Assessing soft tissue changes around dental implants with small bone defects
Peri-implant Soft Tissue Volume Changes After Treatment of Small Buccal Dehiscence With Volume-stable Collagen Matrix or Connective Tissue Graft: a Randomized Controlled Clinical Trial
NA · University of Turin, Italy · NCT05466006
This study is testing whether using a connective tissue graft or a collagen matrix can improve the health of soft tissue around dental implants with small bone defects.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Turin, Italy (other) |
| Locations | 1 site (Turin) |
| Trial ID | NCT05466006 on ClinicalTrials.gov |
What this trial studies
This study evaluates the health and stability of soft tissue around dental implants that have small buccal bone dehiscences of less than 3mm at the time of insertion. Patients will be randomly assigned to receive either a connective tissue graft or a volume stable collagen matrix to augment the soft tissue. The outcomes will be assessed at three months post-surgery and again at twelve months after crown placement to determine the effectiveness of each intervention.
Who should consider this trial
Good fit: Ideal candidates are adults with a single tooth edentulous space and a small buccal bone dehiscence of 3mm or less.
Not a fit: Patients under 18, pregnant or lactating women, heavy smokers, and those with contraindications for surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the outcomes of dental implant procedures by enhancing soft tissue health and stability.
How similar studies have performed: Similar studies have shown promising results in soft tissue augmentation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Single tooth edentulous space * Expected small buccal bone dehiscence (≤3mm evaluated in a vertical direction) assessed according to the prosthetically guided position of an implant of 4 mm in diameter planned using the pre-surgical CBCT * Completed non-surgical periodontal therapy (if needed) * FMPS and FMBS \< 20% Exclusion Criteria: * Age \< 18 years old * Pregnancy or lactation * Heavy smokers (\> 10 cigarette/day) * Conditions or diseases contraindicating surgical interventions * Absence of the expected small buccal bone dehiscence (≤3mm evaluated in a vertical direction) verified after implant placement * Need for bone regeneration at the implant site
Where this trial is running
Turin
- University of Turin — Turin, Italy (RECRUITING)
Study contacts
- Study coordinator: Mario Aimetti
- Email: mario.aimetti@unito.it
- Phone: 00390116331546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dental Implants