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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Harvard Medical School (HMS and HSDM)
Study ID
NCT07440303
Status
Recruiting
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Conditions

  • Lack of Keratinized Gingiva
  • Mucogingival Deformity - Insufficient Keratinized Tissue

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Starmatrix collagen membrane — DEVICE
    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.
  • Autogenous gingival graft — OTHER
    gingival insufficiency will be treated with autogenous gingival graft

Study Details

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 Dates

Start date
Nov 6, 2025
Status verified
Feb 2026
Primary completion
May 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Autogenous gingival graft/ free gingival graft (FGG)
    the area will receive conventional gingival augmentation procedure with use of autogenous gingival graft/ free gingival graft (FGG)
  • Experimental: Starmatrix collagen membrane
    the area will receive conventional gingival augmentation procedure with use of Starmatrix collagen membrane

Primary Outcome Measure

increase in keratinized-tissue width [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Harvard Dental CenterBostonMassachusetts02115-

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By research site
Harvard Dental Center· Boston, MA

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