Using Of Chitosan in Alveolar Ridge Preservation

Study Overview
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Brief Summary
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The goal of this clinical trial is to assess the efficacy of chitosan as a socket preservation material after tooth extraction in compare to the standard treatment. The study will include patients who exhibit hopeless tooth without any periodontal infection. Smokers, history of allergy, patients with major medical issue and pregnant women will be excluded from the study. The main question[s] to answer is : is there a significant difference in bone density and dimension between the test and control groups after tooth extraction or not. Participants will be asked to do CBCT scan and take upper and lower impressions before extraction and after three month from extraction. Then, the patients will randomly assigned to one from these groups: There will be a total of three groups (10 patients for each), first group will be treated using mixed of chitosan and allograft, second group will be treated using allograft alone and the last group will be used as control. All patients will be treated in accordance with the 2013 Declaration of Helsinki.

Detailed Description
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To evaluate the tissue response, intraoral impressions and X-ray will be taking from each patient before extraction and three months after. Also, Cone-beam computed tomography (CBCT) will be taking to measure the bone growth at base line and three months after surgery is done. For measurement, each socket will be vertically divided into 3 equal areas: coronal, middle, and apical. Regenerated bone density will be assessed in each area, in both control and intervention groups. Data then can be analyzed using SPSS ver. 11 (SPSS Inc., Chicago,USA). P-values less than 0.05 were considered as significant.

Official Title
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Using Of Chitosan in Alveolar Ridge Preservation: Randomized Clinical Trial.

Conditions
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Tooth Extraction Status Nos, Bone Augmentation

Intervention / Treatment
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* Procedure: extraction with chitosan particles as a replacement for bone graft with collagen membrane
* Procedure: extraction with placing of allograft particles with collagen membrane
* Procedure: tooth extraction only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of hopeless tooth. Healthy patient. Healthy gingiva without any periodontal disease. Patient is welling to come after three months. Exclusion Criteria: Smokers. History of allergy. pregnant women. patient with systemic disease.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be a total of 3 groups (10 patients for each), first group will be treated using chitosan as a replacement of bone particles with collagen membrane. 2nd group will be treated using the gold standard protocol which is the allograft bone particles with collagen membrane, and the last group will received nothing as control
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chitosan<br>group will be treated using chitosan as a replacement of bone particles with collagen membrane after tooth extraction | Procedure: extraction with chitosan particles as a replacement for bone graft with collagen membrane<br>* to replace the bone at the extraction site we will put either chitosan or allograft particles<br>* Other names: chitosan;|
| Active Comparator: Allograft<br>after extraction, the group will be treated using the gold standard protocol which is the (allograft) bone particles with collagen membrane. | Procedure: extraction with placing of allograft particles with collagen membrane<br>* to replace the bone at the extraction site we will put allograft particles<br>* Other names: gold standard treatment;|
| Placebo Comparator: placebo<br>the extraction will be done without placing any bone material inside | Procedure: tooth extraction only<br>* hopeless tooth will be extracted without any intervention<br>* Other names: normal extraction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Hight | Changes in vertical dimension in mm from baseline using scans section from CBCT. | 3 months | 
| Bone volume | Changes in horizontal width in mm from baseline using scans section from CBCT. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue healing | changes in scale of redness of gingiva from baseline | 3 months | 
| Dry socket | the No of exposed bone from baseline until healing | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chitosan, socket preservation