The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla

Study Overview
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Brief Summary
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This study is designed to assess the effects of Alveolar Ridge Preservation (ARP) after tooth extraction compared to extraction alone in the posterior maxilla. The results of this study will demonstrate if the use of ARP reduces alveolar ridge resorption at 6 months post extraction in the posterior maxilla region.

Detailed Description
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Fifteen subjects requiring extraction of one posterior tooth in the right maxilla and one posterior tooth in the left maxilla will be considered for enrollment. Subjects who meet the inclusion and exclusion criteria will be randomized to receive alveolar ridge preservation on one side of the maxilla and only an extraction on the other side of the maxilla. Extraction of the failing teeth will be performed atraumatically; a mucoperiosteal flap will not be employed. After removal of the tooth, the alveolus will be meticulously debrided and cleaned. In the test site, the socket will be filled with xenograft and a collagen membrane. In the control site, no graft material or collagen membrane will be used. Clinical measurements, standardized peri-apical radiographs and Cone Beam Computed Tomography scans will be performed immediately following tooth extractions (visit 2) and 6 months (visit 4) after extractions. Subjects will be examined over the course of 6 months. Investigators will be trained prior to participating in the study. Training will be undertaken during a site initiation visit and will include a detailed description of all study procedures including treatment methods, and measurement methods to obtain study endpoints.

Official Title
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The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla: A Randomized, Split-Mouth, Controlled Trial.

Conditions
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Tooth Extraction

Intervention / Treatment
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* Device: Xenograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must voluntarily sign the informed consent form. Subjects must be male or female who are at least 20-70 years of age. Subjects must be able and willing to follow study procedures and instructions. Presence of one posterior tooth in the right maxilla and one posterior tooth in the left maxilla that require extraction (ADA tooth positions 2-4 and 13-15). The same type of tooth should be in booth side, either two molars or two premolars. Teeth extractions of one posterior tooth in the right maxilla and one posterior tooth in the left maxilla must be completed successfully (ADA tooth positions 2-4 and 13-15). If present, teeth adjacent to the teeth slated for extraction must be healthy. Healthy teeth are defined as asymptomatic teeth without periapical lesions. Exclusion Criteria: Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study. Subjects who have failed to maintain good plaque control. Subjects with any systemic condition such as uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, intravenous and oral bisphosphonate therapy, bone metabolic diseases, history of irradiation of the head and neck area, or any other immuno-suppressive therapy that would contraindicate oral surgical treatment. Subjects who report allergy or hypersensitivity to any of the products (collagen membrane and ABBM) used throughout the study. Presence of ≥3 mm of vertical loss of the buccal bone in relation to the palatal wall. Subjects with untreated periodontitis. Presence of acute dentoalveolar infections in the teeth slated for extraction. Subjects who are heavy smokers (defined as >10 cigarettes per day or >1 cigar per day) or chew tobacco, including within 3 months prior to enrollment. Subjects with conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non- compliance or unreliability

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Treatment<br>Tooth extraction with no bone graft. | |
| Active Comparator: Alveolar Ridge Preservation Treatment<br>Tooth extraction followed by alveolar ridge preservation using xenograft bone graft and covered by a resorbable collagen membrane. | Device: Xenograft<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the bucco-palatal width of the alveolar ridge measured in mm. | Changes in the bucco-palatal width of alveolar ridge from baseline to 6 months, measured using CBCT data. | 6 Months | 
| Changes in the vertical height of the alveolar ridge measured in mm. | Changes in the vertical height of the alveolar ridge measured using Cone Beam Computed Tomography (CBCT) data and periapical radiographs. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar bone volumetric changes measured in mm. | Alveolar bone volumetric changes measured using CBCT data and from dental impressions. | 6 Months | 
| Changes in the distance from the alveolar crestal bone to the sinus floor measured in mm. | Changes in the distance from the alveolar crestal bone to the sinus floor using CBCT data and standardized periapical radiographs. | 6 months | 
| Bone density changes from measured in mm. | Bone density changes measured using CBCT data. | 6 Months | 
| Changes in keratinized mucosa width and thickness measured in mm. | Changes in keratinized mucosa width and thickness. | 6 months | 
| Correlation of soft tissue and buccal bone wall thickness measured in mm. | Correlation of soft tissue and buccal bone wall thickness on radiographic outcomes. | 6 months | 
| Subject satisfaction will be assessed through questionnaire. | Subject satisfaction will be assessed using a Visual Analogue Scale (VAS) (scored from 0-100) after extraction (visit 2), at 2 weeks (visit 3) and 6 months (visit 4) following tooth extractions. | 6 Months | 
| Need for additional bone augmentation, including sinus bone augmentation measured in mm. | Need for additional bone augmentation, including sinus bone augmentation, prior to implant placement at 6 months post extractions | 1.5 Years | 
| Implant success rate measured by percentage. | Evaluate dental implant success, in case the subject receives dental implant following healing of alveolar ridge after teeth extractions | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alveolar Ridge Preservation, Xenograft bone graft, Collagen membrane