Trials Sponsors Conditions Drugs Pricing

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 membraneDevice

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 graftOther

gingival insufficiency will be treated with autogenous gingival graft

Eligibility Criteria

Age20 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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

Sponsors & Collaborators

Harvard Medical School (HMS and HSDM)
Otherlead

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

Study Record Dates

First Submitted

February 23, 2026

First Posted

February 27, 2026

Study Start

November 6, 2025

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Autogenous gingival graft/ free gingival graft (FGG)

Starmatrix collagen membrane

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Autogenous gingival graft/ free gingival graft (FGG)

Starmatrix collagen membrane

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations