: a promising innovation in dentistry. J Can Dent Assoc. 2003 Nov;69(10):664.'}, {'pmid': '8877664', 'type': 'BACKGROUND', 'citation': 'Wennstrom JL, Zucchelli G. Increased gingival dimensions. A significant factor for successful outcome of root coverage procedures? A 2-year prospective clinical study. J Clin Periodontol. 1996 Aug;23(8):770-7. doi: 10.1111/j.1600-051x.1996.tb00608.x.'}, {'pmid': '9526912', 'type': 'BACKGROUND', 'citation': 'Zucchelli G, Clauser C, De Sanctis M, Calandriello M. Mucogingival versus guided tissue regeneration procedures in the treatment of deep recession type defects. J Periodontol. 1998 Feb;69(2):138-45. doi: 10.1902/jop.1998.69.2.138.'}]}, 'descriptionModule': {'briefSummary': 'This research will be conducted in an attempt to achieve complete root coverage with physiologic probing depth and a harmonious view with the adjacent tissues using Platelet rich fibrin in conjunction with Coronally advanced flap and subepithelial connective tissue graft.', 'detailedDescription': 'The study population will be divided into 2 groups:\n\nGroup 1:\n\nPatients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft. The patients should be non-smoker, medically free and above 18 years\n\nGroup 2:\n\nPatients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft and platelet rich fibrin. the patients should meet the same inclusion criteria mentionned above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 1) Patients 18 years and older 2) Buccal recession defects classified as either Miller class I or II gingival recession.\n\n3\\) Clinical indication and/or patient request for recession coverage 4) Good oral hygiene\n\nExclusion Criteria:\n\n\\- 1) Miller Class III and IV gingival recession. 2) Any systemic diseases or any medication. 3) Pregnancy. 4) Patients undergoing radiotherapy. 5) Handicapped and mentally retarded patients. 6) Current and former smokers as smoking is a contra-indication for plastic periodontal surgery .\n\n7\\) Teeth with cervical restorations, abrasion'}, 'identificationModule': {'nctId': 'NCT03199118', 'briefTitle': 'Use of Platelet Rich Fibrin in Addition to CAF and SCTG for Treatment of Gingival Recession', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Use of Coronally Advanced Flap and Subepithelial Connective Tissue Graft With or Without Platelet Rich Fibrin in the Treatment of Miller Class I or II Gingival Recession: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'sarahelbanna84'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAF+SCTG+PRF', 'description': 'The patients suffering from class I or II gingival recession in the intervention group will receive a subepithelial connective tissue graft (SCTG) covered by platelet rich fibrin membrane (PRF) followed by a coronally advanced flap (CAF)', 'interventionNames': ['Procedure: CAF +SCTG', 'Other: platelet rich fibrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CAF+SCTG', 'description': 'Control group patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG only', 'interventionNames': ['Procedure: CAF +SCTG']}], 'interventions': [{'name': 'CAF +SCTG', 'type': 'PROCEDURE', 'otherNames': ['CTG'], 'description': 'the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession', 'armGroupLabels': ['CAF+SCTG', 'CAF+SCTG+PRF']}, {'name': 'platelet rich fibrin', 'type': 'OTHER', 'otherNames': ['PRF'], 'description': 'in addition to coronally advanced flap and sub-epithelial connective tissue graft, PRF is also used in the surgical procedure to cover gingival recession', 'armGroupLabels': ['CAF+SCTG+PRF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Azza Ezzelarab', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of periodontics, Faculty of dentistry, Cairo university'}, {'name': 'Noha Ghallab', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of periodontics, Faculty of dentistry, Cairo university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer in the oral medicine and periodontology department', 'investigatorFullName': 'Sarah Elbanna', 'investigatorAffiliation': 'Cairo University'}}}}