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IRCT20180913041032N2 IRCT 2021-12-03 Shiraz University of Medical Sciences Effect of xylitol in treatment of post-orthodontic white spot lesions Treatment of post-orthodontic white spot lesions with 10% xylitol varnish: A randomized Clinical Trial 2021-12-11 anticipated 84 Complete https://irct.ir/trial/60125 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All the participants will be randomized using dynamic randomized block design for balancing age and sex. A block randomization list will be created by https://www.sealedenvelope.com with a block size of six. The group allocation will be revealed by an assistant not directly involved in the study and a random code number will be assigned to each patient based on the randomization list created at the beginning of study, Blinding description: The participating patients, the main therapist corresponding the varnish administration and evaluate the study outcome, the person who collect and analyses data and the persons prepares the results report will be blinded with respect to the type of varnish used. In this regard the placebo varnish will be specially manufactured by the Asia ChemiTeb Co with the same basic composition and viscosity as the commercial Ariadent fluoride varnish (Asia ChemiTeb Co., Tehran, Iran). All varnishes will be stored in similar tubes and will be labeled as A, B and C. 3 White spot lesions. Intervention 1: Intervention1: 5% fluoride varnish: Ariadent fluoride varnish (Asia ChemiTeb Co, Tehran, Iran). At the time of debonding, remaining composite material on the enamel surfaces will be removed with 12-bladed tungsten carbide bur and a low-speed hand piece followed by polishing with a rubber cup a fluoride-free pumice paste . The varnish will be applied with a small brush in a thin layer of the facial surface of the eight anterior maxillary teeth. After 60 s of setting, the patients will be instructed not to drink within 60 min, not to eat for 4 h, and brush their teeth until the next day morning. This process will be repeated every three months (4 times during study) after cleaning and drying the teeth. Intervention 2: Intervention 2: 10% xylitol varnish. Xylitol varnish will be especially manufactured by Asia ChemiTeb Co (Tehran, Iran) with the same basic composition as the commercial Ariadent fluoride varnish (Asia ChemiTeb Co, Tehran, Iran). At the time of debonding, remaining composite material on the enamel surfaces will be removed with 12-bladed tungsten carbide bur and a low-speed hand piece followed by polishing with a rubber cup a fluoride-free pumice paste . The varnish will be applied with a small brush in a thin layer of the facial surface of the eight anterior maxillary teeth. After 60 s of setting, the patients will be instructed not to drink within 60 min, not to eat for 4 h, and brush their teeth until the next day morning. This process will be repeated every three months (4 times during study) after cleaning and drying the teeth. Intervention 3: Control group: Placebo varnish, placebo varnish will be especially manufactured by Asia ChemiTeb Co (Tehran, Iran) with the same basic composition as the commercial Ariadent fluoride varnish (Asia ChemiTeb Co, Tehran, Iran). At the time of debonding, remaining composite material on the enamel surfaces will be removed with 12-bladed tungsten carbide bur and a low-speed hand piece followed by polishing with a rubber cup a fluoride-free pumice paste . The varnish will be applied with a small brush in a thin layer of the facial surface of the eight anterior maxillary teeth. After 60 s of setting, the patients will be instructed not to drink within 60 min, not to eat for 4 h, and brush their teeth until the next day morning. This process will be repeated every three months (4 times during study) after cleaning and drying the teeth. Yes - There is a plan to make this available What will be shared: Data of primary and secondary outcomes are possible to be shared. When: The date of accessibility will be from the results publication. To whom: For whom interested Conditions: No specific condition needed Where to obtain: For receiving the documents, contact the following E-mail address: shavakhi.m@gmail.com How to obtain: The request of getting the documents should be sent through an official email. The email contents include the name and position of the person receiving the data and the reason of requesting. After evaluation by corresponding author, the documents file will be sent within 1 to 2 weeks. Comments:
public Hooman Zarif Najafi
Shiraz dental school, Qom abad, Ghasrodasht St.
Shiraz Iran (Islamic Republic of) ۱۵۸۷۸- ۷۱۹۵۶ +98 71 3626 3193 zarifhooman@gmail.com Shiraz University of Medical Sciences scientific Mojgan Shavakhi
School of dentistry, Isfahan university of medical sciences, Sofe St.
