Actively Recruiting
Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT
Led by Harvard Medical School (HMS and HSDM) · Updated on 2026-02-27
12
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 20 to 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 with no significant illnesses or medicines that could interfere with healing
- Demonstrates good daily oral hygiene with low plaque levels at baseline
You will not qualify if you...
- Does not meet inclusion criteria or is unlikely to follow the schedule
- Previous gingival graft at the study site that failed
- Needs root-coverage (recession-repair) procedure instead of width augmentation
- Active, untreated gum disease, cavities, infection, or chronic inflammation near study teeth
- Used cigarettes, e-cigarettes, or nicotine products within 3 weeks
- Insulin-dependent diabetes or hemoglobin A1c greater than 6.5%
- Cancer (except minor skin or in-situ cervical cancer) within past 5 years
- Currently pregnant or breastfeeding
- Taking or about to begin drugs that affect bone turnover (e.g., bisphosphonates, steroids)
- Diseases affecting bone metabolism (except common osteoporosis)
- Autoimmune disease or known allergy to porcine collagen or study materials
- Active infection at planned graft site
- Current use of systemic blood thinners such as warfarin, heparin, DOACs, or P2Y12 inhibitors
AI-Screening
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Trial Site Locations
Total: 1 location
1
Harvard Dental Center
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
D
David Kim, DDS, DMSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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