Dental Implants Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | June 30, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | University of Turin | Turin |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume) | Mean linear change in mm at the buccal aspect 1mm below the soft tissue margin | 12 months | |
Primary | Change in Buccal Probing Pocket Depth (PD) at implant site (0-15 mm with higher values representing worse outcomes) | The distance between the buccal soft tissue margin and the base of the pocket | 12 months | |
Primary | Mucosal recession at the buccal aspect of the implant site (0-15 mm with higher values indicating worse outcomes) | The distance between the crown margin and the mucosal margin | 12 months | |
Primary | Pain (VAS scale)(0-10 with higher values indicating worse outcomes) | Subjective pain experienced by the patient expressed in a VAS scale | 12 months | |
Primary | Bleeding on probing (0 no bleeding, 1 presence of bleeding) | Bleeding after probing within 15 seconds | 12 months |
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