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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Pain (VAS scale)(0-10 with higher values indicating worse outcomes)
Study Overview
Brief Summary
This study was designed to assess peri-implant soft tissue health, volume and marginal stability at implants sites which presented small buccal bone dehiscences (<3mm evaluated in a vertical direction) at the time of insertion. Patients will be then randomly allocated to receive grafting with connective tissue graft or volume stable collagen matrix and evaluated at 3 months after surgery and at 12 months of follow up after crown placement.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Pain (VAS scale)(0-10 with higher values indicating worse outcomes)
Time Frame: 12 months
Subjective pain experienced by the patient expressed in a VAS scale
Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)
Time Frame: 12 months
Mean linear change in mm at the buccal aspect 1mm below the soft tissue margin
Mucosal recession at the buccal aspect of the implant site (0-15 mm with higher values indicating worse outcomes)
Time Frame: 12 months
The distance between the crown margin and the mucosal margin
Bleeding on probing (0 no bleeding, 1 presence of bleeding)
Time Frame: 12 months
Bleeding after probing within 15 seconds
Change in Buccal Probing Pocket Depth (PD) at implant site (0-15 mm with higher values representing worse outcomes)
Time Frame: 12 months
The distance between the buccal soft tissue margin and the base of the pocket
Secondary Outcomes
No secondary outcomes reported
Investigators
Mario Aimetti
Professor
University of Turin, Italy