Star Matrix membrane versus your own gum graft to widen the band of firm gum (keratinized gingiva)
The Clinical Efficacy of Star Matrix Versus Autogenous Gingival Graft in Augmenting Keratinized Tissue Around Teeth- A Split-mouth Randomized Controlled Clinical Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Harvard Medical School (HMS and HSDM) Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07440303 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.