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IRCT20220907055913N1 IRCT 2022-09-16 Shiraz University of Medical Sciences Evaluation of caries control effect of a varnish containing combined nanohydroxyapatite and galla chinensis Evaluation of the antibacterial and caries prevention effects of a varnish containing combined nanohydroxyapatite and galla chinensis in fixed orthodontic patients 2022-10-07 anticipated 72 Complete https://irct.ir/trial/65811 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: To balance the age and sex variables, the randomization will be done using block randomization for all participants. https://www.sealedenvelope.com will generate a block randomization list with a ۴-block size. T During the initial bonding appointment, a random code will be given to each patient based on the randomization list by an assistant who is not directly involved in the study. Groups I and II will include subjects using GCE/n-HA varnish (test) and placebo varnish (negative control) respectivel, Blinding description: The patients and orthodontist will be blinded to the type of varnish used. In this regard, the varnish bottles’ shapes will be similar and labeled as 1 and 2 by a person not involved in this study. 3 dental caries. Intervention 1: Control group: Placebo Varnish. Intervention 2: Intervention group: varnish combined galla chinensis(GCE) and nano hydroxyapatite(HA). HA ( Ca10(Po4) 6(OH)2 , white powder , size of nano particles < 20 nm ) will be prepared by APATECH (Yazd, Yazd Science and Technology park, Iran). 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. 4000 ppm of galla chinensis and 10 % (W%) nano-HA will be added to the varnish base (hydrogenerated rosin (50% W) with absolute ethanol (35% W) ) for GCE/nano-HA varnish production. Varnish application will be done at the first session and then every month untill 7 month. 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 accessible 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 the library.sums.ac.ir Comments:
public Shabnam Ajami
Orthodontic department, School of Dentistry, Qom Abad, Qasrodasht Ave
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3626 3193 dr.ajami.sh@gmail.com Shiraz University of Medical Sciences scientific Shabnam Ajami
Orthodontic department, School of Dentistry, Qom Abad, Qasrodasht Ave
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3626 3193 dr.ajami.sh@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) The age range of 14 to 29 years Absence of any systemic disease Periodontal health, absence of current caries or enamel demineralization. All permanent dentition is present up to the first molar No history of prior orthodontic or periodontal therapy No smoking habit No use of antibiotics or antibacterial mouthwash in the previous month 14 years 29 years Both Visible sign of dental hypo-calcification Craniofacial anomalies History of cleft lip and palate deformities History of dental restorative treatment on the buccal surface History of long term use of anti-inflammatory drugs History of glass ionomer dental restorative treatment Placebo Prevention Control group: Placebo Varnish Intervention group: varnish combined galla chinensis(GCE) and nano hydroxyapatite(HA). HA ( Ca10(Po4) 6(OH)2 , white powder , size of nano particles < 20 nm ) will be prepared by APATECH (Yazd, Yazd Science and Technology park, Iran). 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. 4000 ppm of galla chinensis and 10 % (W%) nano-HA will be added to the varnish base (hydrogenerated rosin (50% W) with absolute ethanol (35% W) ) for GCE/nano-HA varnish production. Varnish application will be done at the first session and then every month untill 7 month. Caries assessment(florescent and visual assesment). Timepoint: Initial values (T۰) ,۱ months(T۱), ۴ months(T۲) , ۷ months(T۳) of use of various anti-demineralizing agents. Method of measurement: 1. Visual assessment: All measures will be taken by the same examiner, who is calibrated before the research. Before bonding, the initial visual assessment will be done. The international caries detection and assessment system II (ICDAS II) will be used to inspect and record the buccal surfaces of the test subjects' teeth at each visit. After ۵ seconds of compressed air drying on the tooth surfaces, the examination will be done. The evaluation will be conducted with the use of a mouth mirror and a blunt probe under clinical illumination in accordance with the ICDAS II index criteria. The mean scores of all ۱۰ maxillary teeth involved in the research will be computed for each patient, and a mean reading number will be recorded. 2. Florescent assessment: 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 the 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 included in the study will be calculated and a mean Diagnodent reading number for each patient will be recorded. Bactreial colony count. Timepoint: plaque sampling and bacterial culturing will be done at the following time intervals: Initial values (T0) ,1 months(T1), 4 months(T2) , 7 months(T3) of use of various anti-demineralizing agents. Method of measurement: On the day of the appointment, the patient will be refrained from eating or brushing their teeth. Ligatures and archwires will be carefully removed at each appointment. The collecting sites will be gently air dried after being isolated of the excess water and saliva with cotton rolls. Plaque samples will be collected using a sterile cotton swab from the labial surfaces of the considered teeth.By moving the tip of the sterile cotton swab along the occlusal, mesial, gingival, and distal edges of the bracket base, and while holding the tip in constant contact with the tooth surface adjacent to the base of bracket, dental plaque will be collected. Sterile cotton swabs will be rapidly transferred to the samples transport media (thioglycolate broth carrier medium) and to anaerobic bacteria culture media. Microbial samples will be cultivated and analyzed by the same examiner in the Department of Clinical Microbiology of Shiraz University of Medical Sciences. According to G. WESTERGREN AND B. KRASSE, the sample will be cultured. Shiraz University of Medical Sciences Approved 2022-09-06 Ethics committee of Shiraz University of Medical Sciences Unit9, Floor 3, Kuhsar Mahdi hwy, Ghasrodasht blv. Shiraz Fars Iran (Islamic Republic of)