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IRCT20220219054065N1 IRCT 2022-02-24 Shiraz University of Medical Sciences Evaluation of the anti-cariogenic effect of chitosan–nano amorphous calcium phosphate and chitosan-nano hydroxyapatite varnish Evaluation of the anti-cariogenic effect of chitosan–nano amorphous calcium phosphate and chitosan-nano hydroxyapatite varnish around orthodontic brackets; A Randomized clinical trial 2022-02-28 anticipated 120 Complete https://irct.ir/trial/62051 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: All the participants will be randomized using a 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 eight.The group allocation will be carried out by an assistant not directly involved in the study only after each patient will be seated for the initial bonding appointment, and a random numerical code will be assigned to each patient at the beginning of the study based on the randomization list created before. Groups I, II, III and IV will include subjects using CMC/ACP, CMC/HA , fluoride and placebo varnish respectively, Blinding description: The patients, therapists, and the data assessors will be blinded to the type of varnish used. In this regard, the varnish bottles’ shapes will be similar and labeled as A, B and C and D randomly by a person not involved in this study. 3 Dental caries. Intervention 1: First group : Chitosan-nano hydroxyapatite. CMC will be prepared by Hangzhou New Asia Intrernational Co.,Ltd,China ). HA ( Ca10(Po4) 6(OH)2 , white powder , size of nano particles < 50 nm ) will be prepared by Tamadkala (Tehran,Iran,Arminano brand). The varnish base will be prepared by mixing hydrogenerated rosin with absolute ethanol at a 3:1 (W/W) ratio in a closed vessel on a stirrer at room temperature for 24hours. 5% (W% ) chitosan and 10 % (W%) nano-HA will be added to the varnish base (hydrogenerated rosin (50% W) with absolute ethanol (35% W) ) for CMC/nano-HA varnish production. Varnish application will be done at the first session and then every 3 month untill the end of the treatment. Intervention 2: Second group: Chitosan-nano Amorphous calcium phosphate. CMC will be prepared by Hangzhou New Asia Intrernational Co.,Ltd,China ). Nano Amorphous calcium phosphate will be prepared by Dr.Atai(Iran Polymer and Petrochemical institute. Tehran Province, Tehran). The varnish base will be prepared by mixing hydrogenerated rosin with absolute ethanol at a 3:1 (W/W) ratio in a closed vessel on a stirrer at room temperature for 24hours. 5% (W%) chitosan and 10 % (W%) nano-ACP will be added to the varnish base (hydrogenerated rosin (50% W) with absolute ethanol (35% W) ) for CMC /nano-ACP varnish production. Varnish application will be done at the first session and then every 3 month untill the end of the treatment. Intervention 3: Third group: Flouride Varnish. 5% Ariadent floride varnish will be prepared by Asia chemiTeb Co.(Tehran , Iran). Intervention 4: Control group: Placebo Varnish. Yes - There is a plan to make this available What will be shared: part of data such as information about the main outcome can be shared When: start of access 6 months after publishing of the results To whom: our data will be accessbile only to higher education researchers. Conditions: if data needs authentication for further studies, writers will be accessible. Where to obtain: for further information , please contact Shiraz University of Medical Science (SUMS) , please. How to obtain: further questions will be responded at library.sums.ac.ir Comments:
public Hooman Zarif Najafi
Ghom abad street, Ghasrodasht blv. dental university of Shiraz
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3626 3193 Zarif_Hooman@gmail.com Shiraz University of Medical Sciences scientific Hooman Zarif Najafi
Ghom abad street, Ghasrodasht blv. dental university of Shiraz
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3626 3193 Zarif_Hooman@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients aged 14-29 years old who require fixed orthodontic therapy All maxillary permanent teeth present up to at least first molars Good overall health Good oral hygiene ( with plaque score ≤20% ) No visible discontinuous band of plaque at the gingival margin of teeth and no bleeding on probing after 30 seconds Normal stimulated salivary flow rate (>1.0 mL /min) and buffer capacity ( a final pH of 6.0 and 7.0) 14 years 29 years Both History of any previous orthodontic treatments or extractions History of using any bleaching agents or topical fluoridation within the last six months Non-observence of oral hygiene instructions Sever crowding of >6mm or severely rotated