Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:20 AM
Study NCT ID:
NCT07440303
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized split-mouth study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'increase in keratinized-tissue width', 'timeFrame': '6 months', 'description': 'pre- and post-operative width of keratinized gingiva in the treated area will be measured and compared'}], 'secondaryOutcomes': [{'measure': 'pain level', 'timeFrame': '7 days', 'description': "p't will be given a scale of 0-10 for pain experienced during the first week after procedure"}, {'measure': 'color matching', 'timeFrame': '6 months', 'description': 'standardized photographs will be used to evaluate gingival color'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['mucogingival deformity'], 'conditions': ['Lack of Keratinized Gingiva', 'Mucogingival Deformity - Insufficient Keratinized Tissue']}, 'descriptionModule': {'briefSummary': 'This split-mouth randomized controlled clinical trial will test whether a ready-to-use collagen membrane (Star Matrix) can widen the protective band of gum tissue (keratinized gingiva) as effectively as the standard free gingival graft harvested from the palate.\n\nCentral question Can Star Matrix provide the same or better gain in keratinized tissue width-with less patient discomfort and chair-time-than an autogenous graft?\n\nPrimary objectives\n\nCompare the 6-month increase in keratinized tissue width between Star Matrix and autogenous graft sites.\n\nAssess patient-reported pain and morbidity associated with each treatment.\n\nSecondary objectives\n\nMeasure operative time, early healing scores, esthetic outcomes, and (optional) histologic quality of the regenerated tissue.\n\nMethods Twelve adults with ≤ 2 mm keratinized tissue on contralateral lower-jaw teeth will be enrolled. Each participant receives Star Matrix on one side and a conventional free gingival graft on the other. Follow-up visits at 2, 4, 8, 12 and 24 weeks include clinical measurements, standardized photographs, and a 7-day postoperative pain diary. An optional 2 mm punch biopsy at 6 months is analyzed microscopically.', 'detailedDescription': 'Healthy gums include a "band" of firm, pink tissue (keratinized gingiva) that helps people brush comfortably and protects the area where the tooth meets the bone. Studies suggest that when this band is narrower than about 2 mm, plaque control becomes harder and the risk of recession rises; in one maintenance study, nearly one-fifth of such sites lost further tissue over time.\n\nSince the 1960s the standard way to widen this band has been a free gingival graft-moving a strip of the patient\'s own palatal tissue to the thin area. The technique works, but it also creates a second surgical wound, offers only a limited amount of donor tissue, causes notable postoperative pain, and the graft can look or feel different from nearby gum.\n\nResearchers have explored substitutes such as preserved sclera, freeze-dried skin, and acellular dermal matrix, yet none has matched the predictability of a patient-derived graft. For example, acellular dermal matrix shrank by about 71 percent and often healed as scar-like tissue with inflammatory reactions.\n\nStar Matrix is a new cross-linked collagen membrane made from highly purified porcine type I collagen. It combines a smooth outer coating that shields the wound with a porous inner layer that welcomes cell ingrowth and is placed porous side down to encourage the patient\'s own cells to replace it over time. Because it is supplied sterile and ready-to-use, Star Matrix eliminates the donor-site injury and could shorten surgery. However, its effectiveness has never been directly compared with the current gold-standard graft in a controlled clinical trial-providing the rationale for the present study.\n\nOur study will test a new, ready-to-use collagen membrane called Star Matrix as an alternative for the conventional surgery that takes a strip of a patient\'s own tissue from the roof of the mouth (an autogenous gingival graft) to augment thin or missing gum. We will enroll twelve adult patients who need gum thickening on both sides of their lower jaw; each person will receive Star Matrix on one side and their own tissue on the opposite side, so every patient acts as their own control. Our goals are:\n\n1. Primary aim - gingival augmentation\n\n o Find out whether Star Matrix can widen the firm, protective gum (keratinized gum tissue) around teeth by at least the same amount as the patient-derived tissue six months after surgery.