Health TrialsbyHealthPanel

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

ConditionsLack of Keratinized GingivaMucogingival Deformity - Insufficient Keratinized Tissue
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorHarvard Medical School (HMS and HSDM)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Autogenous gingival graft

    Other intervention

    gingival insufficiency will be treated with autogenous gingival graft

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Autogenous gingival graft/ free gingival graft (FGG)Active comparator 1 intervention
Group B: Starmatrix collagen membraneExperimental treatment 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

pain level

p't will be given a scale of 0-10 for pain experienced during the first week after procedure

Time frame
7 days
2

color matching

standardized photographs will be used to evaluate gingival color

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Harvard Medical School (HMS and HSDM)

Lead sponsor

Source ClinicalTrials.gov
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