teeth , necessitating extraction of teeth Blocked out teeth and high buccal teeth that ristricts the patient hygienic access also put limitation for vissual and diagnodent examinations Any dental morphologic anomaly,intrinsic or extremly heavy extrinsic staining Visible signs of caries or fluorosis or hypocalcification and also any developmental defects Existence of dental crowns, amalgam or composite restorations which extended to buccal surface of teeth Any systemic or endocrine problems ( such as diabetes or cardiovascular diseases), craniofacial anomalies and lip or palatal clefts and smoking habits Any WSLs present on qualified teeth with and without frank cavitation, 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 Prevention Prevention Prevention Placebo First group : Chitosan-nano hydroxyapatite. CMC will be prepared by Hangzhou New Asia Intrernational Co.,Ltd,China ). HA ( Ca10(Po4) 6(OH)2 , white powder , size of nano particles < 50 nm ) will be prepared by Tamadkala (Tehran,Iran,Arminano brand). The varnish base will be prepared by mixing hydrogenerated rosin with absolute ethanol at a 3:1 (W/W) ratio in a closed vessel on a stirrer at room temperature for 24hours. 5% (W% ) chitosan and 10 % (W%) nano-HA will be added to the varnish base (hydrogenerated rosin (50% W) with absolute ethanol (35% W) ) for CMC/nano-HA varnish production. Varnish application will be done at the first session and then every 3 month untill the end of the treatment. Second group: Chitosan-nano Amorphous calcium phosphate. CMC will be prepared by Hangzhou New Asia Intrernational Co.,Ltd,China ). Nano Amorphous calcium phosphate will be prepared by Dr.Atai(Iran Polymer and Petrochemical institute. Tehran Province, Tehran). The varnish base will be prepared by mixing hydrogenerated rosin with absolute ethanol at a 3:1 (W/W) ratio in a closed vessel on a stirrer at room temperature for 24hours. 5% (W%) chitosan and 10 % (W%) nano-ACP will be added to the varnish base (hydrogenerated rosin (50% W) with absolute ethanol (35% W) ) for CMC /nano-ACP varnish production. Varnish application will be done at the first session and then every 3 month untill the end of the treatment. Third group: Flouride Varnish. 5% Ariadent floride varnish will be prepared by Asia chemiTeb Co.(Tehran , Iran). Control group: Placebo Varnish Fluorescence assessment. Timepoint: every 3 months. Method of measurement: The teeth will be scanned carefully by the same dentist blinded as to group allocation of the subjects using probe tip B held in contact with the tooth surface and tilted around the measuring site rocking slowly in a pendulous motion so that fluorescence can be collected from all directions at 4 labial sites on the enamel (gingival, occlusal, mesial, and distal) around the brackets.The peak reading displayed on the panel of the DIAGNOdent pen during the scan will be recorded for each site of tooth surface. Then the mean of 4 sites for each tooth will be calculated and recorded. For each patient the mean scores of all 10 maxillary teeth that are included in the study will be calculated and a mean DD reading number for each patient will be recorded. Visual assessment of WSL ( Gorelick assessment). Timepoint: every 3 months. Method of measurement: Before applying varnish at baseline(T0) ,3 months(T1), 6 months(T2) , 9 months(T3) and 12 months (T4) and at the end of the treatment(T5) , three standardized intraoral photographs (one frontal and two laterals) will be taken by a commercial SLR camera Nikon D5300 (Nikon Corporation, Tokyo, Japan) outfitted with a 24 to 85 mm macro lens and an SB29s Macro Speedlight from patients in natural head position after cleaning and drying the teeth as mentioned above. Then, the photographs will be stored on a USB device, the cropped and color-matched before-and-after images for each patient will be imported into a Power- Point (Microsoft, Redmond, Wash) slide with a black background and the presence and severity of white spot lesions will be evaluated independently by two orthodontics specialists who are blinded with regard to the treatment group each patient belongs to. The labial surfaces of the maxillary incisors, cuspids and premolars will be assessed according to Gorelick et al.: Score 1 = no white spot formation; Score 2 = slight white spot formation (thin rim); Score 3 = excessive white spot formation (thicker bands); and Score 4 = white spot formation with cavitation. Shiraz University of Medical Sciences Approved 2022-02-15 Ethics committee of Shiraz University of Medical Sciences Unit9, Floor 3, Kuhsar Mahdi hwy, Ghasrodasht blv. Shiraz Fars Iran (Islamic Republic of)