Using Of Chitosan in Alveolar Ridge Preservation

NCT06140277 | Unknown Phase 2 DMC

• 1 other identifier: PrinceSBAU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Extraction Status Nos; Bone Augmentation

Keywords

chitosan; socket preservation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Tissue healing

  3 months

• Dry socket

  3 months

Study Arms (3)

Chitosan

EXPERIMENTAL

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

Allograft

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

the extraction will be done without placing any bone material inside

Procedure: tooth extraction only

Interventions

extraction with chitosan particles as a replacement for bone graft with collagen membrane PROCEDURE

to replace the bone at the extraction site we will put either chitosan or allograft particles

Also known as: chitosan

Chitosan

extraction with placing of allograft particles with collagen membrane PROCEDURE

to replace the bone at the extraction site we will put allograft particles

Also known as: gold standard treatment

Allograft

tooth extraction only PROCEDURE

hopeless tooth will be extracted without any intervention

Also known as: normal extraction

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of hopeless tooth.
• Healthy patient.
• Healthy gingiva without any periodontal disease.
• Patient is welling to come after three months.

You may not qualify if:

• Smokers.
• History of allergy.
• pregnant women.
• patient with systemic disease.

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

Study Sites (1)

Prince Sattam Bin Abdulaziz University

Riyadh, Central, 16273, Saudi Arabia

Location

MeSH Terms

Interventions

Bone Transplantation; Chitosan

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation; Chitin; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: For randomization, The investigator will send a form to the study therapist who is not involved in assessing outcome of the study. This form will include a randomization number. In the clinic, closed envelopes with printed randomization numbers on it are available. For every randomization number the corresponding code for the therapy group of the randomization list will be found inside the envelopes. The therapist will open the envelope and will find the treatment protocol to be conducted in this patient. Staff responsible for recruitment and outcome assessor is not allowed to receive information about the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: November 18, 2023
• Study Start: January 18, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 20, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

SA (1)