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IRCT20191127045516N4 IRCT 2021-01-11 Kermanshah University of Medical Sciences The effect of Chitosan biodegradable scaffold in prevention of extracted tooth dry socket Evaluation of the effect of Chitosan biodegradable scaffold in prevention of alveolar osteitis 2021-01-20 anticipated 176 Complete https://irct.ir/trial/52953 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The subjects will be divided into two equal groups by using the blocked randomization method and considering the number of samples required from the sample size formula. The process is done using block sizes of 6 and 8. Blocking will already be done by randomization online software, Blinding description: The list of specified intervention groups in this process remains by the coordinator. The dentist who is responsible for assessing the inclusion/exclusion criteria and registration of people will not know about this process. There is a closed envelope for each patient that was located a random 4-digit numerical code on each envelope determines which group the patient is in. Whether each code is specific to what group is written inside a table that was written by someone who have not participated in the process of study. This study is a double-blind clinical trial (in which patients and a statistician have been blinded). 3 Alveolar osteitis. Intervention 1: Intervention group: Chitosan biodegradable scaffold is placed in the sockets of the extracted teeth after surgery. (The process of making scaffold is done by using chitosan polymer which is biodegradable. The Chitosan is prepared by Chitin deacetylase.). Intervention 2: Control group: Routine treatment without the use of Chitosan biodegradable scaffold is done. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information available
public Hamed Nazari
School of Dentistry, Shariati St.
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3729 6591 hamed.nazari@kums.ac.ir Kermanshah University of Medical Sciences scientific Hamed Nazari
School of Dentistry, Shariati St.
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3729 6591 hamed.nazari@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Patients in need of surgical extraction of the mandibular third molar who refer to oral surgery department of Kermanshah dental school Patients with risk factors for alveolar osteitis (history of pericoronitis, smoking, use of OCPs, history of alveolar osteitis) 18 years no limit Both Surgical complications in surgeon's opinion Antibiotic therapy regimen Patients' unwillingness to cooperate with the trial Loss to follow up K10.3 Alveolitis of jaws Prevention N/A Intervention group: Chitosan biodegradable scaffold is placed in the sockets of the extracted teeth after surgery. (The process of making scaffold is done by using chitosan polymer which is biodegradable. The Chitosan is prepared by Chitin deacetylase.) Control group: Routine treatment without the use of Chitosan biodegradable scaffold is done. Incidence of alveolar osteitis after surgical extraction of mandibular impacted third molars. Timepoint: 3rd and 7th days after surgery. Method of measurement: Clinical diagnosis of alveolar osteitis by an experienced oral and maxillofacial surgeon regarding the signs and symptoms including: uncontrollable pain with analgesics between the first and third days to the week after tooth extraction with one or a combination of these signs: absence or insufficient blood clot in the socket, Detritus, exposed alveolar bone with or without halitosis. Pain intensity after surgery. Timepoint: 3rd and 7th days after surgery. Method of measurement: Using Visual Analogue Scale (VAS). Kermanshah University of Medical Sciences Approved 2020-12-22 Committee of Ethics in Research - Kermanshah University of Medical Sciences Committee of Ethics in Research, Vice chancellor for research and technology, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd. Kermanshah Kermanshah Iran (Islamic Republic of)