Clinical trial
The Effect of Fluoride Varnish, Casein Phosphopeptide-Amorphous Calcium Phosphate, and Resin Infiltration in the Treatment of White Spot Lesions After Orthodontic Therapy: A Randomized Controlled Trial
Name
FPGRP/2023/780
Description
The study aims to investigate the effectiveness of a new treatment for demineralized white spot lesions (WSLs) after fixed appliance therapy. The trial will consist of four parallel groups: control, Fluoride Varnish (FV), Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP), and Resin Infiltration (RI) groups. Patients will be recruited from Riyadh Elm University's electronic record system and contacted by phone. They will be given an appointment to visit the dental clinic.
A total of 22 patients with WSLs will be selected for the study. Two examiners will perform dental examinations using a dental mirror and a ball-ended probe to code the WSL against the ICDAS system. The level of agreement between the two examiners will be assessed using reliability analysis, with an agreement level of above 80% considered.
Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial or distal surface. WSLs coded 3 or higher will be excluded from further examination and treated accordingly.
Trial arms
Trial start
2023-10-01
Estimated PCD
2024-02-01
Trial end
2024-03-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
5% sodium fluoride
a flavored xylitol-sweetened, 5% sodium fluoride in a resin carrier delivered in a 1.2 ml syringe or in a 0.4 ml unit, Ultradent, USA) will be applied on all teeth according to the manufacturer's instructions.
Arms:
Fluoride Varnish (control)
Other names:
FV EnamelastTM
Intensive 5% sodium fluoride
Intensive FV will be applied three times a week for a week (every two days).
Arms:
Intensive Fluoride Varnish
Other names:
EnamelastTM
Casein Phosphopeptide-Amorphous Calcium Phosphate
for 12 weeks. A thin layer from Tooth Mousse™ will be applied to the teeth after daily brushing with traditional toothpaste and left intact for 180 seconds before rinsing with distilled water
Arms:
Casein Phosphopeptide-Amorphous Calcium Phosphate
Other names:
(CPP-ACP), Tooth Mousse® (MI Paste®) (GC Corporation, Tokyo, Japan)
Resin infiltration
resin infiltration will be applied as specified by the manufacturer.
Arms:
Resin Infiltration
Other names:
ICON® (DMG, Hamburg, Germany)
Size
88
Primary endpoint
Change in mineral contents of enamel
Baseline pre-treatment (T1), immediately post-treatment (T2), and three months post-treatment (T3)
Eligibility criteria
Inclusion Criteria:
1. Post orthodontic patients with one WSLs on buccal surface of tooth with ICDAS Code 1 or 2.
2. Agreeing to participate in the study by singing the study informed consent.
3. For younger patients parents agree to provide consent for child participation in the study.
Exclusion Criteria:
1. Developmental defects of dental hard tissue
2. Patients who have systemic disease or under medications that usually cause an increased risk of oral caries.
3. Patients who are allergic to Fluoride varnish, CPP-ACP and resin infiltration.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Once the FV has been applied, the examiners at Riyadh Elm University will do a visual inspection and take LF measurements (T2) on all the areas that were marked as WSL on the initial photos. The LF measurement will be carried out by the same inspectors who carried out the visual inspection.\n\nAt the end of treatment for groups II, III, IV, a visual examination and LF measurements (T2) will be conducted by the same examiners. At the next inspection (after 3 months (T3)), LF measurements will be carried out on all areas that were marked as WSL on the original photos, whether they are still existing WSL areas or they will be changed to WSL free areas.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'A web based research randomizer software will be used to generate a random sequence number to allocate the participants to different groups. The allocation will be kept concealed from patients and examiners using sequentially numbered identical containers containing experimental materials (remineralizing agents) to ensure the double blindness of the study.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 88, 'type': 'ESTIMATED'}}
Updated at
2023-09-25
1 organization
Organization
Riyadh Elm University