Star Matrix vs. Autogenous Graft for Gum Augmentation

This study is comparing two ways to widen thin or missing gum tissue (gingival augmentation). One method uses a new, ready-to-use collagen membrane called Star Matrix. The other, standard method takes a small piece of your own gum tissue from the roof of your mouth (autogenous gingival graft). We want to see if Star Matrix can work as well as the standard method to increase the width of your protective gum tissue. You might be able to join if you are an adult between 20 and 80 years old, need gum augmentation on both sides of your lower jaw, and are generally healthy. The main goal is to measure how much the gum tissue widens after 6 months with each treatment. The current status of this study is unclear.

Study design
This is a randomized controlled trial involving 12 participants. It is a "split-mouth" study, meaning each participant will receive both treatments in different areas of their mouth.
What's involved
You would need to sign a consent form, follow study instructions, and return for all required visits. The primary measurement for success is taken at 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 6 months after treatment.

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NCT07440303

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

Recruiting
NAAges 20–80InterventionalTreatment
Harvard Medical School (HMS and HSDM)
~12 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Starmatrix collagen membraneAutogenous gingival graft

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
increase in keratinized-tissue width
Measured over 6 months
Lack of Keratinized Gingiva
Mucogingival Deformity - Insufficient Keratinized Tissue
1 sites across 1 states
Massachusetts1

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Eligibility criteria

Inclusion

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

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)
  • increase in keratinized-tissue width6 months

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