Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 12:38 AM
Study NCT ID:
NCT07130266
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2025-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive 0.8% Hyaluronic Acid Gel in Open-Flap Surgery for Thin Gingival Phenotype in Patients With Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'During the surgery session, patients were block randomized, with the allocation order using a computer program (www.randomizer.org.). Group assignment was carried out by another investigator who was not involved in the treatment procedure or clinical measurements (UGE). Study groups were as follows:\n\n1. OFD + 0.8% HA gel (n = 20, test group)\n2. OFD alone (n = 20, control group).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical attachment level (CAL)', 'timeFrame': 'Baseline - 3months - 6 months', 'description': 'CAL were measured from both the buccal and palatal/lingual aspects of each tooth at six points including mesial, distal, and midpoint, and recorded in mm. CAL was measured as the distance between the base of the pocket and the enamel cement junction.'}], 'secondaryOutcomes': [{'measure': '3D Measurements', 'timeFrame': 'Baseline - 3months - 6 months', 'description': 'The median tooth in the area of three adjacent teeth undergoing surgery was chosen for analysis, as it included the interproximal papilla regions of the adjacent teeth treated with periodontal surgery. Data from the 3rd and 6th months intraoral digital scans were extracted separately from the baseline, and the region for volumetric analysis was divided into three equal parts: mesial, distal, and middle. The interproximal and middle regions were evaluated separately, and the volumetric changes over time were calculated in mm³ using the program.'}, {'measure': 'Analysis of 2D Gingival Thickness Changes', 'timeFrame': 'Baseline - 3months - 6 months', 'description': 'The change in gingival thickness at all time points was calculated using standard reference points on the previously superimposed models. Gingival thickness change was measured in 2D at these points, and repeated for both buccal and palatal/lingual regions.'}, {'measure': 'Relative gingival recession (rGR)', 'timeFrame': 'Baseline - 3months - 6 months', 'description': 'The distance between the horizontal reference point on the acrylic stent and the marginal gingiva at the surgical site was measured and recorded as relative gingival recession (rGR).'}, {'measure': 'Probing depth (PD)', 'timeFrame': 'Baseline - 3months - 6 months', 'description': 'Defined as the distance from the base of the periodontal pocket to the marginal gingiva'}, {'measure': 'Plaque (P)', 'timeFrame': 'Baseline - 3months - 6 months', 'description': 'presence of plaque (P) was evaluated as present/absent at six points of each tooth and recorded as percentages. Surgical site measurements were repeated at 3-and 6 months.'}, {'measure': 'Bleeding on probing (BoP)', 'timeFrame': 'Baseline - 3months - 6 months', 'description': 'Bleeding on probing (BoP) was evaluated as present/absent at six points of each tooth and recorded as percentages. Surgical site measurements were repeated at 3-and 6 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyaluronic acid', 'Periodontitis', 'Open Flap Debridement', 'Gingival recession'], 'conditions': ['Hyaluronic Acid', 'Open Flap Debridement', 'Periodontitis', 'Gingival Phenotype', 'Gingival Recession']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the clinical effectiveness of 0.8% hyaluronic acid (HA) gel as an adjunct to open flap debridement (OFD) in periodontitis patients with a thin gingival phenotype.\n\nThe primary research question is:\n\nDoes the adjunctive use of 0.8% HA gel reduce gingival recession and improve clinical parameters? To answer this, researchers will compare the adjunctive use of 0.8% HA gel to physiological saline in combination with OFD, assessing their effects on clinical outcomes and gingival recession in patients with a thin gingival phenotype.\n\nParticipants will:\n\n* Receive 0.8% HA gel application during OFD surgery and a second application at 4 weeks postoperatively.\n* Attend follow-up visits at 1, 3, and 6 months after surgery for clinical assessments and measurements.', 'detailedDescription': 'A total of 40 patients were enrolled in the study and randomly assigned to two groups: (a) OFD + 0.8% HA gel (n = 20, test group) and (b) OFD alone (n = 20, control group). Clinical parameters including plaque (P), bleeding on probing (BoP), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded at baseline. Following initial periodontal therapy, sites with PPD ≥ 5 mm and horizontal bone loss, were identified in patients with a thin gingival phenotype, determined using color-coded gingival probes. Intraoral digital scans were taken, and relative gingival recession (rGR) was recorded immediately before surgery.\n\nDuring OFD, the test group received adjunctive 0.8% HA gel, while the control group received physiological saline. In the test group, HA gel application was repeated at 4 weeks postoperatively. Changes in soft tissue volume (mm³) and thickness (mm) were measured using specialized computer software. Follow-up evaluations were performed at 3 and 6 months post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of periodontitis (Stage II/III);\n2. Presence of horizontal bone loss with at least three adjacent teeth, each exhibiting a probing depth ≥ 5mm and a keratinized tissue width ≥ 2mm on single-rooted teeth;\n3. a thin gingival phenotype;\n4. Areas with horizontal bone loss without intra-bony defects, where no additional hard and soft tissue augmentation was required\n5. a full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS \\<20%.\n\nExclusion Criteria:\n\n* Systemic diseases\n* Smokers\n* Pregnant or lactating women\n* Those who received periodontal treatment within the last 6 months'}, 'identificationModule': {'nctId': 'NCT07130266', 'briefTitle': 'Adjunctive 0.8% Hyaluronic Acid Gel in Open-Flap Surgery for Thin Gingival Phenotype in Patients With Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Evaluation of the Clinical and Volumetric Effectiveness of 0.8% Hyaluronic Acid Gel Adjunct to Open-Flap Surgery in Periodontitis Patients With Thin Gingival Phenotype', 'orgStudyIdInfo': {'id': 'E.69156'}, 'secondaryIdInfos': [{'id': '20220801', 'type': 'OTHER_GRANT', 'domain': 'Bezmialem Vakif University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Open Flap Debridement (OFD)', 'description': 'Open flap debridement was carried out, and the surgical site was irrigated with physiological saline in a manner consistent with the HA gel application protocol in the test group. A second application of physiological saline to the sulcus area was performed four weeks postoperatively', 'interventionNames': ['Procedure: giving an impression of the application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open Flap Debridement (OFD)+HA', 'description': 'Open flap debridement was carried out, and 1 ml of 0.8% HA gel was applied to the root surfaces of the affected teeth, bone, and the inner surface of the flap in the surgical area for 2 minutes. HA gel application was repeated at four weeks postoperatively.', 'interventionNames': ['Procedure: Procedure/Surgery: Hyaluronic acid gel application']}], 'interventions': [{'name': 'Procedure/Surgery: Hyaluronic acid gel application', 'type': 'PROCEDURE', 'description': 'After root surface cleaning and infected cement removal, 0.8% HA gel was applied to the root surface, bone, and inner surface of the flap and left for 2 minutes.', 'armGroupLabels': ['Open Flap Debridement (OFD)+HA']}, {'name': 'giving an impression of the application', 'type': 'PROCEDURE', 'description': 'In the control group, instead of HA gel, the area was irrigated with physiological saline solution.', 'armGroupLabels': ['Open Flap Debridement (OFD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakif University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Sadiye Gunpinar, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem Vakif University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Following the article publication of study protocol in a journal.', 'ipdSharing': 'YES', 'description': 'Study protocol and statistical analysis plan.', 'accessCriteria': 'The required data can be shared by responsible person (principal investigator of the study) upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}