Using Of Chitosan in Alveolar Ridge Preservation

Tooth Extraction Status Nos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06140277
• Other study ID #: PrinceSBAU
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 18, 2023
• Est. completion date: March 20, 2024

Study information

• Verified date: November 2023
• Source: Prince Sattam Bin Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 20, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Augmentation
• Tooth Extraction Status Nos

Intervention

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
• extraction with placing of allograft particles with collagen membrane
to replace the bone at the extraction site we will put allograft particles
• tooth extraction only
hopeless tooth will be extracted without any intervention

Locations

Country	Name	City	State
Saudi Arabia	Prince Sattam Bin Abdulaziz University	Riyadh	Central

Sponsors (1)

Lead Sponsor	Collaborator
Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Hight	Changes in vertical dimension in mm from baseline using scans section from CBCT.	3 months
Primary	Bone volume	Changes in horizontal width in mm from baseline using scans section from CBCT.	3 months
Secondary	Tissue healing	changes in scale of redness of gingiva from baseline	3 months
Secondary	Dry socket	the No of exposed bone from baseline until healing	3 months