Clinical trial NCT06140277: Using Of Chitosan in Alveolar Ridge Preservation
Official title: Using Of Chitosan in Alveolar Ridge Preservation: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Tooth Extraction Status Nos
Bone Augmentation
Keywords: chitosan
socket preservation
Lead sponsor: Prince Sattam Bin Abdulaziz University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone Hight
timeFrame: 3 months
measure: Bone volume
timeFrame: 3 months
Secondary outcomes:
measure: Tissue healing
timeFrame: 3 months
measure: Dry socket
timeFrame: 3 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Prince Sattam Bin Abdulaziz University
state: Central
Study officials:
References: