Peri-implant Soft Tissue Volume Changes at Small Buccal Dehiscences
NCT ID: NCT05466006
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
28 participants
INTERVENTIONAL
2022-09-05
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Subepithelial Connective Tissue Graft (SCTG)
Soft tissue augmentation at peri-implant small buccal dehiscence with subepithelial connective tissue graft harvested from the patient's palate
Soft tissue augmentation with subepithelial connective tissue graft (SCTG)
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.
Volume Stable Collagen Matrix (VCMX)
Soft tissue augmentation at peri-implant small buccal dehiscence with xenogenic volume stable collagen matrix
Soft 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.
Interventions
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Soft tissue augmentation with subepithelial connective tissue graft (SCTG)
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.
Soft 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University of Turin, Italy
OTHER
Responsible Party
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Mario Aimetti
Professor
Locations
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University of Turin
Turin, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Ferrarotti F, Baima G, Mohammadi G, Carboncini C, Romano F, Aimetti M. Peri-Implant Soft Tissue Increase at Small Buccal Bone Dehiscences With Either Volume-Stable Collagen Matrix or Connective Tissue Graft: A Randomized Controlled Trial. Clin Oral Implants Res. 2025 Jul;36(7):846-858. doi: 10.1111/clr.14430. Epub 2025 Mar 19.
Other Identifiers
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GFGTurin2
Identifier Type: -
Identifier Source: org_study_id