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IRCT20181203041837N1 IRCT 2020-02-26 Islamic Azad University Effect of chlorhexidine-releasing elastomerics on Streptococcus mutans Levels in orthodontic patients Saliva effect of chlorhexidine-releasing elastomerics on Streptococcus mutans Levels in orthodontic patients Saliva 2019-05-02 anticipated 15 Complete https://irct.ir/trial/35726 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, patients in need of fixed orthodontic treatment referring to dental clinic were randomly divided into two groups of intervention and control by a non-researcher. Individuals were divided into two groups of 15 individuals, each numbered from 1 to 30, and then randomly divided into two groups using random allocation software. Information about each individual was stored in numbered envelopes that were similar in appearance, Blinding description: The study is a double blind study. Chlorhexidine-releasing elastomerics and conventional elastomerics were quite similar in appearance and color. Patients received their elastomeric according to the assigned number. Patients were completely unaware of the elastomeric type. Saliva samples were given to microbiologists in similar containers. The microbiologist and the statistical analyzer were unaware of what elastomeric each patient used. 3 dental caries. Intervention 1: Intervention group: Orthodontic elastomers using the combination of chlorhexidine diacetate as an antibacterial agent and ethyl cellulose as the polymer. The volume of polymer used was 2%. Chlorhexidine-releasing elastomeric ligatures were used twice at baseline and 28 days after baseline study. Intervention 2: Control group: conventional elastomeric ligatures were. Yes - There is a plan to make this available What will be shared: File of Intervention program protocol and Statistical analysis plan through the publication of the thesis or writing an article When: Starting 6 months after publication of results. To whom: Research team of this study and other clinical academic researchers who are studying in favor of these patients Conditions: Researchers who intend to write a meta-analysis or systematic review articles are allowed to access documents Where to obtain: Dr. Somayeh Mehrabi (somaye.mehrabi@gmail.com) How to obtain: The request will be responsed after getting the approval of university or the Academic Institution Comments:
public Somayeh Mehrabi Koushki
No. 28 Nasr St. Valieasr Sq.
Tehran Iran (Islamic Republic of) ۸۱۵۵۱-۳۹۹۹۸ +98 21 8880 1760 somaye.mehrabi@gmail.com Islamic Azad University scientific Somayeh Mehrabi Koushki
No. 28 Nasr St. Valieasr Sq.
Tehran Iran (Islamic Republic of) ۸۱۵۵۱-۳۹۹۹۸ +98 21 8880 1760 somaye.mehrabi@gmail.com Islamic Azad University Iran (Islamic Republic of) Patients with fixed orthodontic treatment 12 years no limit Both existence of any systemic disease, Use antibiotics and other medication within two weeks before starting the study existence prosthodontic appliances, existence soft tissue lesions existence rampant caries K02.9 Dental caries, unspecified Prevention Placebo Intervention group: Orthodontic elastomers using the combination of chlorhexidine diacetate as an antibacterial agent and ethyl cellulose as the polymer. The volume of polymer used was 2%. Chlorhexidine-releasing elastomeric ligatures were used twice at baseline and 28 days after baseline study. Control group: conventional elastomeric ligatures were Colony Forming Unit (CFU) of Streptococcus mutans in saliva. Timepoint: baseline, and 7, 14, 21 and 28 days after the intervention. Method of measurement: Saliva sample collection for culture. Dental school Approved 2018-12-12 Ethics committee of School of Dentistry, Islamic Azad University, Isfahan (Khorasgan) Branch Islamic Azad University,Khorasgan Branch University Blvd, Arqavanieh, Jey Street Isfahan,Iran Isfahan Isfehan Iran (Islamic Republic of)