\n2. Comfort aim - early healing experience\n\n o Compare how much pain patients feel during the first week after each procedure, using a simple daily pain scale (0 = no pain, 10 = worst possible pain).\n3. Appearance aim - color and texture match\n\n o Judge how well the new gum created by each method blends in with nearby gum (color and surface feel) six months after surgery, using standardized photographs and a validated rating sheet.\n4. Efficiency aim - surgery time\n\n o Record and compare the time the periodontist needs to complete each type of procedure, to see if Star Matrix shortens time in the chair for patients and clinicians.\n5. Exploratory aim - tissue quality (optional) o In volunteers who give permission, collect a very small gum sample (2x2 mm2) at six months to look under the microscope and describe how Star Matrix has been replaced by the patient\'s own tissue.\n\nThese aims will show whether Star Matrix can provide equal or better gum growth with less pain and surgical time, potentially giving patients a single-site, more comfortable alternative to current care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 20 - 80 years old who need gingival augmentation on both sides of the lower jaw.\n* Able and willing to sign the consent form, follow study instructions and return for all visits\n* Generally healthy (no significant illnesses or medicines that could interfere with healing).\n* Demonstrates good daily oral hygiene (low plaque levels at baseline).\n\nExclusion Criteria:\n\n* Does not meet any of the inclusion points or is unlikely to follow the schedule\n* Previous gingival graft at the study site that failed\n* Needs a root-coverage (recession-repair) procedure instead of simple width augmentation\n* Active, untreated gum disease, cavities, infection, or chronic inflammation near the study teeth\n* Used cigarettes, e-cigarettes, or other nicotine products within 3 weeks\n* Insulin-dependent diabetes or hemoglobin A1c \\> 6.5 %\n* Cancer (other than minor skin cancers or in-situ cervical cancer) within the past 5 years\n* Currently pregnant or breastfeeding\n* Taking (or soon to begin) drugs that change bone turnover (e.g., bisphosphonates, steroids)\n* Diseases that disturb bone metabolism (except common osteoporosis)\n* Auto-immune disease or known allergy to porcine collagen or study materials\n* Active infection at the planned graft site\n* Current use of systemic blood thinners (anticoagulants or antiplatelet agents; e.g., warfarin, heparin/LMWH, DOACs such as apixaban/rivaroxaban/dabigatran/edoxaban, or P2Y12 inhibitors such as clopidogrel/prasugrel/ticagrelor)'}, 'identificationModule': {'nctId': 'NCT07440303', 'briefTitle': 'Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT', 'organization': {'class': 'OTHER', 'fullName': 'Harvard Medical School (HMS and HSDM)'}, 'officialTitle': 'The Clinical Efficacy of Star Matrix Versus Autogenous Gingival Graft in Augmenting Keratinized Tissue Around Teeth- A Split-mouth Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'IRB25-0932'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Autogenous gingival graft/ free gingival graft (FGG)', 'description': 'the area will receive conventional gingival augmentation procedure with use of autogenous gingival graft/ free gingival graft (FGG)', 'interventionNames': ['Other: Autogenous gingival graft']}, {'type': 'EXPERIMENTAL', 'label': 'Starmatrix collagen membrane', 'description': 'the area will receive conventional gingival augmentation procedure with use of Starmatrix collagen membrane', 'interventionNames': ['Device: Starmatrix collagen membrane']}], 'interventions': [{'name': 'Starmatrix collagen membrane', 'type': 'DEVICE', 'description': "Our study will test a new, ready-to-use collagen membrane called Star Matrix as an alternative for the conventional surgery that takes a strip of a patient's own tissue from the roof of the mouth (an autogenous gingival graft) to augment thin or missing gum.", 'armGroupLabels': ['Starmatrix collagen membrane']}, {'name': 'Autogenous gingival graft', 'type': 'OTHER', 'description': 'gingival insufficiency will be treated with autogenous gingival graft', 'armGroupLabels': ['Autogenous gingival graft/ free gingival graft (FGG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Harvard Dental Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'David Kim, DDS, DMSc', 'role': 'CONTACT', 'email': 'dkim@hsdm.harvard.edu', 'phone': '(617) 432-1434'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'David Kim', 'investigatorAffiliation': 'Harvard Medical School (HMS and HSDM)'}}}}