Evaluation of Post-extraction Socket Preservation With Camelline Versus Bovine Deproteinized Xenograft

Study Overview
=================
Brief Summary
-----------------
Alveolar ridge preservation following tooth extraction has the ability to maintain the ridge dimensions and allow the implant placement in an ideal position fulfilling both functional and aesthetic results. Postextraction socket healing commonly results in resorption of the alveolar ridge. To prevent this clinical situation, different authors have described several surgical procedures, ranging from regenerative techniques for socket preservation to immediate implant placement. Regenerative techniques have been widely tested in controlled and uncontrolled studies with various materials and clinical approaches: bone grafting alone, including autografts, allografts, xenografts, and alloplasts; membrane alone, whether absorbable or not; and membrane in conjunction with grafting.

Detailed Description
-----------------
Various classic studies in the 1960s showed that the resorption process of the postextraction alveolus in both jaws was significantly more pronounced on the buccal aspect. This comes as no surprise, as the buccal surface of the anterior alveolar ridge is commonly thin and fragile. The maxilla tends to exhibit greater reductions in width than in height. The loss of tissue contour takes place mostly during the first 1 to 3 months following tooth extraction. Because the healing patterns of human sockets are unpredictable architecture), then such common procedures as extractions may lead to intraoral situations in which the remaining healed ridge does not allow for an esthetic and functional solution without the aid of significant bone grafting.

Official Title
-----------------
Evaluation of Post-extraction Socket Preservation With Camelline Versus Bovine Deproteinized Xenograft (Pilot Trial)

Conditions
-----------------
Socket Preservation

Intervention / Treatment
-----------------
* Procedure: socket preservation procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Teeth with: root fractures, endodontic treatment failures, advanced caries lesions or any other cause that make tooth non-restorable and indicated for extraction. Healthy non-smoker patients Exclusion Criteria: Medically compromised patients. Pregnant females. History of malignancy or radiotherapy/chemotherapy for malignancy in the past 5 years. History of active bone metabolic disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: pilot randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: socket preservation with camelline bone<br>natural hydroxyapatite derived from camels prepared by investigator | Procedure: socket preservation procedure<br>* socket preservation of post extraction site using bone xenografts<br>* Other names: alveolar ridge preservation;|
| Active Comparator: socket preservation with bovine bone<br>natural hydroxyapatite derived from cows (Bio-Oss) | Procedure: socket preservation procedure<br>* socket preservation of post extraction site using bone xenografts<br>* Other names: alveolar ridge preservation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient-reported outcome | assessment of post-operative complication( pain, swelling, bleeding, infection) | within first week postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ridge contour changes | dimentional changes after extraction and socket preservation | 3 month, 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone grafts, xenograft