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IRCT20180913041032N1 IRCT 2018-10-14 Shiraz University of Medical Sciences Effect of Xylitol Varnish in Caries Prevention Around Orthodontic Brackets Evaluation the Preventive Effect of Two Concentration of Xylitol Varnish vs Fluoride Varnish on Enamel Demineralization Around Orthodontic Brackets: A randomized controlled trial 2018-09-13 anticipated 120 Complete https://irct.ir/trial/34089 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Dynamic randomized block design for balancing age and sex with block size of 8 using online randomization, Blinding description: The patients, therapist and the data collector and analyzer will be blinded with respect to the type of varnish used. In this regard the varnish tubes will be labeled as A, B, C and D. 3 Demineralization around Orthodontic brackets.. Intervention 1: Intervention group 1: Xylitol varnish 10%. Intervention 2: Intervention group 2: Xylitol varnish 20 %. Intervention 3: Intervention group 3: Sodium fluoride varnish 5%. Intervention 4: Control group: Placebo varnish. 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 Sampling will be start before 1 January 2019.
public Mojgan Shavakhi
School of Dentistry, Ghasr o Dasht St
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3625 7449 shavakhi.m@gmail.com Shiraz University of Medical Sciences scientific Hooman Zarif Najafi
School of Dentistry, Ghasr o Dasht St
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3626 3193 zarifhooman@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with Class I malocclusion and complete permanent dentition up to the first molars. Good overall health and good oral hygiene (full mouth plaque score < 20 %); with no bleeding after 30 seconds or having a discontinuous band of plaque at the gingival margin. Normal salivary flow rate (>1.0 mL/min) and buffer capacity (final pH between 6.0 and 7.0). 13 years 17 years Both History of previous orthodontic treatment or extractions, bleaching or topical fluoridation. Severe crowding >6 mm, severely rotated teeth. Visible sign of caries, fluorosis, hypocalcification or developmental defects. Dental crowns, amalgam or composite filling which extended to the buccal surface. Systemic or endocrine condition (such as cardiac pacemakers or diabetes mellitus). Craniofacial anomalies and clefts Smokers. Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Xylitol varnish 10% Intervention group 2: Xylitol varnish 20 % Intervention group 3: Sodium fluoride varnish 5% Control group: Placebo varnish Mean Diagnodent number. Timepoint: Before starting intervention, 3 and 6 months later and at the end of orthodontic treatment. Method of measurement: Diagnodent pen 2190. Visual assessment of white spot lesions. Timepoint: At the end of orthodontic treatment. Method of measurement: With the Gorelick index. Assessment of patients satisfaction of varnish therapy. Timepoint: After varnish therapy for patient. Method of measurement: Satisfaction questionnaire with binary (Yes/No) design. Shiraz University of Medical Sciences Approved 2018-09-12 Ethics committee of Shiraz University of Medical Sciences School of Dentistry, Ghasr o Dasht St shiraz Fars Iran (Islamic Republic of)