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

NCT07440303 | Recruiting DMC FDA Device

• 1 other identifier: IRB25-0932
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

mucogingival deformity

Outcome Measures

Primary Outcomes (1)

• increase in keratinized-tissue width

  pre- and post-operative width of keratinized gingiva in the treated area will be measured and compared

  6 months

Secondary Outcomes (2)

• pain level

  7 days

• color matching

  6 months

Study Arms (2)

Autogenous gingival graft/ free gingival graft (FGG)

ACTIVE COMPARATOR

the area will receive conventional gingival augmentation procedure with use of autogenous gingival graft/ free gingival graft (FGG)

Other: Autogenous gingival graft

Starmatrix collagen membrane

EXPERIMENTAL

the area will receive conventional gingival augmentation procedure with use of Starmatrix collagen membrane

Device: Starmatrix collagen membrane

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.

Starmatrix collagen membrane

Autogenous gingival graft OTHER

gingival insufficiency will be treated with autogenous gingival graft

Autogenous gingival graft/ free gingival graft (FGG)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead

Study Sites (1)

Harvard Dental Center

Boston, Massachusetts, 02115, United States

RECRUITING

Central Study Contacts

David Kim, DDS, DMSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomized split-mouth study

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: November 6, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)