Using Of Chitosan in Alveolar Ridge Preservation

Phase 2

Active, not recruiting

• Conditions: Bone Augmentation; Tooth Extraction Status Nos
• Interventions: Procedure: tooth extraction only; Procedure: extraction with chitosan particles as a replacement for bone graft with collagen membrane; Procedure: extraction with placing of allograft particles with collagen membrane

• Registration Number: NCT06140277
• Lead Sponsor: Prince Sattam Bin Abdulaziz University

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-01-18
• Study First Submitted: 2023-07-09
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2023-12-01
• Study Completion: 2024-03-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	tooth extraction only	the extraction will be done without placing any bone material inside
Chitosan	extraction with chitosan particles as a replacement for bone graft with collagen membrane	group will be treated using chitosan as a replacement of bone particles with collagen membrane after tooth extraction
Allograft	extraction with placing of allograft particles with collagen membrane	after extraction, the group will be treated using the gold standard protocol which is the (allograft) bone particles with collagen membrane.

Primary Outcome Measures

Name	Time	Method
Bone Hight	3 months	Changes in vertical dimension in mm from baseline using scans section from CBCT.
Bone volume	3 months	Changes in horizontal width in mm from baseline using scans section from CBCT.

Secondary Outcome Measures

Name	Time	Method
Dry socket	3 months	the No of exposed bone from baseline until healing
Tissue healing	3 months	changes in scale of redness of gingiva from baseline

Trial Locations

Locations (1)

Prince Sattam Bin Abdulaziz University; 🇸🇦 Riyadh, Central, Saudi Arabia