A Phase 2 interventional study of extraction with chitosan particles as a replacement for bone graft with collagen membrane and extraction with placing of allograft particles with collagen membrane in Tooth Extraction Status Nos and Bone Augmentation, sponsored by Prince Sattam Bin Abdulaziz University. Active, not recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Prince Sattam Bin Abdulaziz University · Phase 2, Interventional, and Treatment
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.
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.
Prince Sattam Bin Abdulaziz University is the lead sponsor of 34 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
the extraction will be done without placing any bone material inside
Procedure: tooth extraction only
to replace the bone at the extraction site we will put either chitosan or allograft particles
Also known as: chitosan
to replace the bone at the extraction site we will put allograft particles
Also known as: gold standard treatment
hopeless tooth will be extracted without any intervention
Also known as: normal extraction
Bone Hight
Changes in vertical dimension in mm from baseline using scans section from CBCT.
Time frame: 3 months
Bone volume
Changes in horizontal width in mm from baseline using scans section from CBCT.
Time frame: 3 months
Tissue healing
changes in scale of redness of gingiva from baseline
Time frame: 3 months
Dry socket
the No of exposed bone from baseline until healing
Time frame: 3 months
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Prince Sattam Bin Abdulaziz University