Tooth Roots for Lateral Alveolar Ridge Augmentation

Study Overview
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Brief Summary
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A deficient alveolar ridge segment in prepara¬tion for implant placement can be regenerated by several techniques. The type of graft material for each patient depends on many factors such as the anatomy, the morphology of the bone defect, type of prosthodontic rehabilitation and patient or clinician preferences. Bone graft material should have three properties that made it ideal: a) osteoconduction, it provides scaffolds for bone regeneration; b) osteoinduction, it promotes the recruitment of bone-forming cells and formation of bone and c) osteogenesis, induction of cells in the graft to promote regeneration of the bone. Despite of the development of different types of graft material, autogenous bone is still the gold standard for bone augmentation because it exhibits these three mentioned properties. Although it has many advantages, autologous bone has some disadvantages such as high resorption rate up to 50 %, limited source and donor site morbidity. Allografts, xenografts and alloplastic bone graft are materials that are used in everyday practice and over long period, but their disadvantages are numerous in comparison with autologous bone. Allografts can be carrier of some disease and show lack of osteoproliferation, while alloplasts and xenografts show only osteoconduction. According to these facts, it is obvious that there is a need for development an alternative graft material that will surpass these disadvantages.The reconstruction of deficient alveolar ridge defect by the lateral bone augmentation prior to the dental implant placement is predictable and commonly used method. Except animal studies, recent clinical studies showed that there is no difference in the osseointegration of titanium implants in deficient alveolar ridges reconstructed with autogenous cortical bone blocks or autogenous teeth.

Official Title
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Autogenous Tooth Roots for Lateral Alveolar Ridge Augmentation and Staged Implant Placement

Conditions
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Bone Atrophy, Alveolar

Intervention / Treatment
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* Procedure: tooth root augmentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 60 years candidate for lateral ridge augmentation insufficient bone ridge width at the recipient site for implant placement sufficient bone height at the recipient site for implant placement and (e) healthy oral mucosa at least 2 mm keratinized tissue Exclusion Criteria: general contraindications for dental and/or surgical treatments inflammatory and autoimmune disease of the oral cavity, uncontrolled diabetes (HbA1c > 7%) history of chemotherapy or radiotherapy within the past five years, previous immunosuppressant, bisphosphonate or high- dose corticosteroid therapy smokers pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bone defect surgery<br>augmentation on insufficient alveolar ridges with autologous teeth will be performed (wisdom tooth or periodontally compromised tooth) | Procedure: tooth root augmentation<br>* Autogenous tooth roots for lateral alveolar ridge augmentation and staged implant placement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint was defined as the clinical width (CW) of the alveolar ridge | The primary endpoint was defined as the clinical width (CW) of the alveolar ridge being sufficient for the placement of an adequately dimensioned dental implant without the need for a secondary grafting at 6 months after surgery in either group. CW was assessed before (CWa) and after (CWb) augmentation healing period of 6 months in cone-beam computed tomography (CBCT) scans. Measurements were performed to the nearest 0.5mm below the crest using a CBCT. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periimplant tissue stability of augmented sites after prosthetic rehabilitation | Usage of periimplant tissue parameters for assessing the conditions around implants placed in augmented sites using pink esthetic score (PES) that evaluates the esthetic outcome of soft tissue around implant-supported single crowns by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency. | 12 months | 
| gain in ridge width (CWg) | CWg (mm) = CWb ( ridge after surgery in mm)- CWa ( ridge before surgery in mm) | 6 months | 
| soft tissue dehiscences | yes/no for secondary wound healing | 6 months | 
| wound infections | monitoring whether there is an increased incidence of inflammatory conditions after the specified procedure | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone augmentation, autogenous tooth roots, dental implants