Pontic-shield Technique in Alveolar Ridge Preservation

Study Overview
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Brief Summary
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Alveolar bone resorption after dental extraction frequently leads to situations in which long-term function and esthetic success of rehabilitations with dental implants is a challenge. Pontic-shield has been described as an alternative technique to maintain alveolar ridge after tooth extraction. The aim of this study is to analyze the effectiveness of Pontic-shield technique in alveolar ridge preservation comparing to fresh socket and ridge preservation using deproteinized bovine bone and a porcine collagen membrane.

Detailed Description
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A three-arm randomized clinical study will be conducted: Group 1 (study group): Ridge preservation with Pontic-shield technique. Group 2 (positive control): Ridge preservation with deproteinized bovine bone and porcine collagen membrane after tooth extraction. Group 3 (negative control): Tooth extraction only (fresh socket). A cone-beam computed tomography will be performed prior to tooth extraction and 4 months postoperative. Radiographic changes between before and after intervention will be evaluated to asses the effectiveness of Pontic-shield technique.

Official Title
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Effectiveness of Pontic-shield Technique in Alveolar Ridge Preservation: A Randomized Controlled Trial

Conditions
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Tooth Extraction Status Nos, Bone Loss, Bone Resorption

Intervention / Treatment
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* Procedure: Pontic-shield technique
* Procedure: Alveolar ridge preservation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient from 18 to 80 years old Patients who sign the informed consent Need to perform extraction from second premolar to second premolar in maxilla and mandible Exclusion Criteria: Tobacco consumption (more than 10 cigarettes per day) Severe systemic disease ( ASA III or IV - American Society of Anaesthesiology) Drug use that could interfere with alveolar bone healing Active periodontal disease Acute or chronic apical pathology of the tooth

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Parallel three-arm randomized clinical study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Pontic-shield will be performed as ridge preservation technique. | Procedure: Pontic-shield technique<br>* A 1mm thick fragment of the vestibular aspect of the root will remain after extraction (partial extraction)<br>* Other names: Partial extraction therapy;|
| Active Comparator: Positive control (ridge preservation)<br>Deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction. | Procedure: Alveolar ridge preservation<br>* Particulate deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction<br>|
| No Intervention: Negative control (fresh socket)<br>No intervention will be performed after tooth extraction. Blood clot will be maintained after extraction. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone resorption | Radiographic changes between preoperative (prior to tooth extraction) and postoperative (4 months after intervention) will be analyzed. This variation will be assessed by measuring changes in width and height (in millimeters) of the socket by superimposition of CBCT before and after the intervention. | From the day of the extraction to 4 months after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction assessed by visual analogue scale (VAS) | Postoperative pain with visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain) | From the day of the surgical procedure to the seventh-day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth extraction, Alveolar ridge preservation, Partial extraction therapies, Bone resorption