Dental Implants
Conditions
Brief summary
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
Interventions
PROCEDUREConnective tissue graft
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.
PROCEDUREhorizontal guided bone regeneration
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.
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Buccal soft tissue contour change (profilometric analysis) | 12 months after prosthetic loading | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Level (MBL) change | 12 months after prosthetic loading | Change in marginal bone levels measured on standardized periapical radiographs using customized holders. Measurements will be taken from the implant shoulder to the first bone-to-implant contact. |
| Mucosal thickness gain | 12 months after prosthetic loading | Peri-implant mucosal thickness measured at the mid-buccal aspect using a standardized superimposition software. |
| Width of keratinized mucosa | 12 months after prosthetic loading | Width of keratinized mucosa measured from the mucogingival junction to the free gingival margin at the mid-buccal aspect. |
| Pink Esthetic Score | 12 months after prosthetic loading | Esthetic evaluation using the Pink Esthetic Score (PES) assessed from standardized photographs by blinded examiners. |
Countries
Italy
Outcome results
None listed