Peri-implant Soft Tissue Volume Changes at Small Buccal Dehiscences

University of Turin

Status: Enrolling

Conditions: Dental Implants

Treatments: Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM); Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG)

Study type: Interventional

Funder types: Other

Identifiers

NCT05466006

GFGTurin2

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Subepithelial Connective Tissue Graft (SCTG)

Active Comparator group

Description:

Soft tissue augmentation at peri-implant small buccal dehiscence with subepithelial connective tissue graft harvested from the patient's palate

Treatment:

Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG)

Volume Stable Collagen Matrix (VCMX)

Experimental group

Description:

Soft tissue augmentation at peri-implant small buccal dehiscence with xenogenic volume stable collagen matrix

Treatment:

Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM)