Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-03-29 @ 12:14 PM
Study NCT ID:
NCT06646432
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2024-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Gingival Recession With Tunnel Technique Using Connective Tissue Graft and Injectable Platelet Rich Fibrin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recession depth', 'timeFrame': '6 months after the surgery', 'description': 'it will be recorded as the distance between the CEJ and gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.'}, {'measure': 'Keratinized tissue height', 'timeFrame': '6 months', 'description': 'It will be measured from the mucogingival junction to the gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.'}, {'measure': 'Gingival thickness', 'timeFrame': '6 months', 'description': 'It will be measured at a mid-buccal location 1 mm apical to the probing depth level with an spreader. It will be pierced, perpendicularly to the mucosal surface, through the soft tissue with light pressure until a hard surface is felt. The silicone disk stop will then be placed in tight contact with the soft tissue surface. Penetration depth will be measured.'}], 'secondaryOutcomes': [{'measure': 'Post operative pain', 'timeFrame': '10 days', 'description': 'It will be measured by Visual analog Scale (VAS) with records from 0 to 10 with 0 means no pain and 10 means very severe pain. The patient will report the degree he experienced pain and choose a score from VAS.'}, {'measure': 'Recession width', 'timeFrame': '6 months', 'description': 'It will be measured horizontally between the borders of the recession at the level of Cemento-enamel Junction.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tunneling', 'Gingival recession', 'Injectable platelet rich fibrin', 'Minimally invasive periodontology'], 'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'Gingival recession is a common periodontal problem. Consequences include teeth sensitivity, poor esthetics and impaired oral hygiene access. Mild cases are managed by optimizing oral hygiene measures, correction of any causative factor such as faulty tooth brushing, improper dental restoration or denture clasp. Prescription of desensitization products such as specific tooth gels or mouth washes can manage the sensitivity problem. Deeper recession defects need to be addressed by surgical procedures. Coronally advanced flap with connective tissue graft is the gold standard procedure. However, it has some drawbacks due to the need for papillary incisions and vertical incisions in some cases. Within the era of minimally invasive periodontology, tunnel technique with connective tissue graft showed results comparable to coronally advanced flap with connective tissue graft but with some limitations. Addition of another agent may enhance the results of tunnel technique. Injectable platelet rich fibrin is known for its content of growth factors and effects on soft tissue healing. Aim: The study aim is to compare the surgical management of gingival recession with tunnel technique using connective tissue graft and injectable platelet rich fibrin to tunnel with connective graft without injectable platelet rich fibrin.\n\nMethodology: 30 patients with miller class I or II gingival recession will be enrolled. 15 in the test group (Tunnel+ CTG+ i-PRF) and 15 in control group (Tunnel+ CTG). Clinical evaluation at 6 months', 'detailedDescription': '30 patients with miller class I/II gingival recession will be enrolled in this study.\n\n15 patients will be treated using tunnel technique and palatal connective tissue graft inserted and sutured under the prepared tunnel after being soaked in injectable platelet rich fibrin for 15 minutes. The tunnel with the underlying graft will be advanced coronally. (Test Group) The other 15 patients will be treated the same way as in the first group but without soaking the graft in injectable platelet rich fibrin. (Control Group) Clinical parameters will be evaluated at baseline and 6 months follow-up except post-operative pain which will be assessed after 10 days. Histologic examination of small piece of the graft will be done to assess if there is true saturation of growth factors inside the graft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 21 years old\n* Systemically healthy\n* Presence of Miller class I/II gingival recession\n* Presence of identifiable CEJ\n\nExclusion Criteria:\n\n* Smoking\n* Systemic disease that contraindicates surgical procedures.\n* Poor compliance with oral hygiene measures\n* Necrotizing gingival conditions\n* Ongoing active periodontitis'}, 'identificationModule': {'nctId': 'NCT06646432', 'briefTitle': 'Treatment of Gingival Recession With Tunnel Technique Using Connective Tissue Graft and Injectable Platelet Rich Fibrin', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Treatment of Gingival Recession by Tunnel Technique Using Connective Tissue Graft With or Without Injectable Platelet Rich Fibrin: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '486/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group: tunnel with connective tissue graft and injectable platelet rich fibrin', 'description': 'Tunneling will be performed at the recession defect sites with insertion of palatal connective tissue graft taken from the patient hard palate inside the prepared tunnel. The graft will be soaked ,before insertion inside the tunnel, in injectable platelet rich fibrin ,prepared from patient own blood for 15 minutes. The tunnel with the soaked graft inside will be advanced coronally.', 'interventionNames': ['Procedure: Tunnel with connective tissue graft and injectable platelet rich fibrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group: tunnel with connective tissue graft only', 'description': 'Tunnel preparation will be made in the recession defect sites with insertion of palatal connective tissue graft from the patient hard palate. The tunnel with the graft will be advanced coronally.', 'interventionNames': ['Procedure: Tunnel with connective tissue graft only']}], 'interventions': [{'name': 'Tunnel with connective tissue graft and injectable platelet rich fibrin', 'type': 'PROCEDURE', 'description': 'Tunnel with connective tissue graft and injectable platelet rich fibrin', 'armGroupLabels': ['Test group: tunnel with connective tissue graft and injectable platelet rich fibrin']}, {'name': 'Tunnel with connective tissue graft only', 'type': 'PROCEDURE', 'description': 'Tunnel technique with connective tossue graft only without injectable platelet rich fibrin', 'armGroupLabels': ['Control group: tunnel with connective tissue graft only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41522', 'city': 'Ismailia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdelaziz', 'role': 'CONTACT', 'email': 'mohamed_naser@dent.suez.edu.eg', 'phone': '002+ 01118580817'}], 'facility': 'Faculty of dentistry, Suez canal university', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}], 'centralContacts': [{'name': 'Mohammed Abdel-aziz', 'role': 'CONTACT', 'email': 'mohamed_naser@dent.suez.edu.eg', 'phone': '00201118580817'}], 'overallOfficials': [{'name': 'Abdelnasser Elrefaey', 'role': 'STUDY_CHAIR', 'affiliation': 'Suez Canal University'}, {'name': 'Shaimaa Morsy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Suez Canal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suez Canal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}