Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT

Recruiting now · Not applicable

Conditions studied: Lack of Keratinized Gingiva, Mucogingival Deformity - Insufficient Keratinized Tissue

In brief

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.

Key facts

Study ID

NCT07440303

Run by

Harvard Medical School (HMS and HSDM)

People needed

12

Starts

2025-11-06

Expected to finish

2026-10-01

Last updated by the study team

2026-02-27

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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)

Where it is running

• Harvard Dental Center — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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