Dental Implants
Conditions
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.
Interventions
After the assessment of the vestibular bone dehiscence at implant site from the most apical extension of the trans-mucosal implant collar (≤3 mm evaluated in a vertical direction), SCTG will be harvested from the palate and sutured to the flap. Simple interdental sutures will be performed in order to stabilize the flap in close contact with the healing screw.
PROCEDURESoft tissue augmentation with xenogenic volume stable collagen matrix (VCXM)
After the assessment of the vestibular bone dehiscence at implant site from the most apical extension of the trans-mucosal implant collar (≤3 mm evaluated in a vertical direction), VCMX will be sutured to the flap and simple interdental sutures will be performed in order to stabilize the flap in close contact with the healing screw.
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume) | 12 months | Mean linear change in mm at the buccal aspect 1mm below the soft tissue margin |
| Change in Buccal Probing Pocket Depth (PD) at implant site (0-15 mm with higher values representing worse outcomes) | 12 months | The distance between the buccal soft tissue margin and the base of the pocket |
| Mucosal recession at the buccal aspect of the implant site (0-15 mm with higher values indicating worse outcomes) | 12 months | The distance between the crown margin and the mucosal margin |
| Pain (VAS scale)(0-10 with higher values indicating worse outcomes) | 12 months | Subjective pain experienced by the patient expressed in a VAS scale |
| Bleeding on probing (0 no bleeding, 1 presence of bleeding) | 12 months | Bleeding after probing within 15 seconds |
Countries
Italy
Contacts
Primary ContactMario Aimetti
Outcome results
None listed