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)
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.
Description
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. Since 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, of…
Eligibility
- Age range
- 20–80 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Criteria: * 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 s…
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
Location
- Harvard Dental CenterBoston, Massachusetts