Comparing two methods for soft tissue augmentation at dental implant sites
Official title: Vertical Soft Tissue Augmentation With Dermal Matrix and Enamel Matrix Derivative vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences in the Esthetic Zone: A Randomized, Controlled, Clinical, Trial
Run by Harvard Medical School (HMS and HSDM) · NCT05729607 · Data updated 2026-11-12
This study is testing which method works better for improving soft tissue around dental implants by comparing a tissue graft from the patient to a special skin substitute.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 28 (estimated) |
| Sponsor | Harvard Medical School (HMS and HSDM) Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | May 26, 2023 |
| Main results expected | February 27, 2027 |
| Study ends | November 27, 2027 |
| Registry record updated | September 18, 2025 |
| Trial ID | NCT05729607 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are healthy adults aged 18 and older with a single functional dental implant in the anterior region and no significant periodontal issues.
✕Probably not a fit
Patients with systemic conditions that could impair wound healing, such as diabetes or cancer, or those with untreated periodontal diseases will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of two different techniques for vertical soft tissue augmentation in patients with soft tissue dehiscences around dental implants. Participants will be randomly assigned to receive either an autogenous connective tissue graft or an acellular dermal matrix combined with an enamel matrix derivative. The study will evaluate clinical, volumetric, ultrasonographic, and patient-reported outcomes over a period of up to one year to determine which method yields better results.
Why it matters
Potential benefit: If successful, this study could improve outcomes for patients undergoing dental implant procedures by identifying the more effective method for soft tissue augmentation.
How similar studies have gone: Previous studies have shown varying success with similar approaches to soft tissue augmentation, but this specific comparison is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Age ≥ 18 years * Periodontally and systemically healthy * Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth) * Presence of single functional dental implant in the anterior with a PSTD * Implants diagnosed as healthy (Berglundh et al., 2018) Exclusion criteria are: * Contraindications for surgery * Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing * Patients pregnant or attempting to get pregnant (self-reported) * Untreated periodontitis * Untreated peri-implant mucositis or peri-implantitis (Berglundh et al., 2018) * Smoking, defined as self-reported daily habit. Occasional smokers won't be excluded * History of soft tissue grafting at the implant site within the last 6 months
Where it's running
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Harvard School of Dental Medicine
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Lorenzo Tavelli, DDS, MS — Harvard School of Dental Medicine, Boston, USA
- Study coordinator: Lorenzo Tavelli, DDS, MS
- Email: lorenzo_tavelli@hsdm.harvard.edu
- Phone: 734-604-4364
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Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.