RecruitingNot ApplicableNCT07440303

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


Sponsor

Harvard Medical School (HMS and HSDM)

Enrollment

12 participants

Start Date

Nov 6, 2025

Study Type

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

Min Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Autogenous gingival graft and a medical device called Starmatrix collagen membrane for people with lack of keratinized gingiva and mucogingival deformity - insufficient keratinized tissue. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEStarmatrix collagen membrane

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.

OTHERAutogenous gingival graft

gingival insufficiency will be treated with autogenous gingival graft


Locations(1)

Harvard Dental Center

Boston, Massachusetts, United States

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NCT07440303


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