Ridge Splitting With Implant Placement Using Autogenous Tooth Graft

Study Overview
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Brief Summary
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The aim of this study is to evaluate the radiographic and the clinical outcomes of application of the alveolar ridge splitting (ARS) in combination with ATG, associated with immediate implant placement versus ARS in combination with autogenous bone graft, associated with immediate implant placement in patients with horizontal bony insufficiency of alveolar ridges.

Detailed Description
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In cases of a narrow ridge, the alveolar ridge expansion technique by means of hand osteotomes with gradually increasing dimensions was introduced by Tatum and modified by Summers and it can be used regardless of the bone quality. Searching for absolute biocompatible material and taking into account the features of the enamel and dentin, using the tooth as an autologous grafting material was first advocated. Tooth and bone are sharing many characteristics, which supports the idea that tooth could be used as a grafting material. In fact, hydroxyapatite crystals make up the tooth inorganic composition (65%). Moreover, Collagen (mostly type I) and non-collagenic proteins comprised up the tooth organic component (35%). In addition, because autologous tooth graft (ATG) is denser than bone, minimal resorption rates were found to be advantageous to autobone. For the purpose of employing ATG as a grafting material, various methods and techniques have been suggested for developing undemineralized, demineralized or partially demineralized ATG.The outcomes of utilizing undemineralized autologous tooth graft (UATG) around SDIP following RSEA have not yet been evaluated. Therefore, the current trial aimed to assess the clinical and radiological performances of UATG for the treatment of horizontal alveolar ridge deficiencies using RSEA with SDIP. The aim of this study is to evaluate the radiographic and the clinical outcomes of application of the alveolar ridge splitting (ARS) in combination with ATG, associated with immediate implant placement versus ARS in combination with autogenous bone graft, associated with immediate implant placement in patients with horizontal bony insufficiency of alveolar ridges.

Official Title
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Alveolar Ridge Splitting With Simultaneous Implant Placement Using Undemineralized Autogenous Tooth Graft: a Randomized Clinical Trial

Conditions
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Dental Implant Failure Nos, Alveolar Bone Loss, Peri-Implantitis

Intervention / Treatment
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* Procedure: autogenous tooth graft
* Procedure: autogenous bone graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health at the time of surgery At least 3 months of healing after tooth extraction Horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide. Exclusion Criteria: A vertical bone defect in the edentulous ridge; Thick cortex in the labial/buccal with less cancellous bone inside; Obvious undercut on the labial/buccal side; Uncontrolled periodontal conditions or other oral disorders; A history of radiotherapy in the head and neck region

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-center, prospective, single-blinded, randomized parallel two-arm controlled clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I: autogenous bone graft group<br>11 subjects will be assigned to receive alveolar ridge splitting in combination with autogenous bone graft associated with immediate implant placement | Procedure: autogenous bone graft<br>* autogenous bone graft will augment the gap between the splitted ridge and the simultaneously [laced implant fixture<br>|
| Experimental: Group II: autogenous tooth graft group<br>11 subjects will be assigned to receive alveolar ridge splitting in combination with undemineralized autogenous tooth graft associated with immediate implant placement | Procedure: autogenous tooth graft<br>* undemineralized autogenous tooth graft will augment the gap between the splitted ridge and the simultaneously [laced implant fixture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability Quotient of Implants (SQI) | The implant stability was recorded using Osstell TM. Following implant insertion, SQI readings were taken immediately, then again after six and twelve months. | 12-month. | 
| Horizontal bone dimensions (HBDs) | The HBD alterations were assessed by measuring horizontal spacing between the external edges of labial and palatal bony plates at a level 2mm apical of the fixture platform. | 12 months | 
| Peri-implant Bone Density (PBD) | For consistent measurement of the PBD, 1-mm-diameter Region of interest (RI) was selected and traced 1.2 mm distant from the fixture on the cross-sectional slices followed by counting the threshold pixels inside the RI. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pink esthetic score (PES) | Digital intraoral scannings were gathered before surgery, at 6 and 12-months after implantation, to evaluate the PES changes. Seven variables were assessed in relation to a nearby reference teeth: mesial and distal papilla, soft tissue level, colour, texture and shape, and alveolar bone defects. 14 is the maximum possible value for PES. Scoring each parameter on a 0-2 scale: 0 is the minimum score and 2 is the maximum. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ridge splitting, Autogenous Tooth Graft, simultaneous implant placement