Protocol summary
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Study aim
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Evaluation of one type of varnish in preventing the formation of white spot lesions in patients under Orthodontic treatment
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Design
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Parallel group, Randomized clinical trial, Double-blind (patient and examiner), 72 patients, Using dynamic randomized block
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Settings and conduct
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On the day of treatment, the upper jaw's teeth will be dried and isolated, then varnish is applied to the buccal surface of the tooth with a micro brush, after one minute the patient is asked to spit, and this process is repeated every four weeks for 7 months. This process will be done in the orthodontics department of the dentistry school.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria::
۱. Age range of ۱۴ to ۲۹ years
۲. Absence of any systemic disease
۳. No use of antibiotics or antibacterial mouthwash in the previous month
۴. Periodontal health, absence of current caries or enamel demineralization
۵. All permanent dentition is present up to the first molar.
۶. No history of prior orthodontic or periodontal therapy.
۷. No smoking habit
Exclusion criteria
۱. Visible sign of dental hypo-calcification
۲. Craniofacial anomalies
۳. History of cleft lip and palate deformities
۴. History of dental restorative treatment on the buccal surface
۵. History of long term use of anti-inflammatory drugs
۶. History of glass ionomer dental restorative treatment
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Intervention groups
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Parallel groups, ranandomized clinincal trial
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Main outcome variables
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Caries assessment, Evaluation of bacterial count
General information
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Reason for update
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the trial is finished
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220907055913N1
Registration date:
2022-09-16, 1401/06/25
Registration timing:
prospective
Last update:
2025-03-01, 1403/12/11
Update count:
1
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Registration date
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2022-09-16, 1401/06/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-10-07, 1401/07/15
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Expected recruitment end date
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2023-05-05, 1402/02/15
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Actual recruitment start date
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2022-10-22, 1401/07/30
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Actual recruitment end date
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2022-11-20, 1401/08/29
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Trial completion date
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2023-07-01, 1402/04/10
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Scientific title
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Evaluation of the antibacterial and caries prevention effects of a varnish containing combined nanohydroxyapatite and galla chinensis in fixed orthodontic patients
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Public title
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Evaluation of caries control effect of a varnish containing combined nanohydroxyapatite and galla chinensis
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 14 years old to 29 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
72
Actual sample size reached:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-09-06, 1401/06/15
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Ethics committee reference number
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IR.SUMS.DENTAL.REC.1401.057
Health conditions studied
1
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Description of health condition studied
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dental caries
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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caries assessment(florescent and visual assesment)
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Timepoint
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Initial values (T۰) ,۱ months(T۱), ۴ months(T۲) , ۷ months(T۳) of use of various anti-demineralizing agents
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Method of measurement
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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.
Secondary outcomes
1
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Description
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bactreial colony count
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Timepoint
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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
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Method of measurement
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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.
Intervention groups
1
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Description
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Control group: Placebo Varnish
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Category
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Placebo
2
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Part of data such as information about the main outcome can be shared
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When the data will become available and for how long
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Start of access 6 months after publishing of the results
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To whom data/document is available
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Our data will be accessible only to higher education researchers.
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Under which criteria data/document could be used
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If data needs authentication for further studies, writers will be accessible
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From where data/document is obtainable
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For further information , please contact Shiraz University of Medical Science (SUMS) , please.
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What processes are involved for a request to access data/document
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Further questions will be responded at the library.sums.ac.ir
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Comments
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