Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT
The Clinical Efficacy of Star Matrix Versus Autogenous Gingival Graft in Augmenting Keratinized Tissue Around Teeth- A Split-mouth Randomized Controlled Clinical Trial
Harvard Medical School (HMS and HSDM)
12 participants
Nov 6, 2025
INTERVENTIONAL
Conditions
Summary
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. Central 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? Primary objectives Compare the 6-month increase in keratinized tissue width between Star Matrix and autogenous graft sites. Assess patient-reported pain and morbidity associated with each treatment. Secondary objectives Measure operative time, early healing scores, esthetic outcomes, and (optional) histologic quality of the regenerated tissue. Methods 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.
Eligibility
Inclusion Criteria4
- Adults 20 - 80 years old who need gingival augmentation on both sides of the lower jaw.
- Able and willing to sign the consent form, follow study instructions and return for all visits
- Generally healthy (no significant illnesses or medicines that could interfere with healing).
- Demonstrates good daily oral hygiene (low plaque levels at baseline).
Exclusion Criteria13
- Does not meet any of the inclusion points or is unlikely to follow the schedule
- Previous gingival graft at the study site that failed
- Needs a root-coverage (recession-repair) procedure instead of simple width augmentation
- Active, untreated gum disease, cavities, infection, or chronic inflammation near the study teeth
- Used cigarettes, e-cigarettes, or other nicotine products within 3 weeks
- Insulin-dependent diabetes or hemoglobin A1c \> 6.5 %
- Cancer (other than minor skin cancers or in-situ cervical cancer) within the past 5 years
- Currently pregnant or breastfeeding
- Taking (or soon to begin) drugs that change bone turnover (e.g., bisphosphonates, steroids)
- Diseases that disturb bone metabolism (except common osteoporosis)
- Auto-immune disease or known allergy to porcine collagen or study materials
- Active infection at the planned graft site
- 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)
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
gingival insufficiency will be treated with autogenous gingival graft
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07440303