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Compares treatment options for Lack of Keratinized Gingiva
Official title Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT
ClinicalTrials.gov ID: NCT07440303
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 80. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join if
- 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 %
See the full eligibility criteria
- 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).
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.