Protocol summary
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Study aim
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To evaluate the remineralizing effect of 10% xylitol varnish compared to 5% fluoride varnish and routine dental care on white spot lesions formed after fixed orthodontic treatment.
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Design
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Clinical randomized trial of 84 patients with three-arm parallel group (with 1: 1: 1 ratio) and triple-blind.
Block randomization list will be created by https://www.sealedenvelope.com with a block size of six.
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Settings and conduct
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Private office of Dr. Hooman Zarif Najafi
Clinician, patients and data analyzer will be blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients aged between 14 and 25 years old who had completed fixed orthodontic treatment recently with at least one WSL on the facial surface of eight maxillary anterior teeth.
Exclusion criteria: Patients with chronic disease; Any abnormal oral, medical, or mental condition; 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/developmental anomalies; Alterations of the enamel, e.g. hypoplasia, fluorosis; Chronic use of medication causing a dry mouth; Known pregnancy or breastfeeding; Professional administration or home use of highly concentrated fluoride productsduring the whole study.
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Intervention groups
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First intervention group: Xylitol 10% varnish
Second intervention group: Fluoride 5 % varnish
Control group: Placebo varnish
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Main outcome variables
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Enamel mineral content
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180913041032N2
Registration date:
2021-12-03, 1400/09/12
Registration timing:
prospective
Last update:
2024-12-09, 1403/09/19
Update count:
1
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Registration date
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2021-12-03, 1400/09/12
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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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2021-12-11, 1400/09/20
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Expected recruitment end date
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2022-05-10, 1401/02/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Treatment of post-orthodontic white spot lesions with 10% xylitol varnish: A randomized Clinical Trial
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Public title
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Effect of xylitol in treatment of post-orthodontic white spot lesions
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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.
Exclusion criteria:
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
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Age
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From 14 years old to 25 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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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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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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2021-07-14, 1400/04/23
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Ethics committee reference number
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IR.SUMS.DENTAL.REC.1400.048
Health conditions studied
1
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Description of health condition studied
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White spot lesions
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ICD-10 code
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K02.61
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ICD-10 code description
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Dental caries on smooth surface limited to enamel
Primary outcomes
1
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Description
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Enamel mineral content
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Timepoint
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Baseline, 6 and 12 month post orthodontic treatment
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Method of measurement
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DIAGNOdent pen
Secondary outcomes
1
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Description
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visual assessment of white spot lesions
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Timepoint
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baseline and 12 month post orthodontic treatment
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Method of measurement
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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.
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
3
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Description
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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.
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Category
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Placebo
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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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Data of primary and secondary outcomes are possible to be shared.
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When the data will become available and for how long
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The date of accessibility will be from the results publication.
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To whom data/document is available
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For whom interested
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Under which criteria data/document could be used
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No specific condition needed
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From where data/document is obtainable
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For receiving the documents, contact the following E-mail address:
shavakhi.m@gmail.com
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What processes are involved for a request to access data/document
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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.
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Comments
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