Peri-implant Soft Tissue Changes at Small Buccal Dehiscences

University of Turin

Status: Completed

Conditions: Dental Implants

Treatments: Procedure: Connective tissue graft; Procedure: horizontal guided bone regeneration

Study type: Interventional

Funder types: Other

Identifiers

NCT07501715

GFGTurin3

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 guided bone regeneration and evaluated at 3 months after surgery and at 12 months of follow up after crown placement

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults ≥18 years of age
• Patients requiring a single dental implant in a healed site in the posterior region (premolar or molar areas)
• Presence of a buccal bone dehiscence defect at implant placement, defined as a vertical defect of the buccal bone plate ≥1 mm and ≤3 mm measured from the implant shoulder after implant insertion
• Adequate residual bone to allow implant placement with primary stability (insertion torque ≥25 Ncm or ISQ ≥60)
• Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤20%
• Patients able to understand and sign informed consent
• Patients willing to comply with study procedures and follow-up visits

Exclusion criteria

• Uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus, HbA1c >7.5%)
• Immunocompromised patients
• History of radiotherapy in the head and neck region
• Use of medications affecting bone metabolism (e.g., bisphosphonates, denosumab)
• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Connective tissue graft

Experimental group

Description:

Autogenous connective tissue graft harvested from the palate and placed at the buccal aspect of the implant at the time of implant placement.

Treatment:

Procedure: Connective tissue graft

Horizontal guided bone regeneration

Active Comparator group

Description:

Guided bone regeneration using xenogeneic bone substitute and resorbable collagen membrane at the buccal aspect of the implant.

Treatment:

Procedure: horizontal guided bone regeneration