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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connective tissue graft | Experimental | Autogenous connective tissue graft harvested from the palate and placed at the buccal aspect of the implant at the time of implant placement. |
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| Horizontal guided bone regeneration | Active Comparator | Guided bone regeneration using xenogeneic bone substitute and resorbable collagen membrane at the buccal aspect of the implant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connective tissue graft | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after prosthetic loading |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Bone Level (MBL) change | 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. | 12 months after prosthetic loading |
| Mucosal thickness gain |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.I.R. Dental School | Torino | Torino | 10126 | Italy |
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| horizontal guided bone regeneration | Procedure | 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. |
|
Peri-implant mucosal thickness measured at the mid-buccal aspect using a standardized superimposition software. |
| 12 months after prosthetic loading |
| Width of keratinized mucosa | Width of keratinized mucosa measured from the mucogingival junction to the free gingival margin at the mid-buccal aspect. | 12 months after prosthetic loading |
| Pink Esthetic Score | Esthetic evaluation using the Pink Esthetic Score (PES) assessed from standardized photographs by blinded examiners. | 12 months after prosthetic loading |