Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorHarvard Medical School (HMS and HSDM)
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Starmatrix collagen membrane
- Autogenous gingival graft
Treatment groups
12 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov