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NCT07440303 · ClinicalTrials.gov registry record · NA
Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT
A NA study of Lack of Keratinized Gingiva and Mucogingival Deformity - Insufficient Keratinized Tissue, sponsored by Harvard Medical School (HMS and HSDM).
- Recruiting
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT07440303: Recruiting NA study of Lack of Keratinized Gingiva and Mucogingival Deformity - Insufficient Keratinized Tissue, sponsored by Harvard Medical School (HMS and HSDM).
NCT07440303 is a NA study of Lack of Keratinized Gingiva and Mucogingival Deformity - Insufficient Keratinized Tissue that is actively recruiting participants, run by Harvard Medical School (HMS and HSDM). The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07440303, a NA study of Lack of Keratinized Gingiva and Mucogingival Deformity - Insufficient Keratinized Tissue, is actively recruiting participants, sponsored by Harvard Medical School (HMS and HSDM).
- RECRUITING
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
pre- and post-operative width of keratinized gingiva in the treated area will be measured and compared
Conditions Studied
Interventions
- DEVICE Starmatrix collagen membrane
- OTHER Autogenous gingival graft
Study Locations (1)
Massachusetts
- Harvard Dental Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-11-06 |
| Est. Completion | 2026-10-01 |
| Phase | NA |
What NCT07440303 shows while recruiting
NCT07440303 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Lack of Keratinized Gingiva appearing as the primary indexed condition, and to 2 interventions - of which Starmatrix collagen membrane is the first listed.
NCT07440303 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07440303 about?
NCT07440303 is a clinical study titled "Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT". 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 pro...
What is the current status of trial NCT07440303?
This trial is currently recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2025-11-06. Estimated completion is 2026-10-01.
What conditions does trial NCT07440303 study?
This clinical trial studies the following conditions: Lack of Keratinized Gingiva, Mucogingival Deformity - Insufficient Keratinized Tissue.
What interventions are being tested in trial NCT07440303?
The interventions under investigation include: Starmatrix collagen membrane (DEVICE), Autogenous gingival graft (OTHER).
Who is sponsoring clinical trial NCT07440303?
This trial is sponsored by Harvard Medical School (HMS and HSDM), which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07440303 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07440303's enrollment target sits among peer trials
12 1914th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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