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IRCT20190803044423N1 IRCT 2019-09-15 Zahedan University of Medical Sciences Evaluation of the effect of Protact mouthwash (Zataria Multilflora extract) on Candida Albicans and gingival indexes in patients undergoing fixed orthodontic treatment Evaluation of the comparative effect of Protact mouthwash (Zataria Multilflora extract) and chlorhexidine on Candida Albicans and gingival indexes in patients undergoing fixed orthodontic treatment 2019-09-23 anticipated 60 Complete https://irct.ir/trial/41253 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization method is simple random allocation. In such a way, the required number of cards in each study group labeled A, B, and C is placed in a bag. Upon referral, a eligible case is asked to take one of the cards. Card A will be in the control group (placebo), card B will be in the Protact mouthwash (Zataria Multilflora extract) group and card C will be in the chlorhexidine group, Blinding description: The mouthwashes as well as the physiological saline, as placebo, are provided in similar plastic containers with same size, so that the patient and the researcher will not be aware of the type of mouthwash. 3 Candida albicans number of fungi,gingival index. Intervention 1: Control group: placebo physiological saline. Intervention 2: Intervention group: protact mouthwash(zataria mutiflora). Intervention 3: Intervention group: Chlorhexidine Mouthwash 0.12%. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Bahareh Fatemipour
Balouchestan Blvd.Zahedan University Medical Science
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5744 drfatemib@gmail.com Zahedan University of Medical Sciences scientific Bahareh Fatemipour
Balouchestan Blvd.Zahedan University of Medical Science
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5744 drfatemib@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Patients undergoing fixed orthodontic treatment (including brackets on the anterior and premolars and band on first molar) At least three to five months after orthodontic treatment Proper oral hygiene 13 years 30 years Both Existence of immune insufficient disease or systemic diseases The presence of severe rotation and malposition teeth Existence of periodontitis Existence of active dental caries Smoking and substance use Taking any antibiotics and antifungal medication for several days before starting the study and during the study period Pregnancy and lactation Sensitivity to mouthwash Use of mouthwash in the past month Not using the recommended health protocol during the study Do not use mouthwash as instructed during the study period Placebo Treatment - Drugs Treatment - Drugs Control group: placebo physiological saline Intervention group: protact mouthwash(zataria mutiflora) Intervention group: Chlorhexidine Mouthwash 0.12% Candida albicans number of fungi. Timepoint: At baseline (3 to 6 months after orthodontic treatment) and 21 days after intervention. Method of measurement: Swab specimen culture from cervical enamel of second premolars and central incisors of both mandibles adjacent to brackets. Modified gingival index (MGI). Timepoint: At baseline (3 to 6 months after orthodontic treatment) and 21 days after intervention. Method of measurement: The labial/facial surfaces of the gingiva and the interdental papillae of the desired teeth are examined and rated for inflammation from zero (no inflammation) to 4 (severe inflammation). Gingival bleeding Index (BI). Timepoint: At baseline (3 to 6 months after orthodontic treatment) and 21 days after intervention. Method of measurement: The probe is carefully inserted into the pocket of the desired tooth, gently moving sideways to the wall of the pocket, and scored based on its bleeding time. In case of no bleeding within 30 seconds, score is zero, in case of bleeding within 30 seconds, score is 1 and in case of immediate bleeding, score is 2. Zahedan University of Medical Sciences Approved 2019-07-28 Ethics Committee of Zahedan University of Medical Sciences Balouchestan Blvd.Zahedan University of Medical science.9816743463 ZAHEDAN Sistan-va-Balouchestan Iran (Islamic Republic of)