Star Matrix membrane versus your own gum graft to widen the band of firm gum (keratinized gingiva)
Official title: The Clinical Efficacy of Star Matrix Versus Autogenous Gingival Graft in Augmenting Keratinized Tissue Around Teeth- A Split-mouth Randomized Controlled Clinical Trial
Run by Harvard Medical School (HMS and HSDM) · NCT07440303 · Data updated 2026-11-12
This trial will test whether a ready-to-use collagen membrane (Star Matrix) can widen the firm gum band as well as a graft taken from your palate for adults who need more keratinized gingiva.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 80 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Harvard Medical School (HMS and HSDM) Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | November 6, 2025 |
| Main results expected | May 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07440303 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 20–80 with ≤2 mm keratinized tissue on contralateral lower-jaw teeth, generally healthy, with good daily oral hygiene and willing to attend all study visits are ideal candidates.
✕Probably not a fit
People who need root‑coverage rather than simple width augmentation, have active untreated periodontal disease, recent nicotine use, uncontrolled diabetes, recent cancer, pregnancy/breastfeeding, or prior failed grafts at the site are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized split-mouth trial in which 12 adults with narrow keratinized gingiva on opposing lower-jaw teeth will receive Star Matrix on one side and a conventional autogenous free gingival graft from the palate on the other. The primary outcome is the change in keratinized tissue width at six months, with patient-reported pain and morbidity also measured. Secondary outcomes include operative time, early healing scores, esthetic results, and optional histologic analysis of regenerated tissue. Participants will have baseline and scheduled follow-up visits at the Harvard Dental Center to document healing and outcomes.
Why it matters
Potential benefit: If successful, Star Matrix could widen the gum band without creating a second surgical wound, reducing postoperative pain and shortening chair time.
How similar studies have gone: Other soft‑tissue substitutes have been tried but often showed high shrinkage or scarring compared with patient grafts, so Star Matrix is a newer option without established long‑term predictability versus autogenous grafts.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 simple width augmentation * Active, untreated gum disease, cavities, infection, or chronic inflammation near the study teeth * Used cigarettes, e-cigarettes, or other nicotine products within 3 weeks * Insulin-dependent diabetes or hemoglobin A1c \> 6.5 % * Cancer (other than minor skin cancers or in-situ cervical cancer) within the past 5 years * Currently pregnant or breastfeeding * Taking (or soon to begin) drugs that change bone turnover (e.g., bisphosphonates, steroids) * Diseases that disturb bone metabolism (except common osteoporosis) * Auto-immune disease or known allergy to porcine collagen or study materials * Active infection at the planned graft site * Current use of systemic blood thinners (anticoagulants or antiplatelet agents; e.g., warfarin, heparin/LMWH, DOACs such as apixaban/rivaroxaban/dabigatran/edoxaban, or P2Y12 inhibitors such as clopidogrel/prasugrel/ticagrelor)
Where it's running
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Harvard Dental Center
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: David Kim, DDS, DMSc
- Email: dkim@hsdm.harvard.edu
- Phone: (617) 432-1434
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Effect of Free Gingival Graft on Gum Health
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Fixation of Free Gingival Graft with Tissue Tacks vs Criss-Cross Sutures
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.