Impact of a Alveolar Ridge Preservation Technique on the Need of Performing Guided Bone Regeneration for Dental Implant Placement

Study Overview
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Brief Summary
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The aim of this study is to investigate how a socket preservation procedure may reduce the need of guided bone regeneration surgery after tooth extraction and facilitate the placement of a dental implant in the optimal, prosthetic-driven position.

Detailed Description
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The main gol of the study is to assess the efficacy of a socket preservation procedure in reducing the need of additional surgeries in order to augment alveolar bone volume before placing a dental implant in optimal position. Bone volume at 6 months will be compared to initial volume in order to assess volume variations and how they affect the positioning of a prosthetically driven, implant.

Official Title
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Impact of Alveolar Ridge Preservation on Optimal Implant Placement

Conditions
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Tooth Avulsion

Intervention / Treatment
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* Procedure: Tooth extraction and Alveolar ridge preservation
* Procedure: Tooth extraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years of age at least one intercalate tooth to be extracted, with complete alveolus and no soft tissue recession; adequate oral hygiene, i.e. plaque index score ≤10%; mesial-distal width of inter-dental space ≥7 mm; Exclusion Criteria: American Society of Anesthesiologists (ASA) score ≥III presence of active periodontitis, clinically diagnosed in presence of probing depths ≥4 mm and bleeding on probing a history of radiotherapy to the head and neck region presence of conditions requiring chronic use of antibiotics medical conditions requiring prolonged use of steroids history of leucocyte dysfunction history of bleeding disorders history of renal failure patients with metabolic bone disorders patients with uncontrolled endocrine disorders disability affecting oral hygiene alcohol or drug abuse HIV infection smoking >10 cigarettes a day or cigar equivalents conditions or circumstances that would prevent completion of study participation mucosal diseases presence of osseous lesions severe bruxing or clenching habits persistent intraoral infections compromised alveolus (dehiscence, etc)

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alveolar Ridge Preservation<br>Patients in this arm will undergo atraumatic extraction of an hopeless tooth and a socket preservation procedure. Alveolar ridge preservation will be performed using a slow-resorption bone substitute and a collagen membrane that covers the graft. | Procedure: Tooth extraction and Alveolar ridge preservation<br>* Tooth extraction and alveolar ridge preservation with deproteinized bovine bone mineral and a collagen matrix seal<br>* Other names: Socket preservation;|
| Active Comparator: Natural healing<br>Patients in this arm will undergo atraumatic extraction of an hopeless tooth. The socket will follow natural healing. | Procedure: Tooth extraction<br>* Tooth extraction and socket natural healing<br>* Other names: Socket natural healing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of implants ideally placed | The main goal is to determine if alveolar ridge preservation affects optimal implant positioning. This is defined as the implant position allowing to fulfill the ideal prosthetic design of the crown to be restored. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-implant bone variation | Crestal bone levels (CBL): distances from the implant shoulder to the most coronal bone to implant contact measured on X-rays with a millimeter ruler to the nearest 0.5 mm. Two measurements will be taken for each implant: mesially and distally | 6 months | 
| Ridge volume at 6 months after tooth extraction | The comparison of baseline and control cone.beam computed tomography and of clinical data in test and control groups will allow to determine volumetric effects on bone and soft tissues of socket preservation. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Socket preservation, Single implant, Tooth extraction