Recruiting

Star Matrix vs. Graft

Sponsor:

Harvard Medical School (HMS and HSDM)

Code:

NCT07440303

Conditions

Lack of Keratinized Gingiva

Mucogingival Deformity - Insufficient Keratinized Tissue

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

Starmatrix collagen membrane

Autogenous gingival graft

Study Details

Brief summary:

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

Lack of Keratinized Gingiva

Mucogingival Deformity - Insufficient Keratinized Tissue

Study ID

NCT07440303

Start date

Nov 6, 2025

Status verified date

Feb, 2026

Completion date

Oct 1, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Starmatrix collagen membrane

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

gingival insufficiency will be treated with autogenous gingival graft

Primary outcome measure

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

Central Contacts and Locations

Central contacts

David Kim, DDS, DMSc

(617) 432-1434dkim@hsdm.harvard.edu

Locations

Harvard Dental Center

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Harvard Medical School (HMS and HSDM)

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • mucogingival deformity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Harvard Medical School (HMS and HSDM) on 2026-02-27.