Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT06940050
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing CAF and TCAF With Soft Tissue Grafting for Treating Multiple Recessions in the Premandibula.
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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2037-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2036-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean root coverage', 'timeFrame': 'From enrollment till ten years after surgical treatment.', 'description': 'The average percentage of previously exposed tooth root surface that becomes covered by gingival tissue following a root coverage procedure.'}], 'secondaryOutcomes': [{'measure': 'complete root coverage', 'timeFrame': 'From enrollment till ten years after surgical treatment.', 'description': 'The percentage of teeth for which the previously exposed root surface is completely covered by gingival tissue following the surgical procedure. These teeth show no visible recession after healing.'}, {'measure': 'pocket depth', 'timeFrame': 'From enrollment till ten years after surgical treatment.', 'description': 'The distance from the gingival margin to the bottom of the sulcus measured using a periodontal probe.'}, {'measure': 'recession reduction', 'timeFrame': 'From enrollment till ten years after surgical treatment.', 'description': 'The decrease in the amount of exposed root surface after the root coverage procedure.'}, {'measure': 'width of keratinized tissue', 'timeFrame': 'From enrollment till ten years after surgical treatment.', 'description': 'The distance from the mucogingival junction to the free gingival margin. It includes free and attached gingival tissue, measured with a periodontal probe.'}, {'measure': 'gingival thickness', 'timeFrame': 'From enrollment till ten years after surgical treatment.', 'description': 'Thickness of the gingival tissue measured 1-2 mm apical to the gingival margin.'}, {'measure': 'phenotype', 'timeFrame': 'From enrollment till ten years after surgical treatment.', 'description': 'thin, thick or combined'}, {'measure': 'treatment time', 'timeFrame': 'Only measured during surgery in minutes.', 'description': 'Time in minutes from the first incision till the last suture.'}, {'measure': 'post-operative pain at donor site', 'timeFrame': 'From one week post-operative till three months post-operative.', 'description': 'Post-operative pain at the donor site will be assessed by the patient using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). A higher score indicates greater pain experienced by the patient.'}, {'measure': 'post-operative pain at lower front', 'timeFrame': 'From one week post-operative till three months post-operative.', 'description': 'Post-operative pain at lower front will be assessed by the patient using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). A higher score indicates greater pain experienced by the patient.'}, {'measure': 'number of analgesics', 'timeFrame': 'From one week post-operative till two weeks post-operative.', 'description': 'The number of pain medication tablets consumed by the patient to manage post-operative pain.'}, {'measure': 'score of aesthetic result', 'timeFrame': 'From six months post-operative till ten years post-operative.', 'description': 'Aesthetic satisfaction based on root coverage and color match.'}, {'measure': 'root sensitivity', 'timeFrame': 'From one week pre-operative till ten years post-operative.', 'description': 'Root sensitivity is assessed using the Visual Analogue Scale (VAS), ranging from 0 (no sensitivity) to 10 (extreme sensitivity), based on a tactile test with controlled air flow. A higher score indicates that the patient experiences greater sensitivity.'}, {'measure': 'willingness to retreatment', 'timeFrame': 'From three months post-operative till two years post-operative.', 'description': "A patient's willingness to undergo retreatment based on their previous experience with the procedure. It is assessed by using the Visual Analogue Scale ranging from 0 (not willing at all) to 10 (extremely willing). A patient reporting a higher score indicates greater willingness."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TCAF', 'tunneled coronally advanced flap', 'CAF', 'coronally advanced flap', 'multiple adjacent gingival recessions', 'MAGR', 'premandible'], 'conditions': ['Gingival Recession, Localized', 'Gingival Recession, Plastic Surgery', 'Gingival Recessions', 'Gingival Recession, Mucogingival Surgery']}, 'descriptionModule': {'briefSummary': 'Multiple techniques can be used for recession coverage. The most common techniques are : tunnel technique (T), coronally advanced flap (CAF) or a combination of both (TCAF). Tunnel and coronally advanced flap are frequently used in clinical practice, whereas the combined technique is a rather recent developed surgical approach.\n\nThis randomized controlled trial compares CAF and TCAF to determine which technique provides better root coverage for receding gums in the lower front teeth. The main question it aims to answer is:\n\n\\- What is the average root coverage achieved with each technique in the short and long term?\n\nThis may be clinically relevant because covering gum recession can reduce tooth sensitivity, improve aesthetics and make oral hygiene easier.\n\nResearchers will compare the coronally advanced flap (CAF = the gum is detached and repositioned higher) with the tunneled coronally advanced flap (TCAF = the gum is undermined, only partially detached and repositioned higher). In both techniques, a small piece of tissue is removed from the palate, which is used to cover the recession. The purpose of the connective tissue graft under the flap/tunnel is to increase thickness and provide support.\n\nParticipants will:\n\n* Undergo surgery (CAF or TCAF, randomly assigned) to cover recessions\n* Attend regular check-ups for up to 10 years after surgery\n* Keep a postoperative journal (recording medication use, pain levels, tooth sensitivity, etc.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years old\n* good oral hygiene\n* presence of at least 2 recessions in the premandible\n* good general health\n\nExclusion Criteria:\n\n* smoker\n* pregnant women (assessed at each visit; if the patient appears pregnant during follow-up, x-rays will not be taken)'}, 'identificationModule': {'nctId': 'NCT06940050', 'briefTitle': 'Comparing CAF and TCAF With Soft Tissue Grafting for Treating Multiple Recessions in the Premandibula.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'An RCT Between Coronally Advanced Flap (CAF) and Tunneled Coronally Advanced Flap (TCAF) in Combination With Soft Tissue Graft for Multiple Recession Coverage.', 'orgStudyIdInfo': {'id': 'ONZ-2024-0498'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TCAF + CTG', 'description': 'Tunneled coronally advanced flap with a connective tissue graft', 'interventionNames': ['Procedure: Tunneled coronally advanced flap with a connective tissue graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CAF + CTG', 'description': 'Coronally advanced flap with a connective tissue graft', 'interventionNames': ['Procedure: Coronally advanced flap with a connective tissue graft']}], 'interventions': [{'name': 'Coronally advanced flap with a connective tissue graft', 'type': 'PROCEDURE', 'otherNames': ['CAF + CTG'], 'description': 'The gum at the recession site is detached and reattached higher (combined with a connective tissue graft).', 'armGroupLabels': ['CAF + CTG']}, {'name': 'Tunneled coronally advanced flap with a connective tissue graft', 'type': 'PROCEDURE', 'otherNames': ['TCAF + CTG'], 'description': 'The gum at the recession site is undermined, only partially detached and reattached higher (combined with a connective tissue graft).', 'armGroupLabels': ['TCAF + CTG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Véronique Prof. Dr. Christiaens', 'role': 'CONTACT', 'email': 'vchristi.christiaens@ugent.be', 'phone': '+32 332 40 17'}], 'facility': 'Department of Periodontology and Implantology of Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Véronique Prof. Dr. Christiaens', 'role': 'CONTACT', 'email': 'vchristi.christiaens@ugent.be', 'phone': '+32 332 40 17'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mediplus Ltd UK', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}