Using Of Chitosan in Alveolar Ridge Preservation

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Augmentation; Tooth Extraction Status Nos
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Saudi Arabia
  • Central
    • Riyadh, Central, Saudi Arabia, 16273
      • Prince Sattam Bin Abdulaziz University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chitosan; 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; to replace the bone at the extraction site we will put either chitosan or allograft particles; Other Names: chitosan
Active Comparator: Allograft; 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; to replace the bone at the extraction site we will put allograft particles; Other Names: gold standard treatment
Placebo Comparator: placebo; the extraction will be done without placing any bone material inside	Procedure: tooth extraction only; hopeless tooth will be extracted without any intervention; Other Names: normal extraction

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Prince Sattam Bin Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): March 20, 2024

Study Registration Dates

• First Submitted: July 9, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: chitosan; socket preservation
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Chitosan
• Other Study ID Numbers: PrinceSBAU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No