اصفهان Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 shavakhi.m@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) The subjects will be chosen within patients aged between 14 and 25 years old who had completed fixed appliance orthodontic therapy recently. Have at least one WSL on the facial surface of eight maxillary anterior teeth that was not presented before orthodontic treatment. 14 years 25 years Both Patient’s unwillingness to be randomly assigned to one of the three treatment groups Ongoing medication for a chronic disease Chronic conditions such as asthma and allergy Any abnormal oral, medical, mental condition or neuropsychiatric disorders Regular use of oral antiseptics Any WSLs present on qualifying teeth with frank cavitation, Extensive restorations on the facial surfaces of the study teeth Dental morphologic, anatomical or developmental anomalies Alterations of the enamel, e.g. hypoplasia, fluorosis Chronic use of medication causing a dry mouth or known xerostomia Known pregnancy or breastfeeding during the course of the study Professional administration or home use of highly concentrated fluoride products not related to the study during the whole study K02.61 Dental caries on smooth surface limited to enamel Treatment - Drugs Treatment - Drugs Placebo Intervention1: 5% fluoride varnish: Ariadent fluoride varnish (Asia ChemiTeb Co, Tehran, Iran). At the time of debonding, remaining composite material on the enamel surfaces will be removed with 12-bladed tungsten carbide bur and a low-speed hand piece followed by polishing with a rubber cup a fluoride-free pumice paste . The varnish will be applied with a small brush in a thin layer of the facial surface of the eight anterior maxillary teeth. After 60 s of setting, the patients will be instructed not to drink within 60 min, not to eat for 4 h, and brush their teeth until the next day morning. This process will be repeated every three months (4 times during study) after cleaning and drying the teeth. Intervention 2: 10% xylitol varnish. Xylitol varnish will be especially manufactured by Asia ChemiTeb Co (Tehran, Iran) with the same basic composition as the commercial Ariadent fluoride varnish (Asia ChemiTeb Co, Tehran, Iran). At the time of debonding, remaining composite material on the enamel surfaces will be removed with 12-bladed tungsten carbide bur and a low-speed hand piece followed by polishing with a rubber cup a fluoride-free pumice paste . The varnish will be applied with a small brush in a thin layer of the facial surface of the eight anterior maxillary teeth. After 60 s of setting, the patients will be instructed not to drink within 60 min, not to eat for 4 h, and brush their teeth until the next day morning. This process will be repeated every three months (4 times during study) after cleaning and drying the teeth. Control group: Placebo varnish, placebo varnish will be especially manufactured by Asia ChemiTeb Co (Tehran, Iran) with the same basic composition as the commercial Ariadent fluoride varnish (Asia ChemiTeb Co, Tehran, Iran). At the time of debonding, remaining composite material on the enamel surfaces will be removed with 12-bladed tungsten carbide bur and a low-speed hand piece followed by polishing with a rubber cup a fluoride-free pumice paste . The varnish will be applied with a small brush in a thin layer of the facial surface of the eight anterior maxillary teeth. After 60 s of setting, the patients will be instructed not to drink within 60 min, not to eat for 4 h, and brush their teeth until the next day morning. This process will be repeated every three months (4 times during study) after cleaning and drying the teeth. Enamel mineral content. Timepoint: Baseline, 6 and 12 month post orthodontic treatment. Method of measurement: DIAGNOdent pen. Visual assessment of white spot lesions. Timepoint: baseline and 12 month post orthodontic treatment. Method of measurement: The labial surface of maxillary incisors, cuspids and premolars will be assessed according to Gorlick et al. score 1: no white spot lesion, score 2: slight white spot lesion (thin rim). score 3: excessive white spot lesion (thick band), and score 4: white spot lesion with cavitation. Shiraz University of Medical Sciences Approved 2021-07-14 Research Ethics Committees of School of Dentistry- Shiraz University of Medical Sciences School of Dentistry, Qom Abad, Ghasrodasht St Shiraz Fars Iran (Islamic Republic of)