Peri-implant Soft Tissue Changes at Small Buccal Dehiscences

University of Turin, Italy44 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Implants

Interventions

Connective tissue graftPROCEDURE

Following implant placement, a connective tissue graft (CTG) will be harvested from the patient's palate using a standardized technique. The graft will be trimmed and adapted to the buccal aspect of the implant site and stabilized with sutures to increase peri-implant soft tissue thickness. Flap management will be performed to ensure passive adaptation and primary closure. Healing abutments will be placed.

horizontal guided bone regenerationPROCEDURE

Following implant placement, guided bone regeneration (GBR) will be performed at the buccal aspect of the implant using a xenogeneic bone substitute to fill the dehiscence defect. The graft material will be covered with a resorbable collagen membrane, which will be stabilized to ensure defect containment. Flap advancement will be performed to obtain tension-free primary closure. Healing abutments will be placed according to the study protocol.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

C.I.R. Dental School

Torino, Torino, Italy

Outcomes

Primary Outcomes

Buccal soft tissue contour change (profilometric analysis)

Change in buccal soft tissue contour assessed by profilometric analysis through superimposition of digital surface scans (intraoral scans). Linear and/or volumetric changes at the buccal aspect of the implant site will be quantified using dedicated software.