NCT06140277

Using Of Chitosan in Alveolar Ridge Preservation

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Prince Sattam Bin Abdulaziz University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tooth Extraction Status Nos
• Bone Augmentation

Interventions

Type	Name	Description
PROCEDURE	extraction with chitosan particles as a replacement for bone graft with collagen membrane	to replace the bone at the extraction site we will put either chitosan or allograft particles
PROCEDURE	extraction with placing of allograft particles with collagen membrane	to replace the bone at the extraction site we will put allograft particles
PROCEDURE	tooth extraction only	hopeless tooth will be extracted without any intervention

Timeline

• Start date: 2023-01-18
• Primary completion: 2023-12-01
• Completion: 2024-03-20
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: Saudi Arabia