White Spot Lesions Treatment in Orthodontic (WSL)
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ClinicalTrials.gov Identifier: NCT06051981 |
Recruitment Status :
Not yet recruiting
First Posted : September 25, 2023
Last Update Posted : September 25, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
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White Spot Lesion | Drug: 5% sodium fluoride Drug: Intensive 5% sodium fluoride Drug: Casein Phosphopeptide-Amorphous Calcium Phosphate Drug: Resin infiltration | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 88 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. At 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. |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
Official Title: | 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 |
Estimated Study Start Date : | October 2023 |
Estimated Primary Completion Date : | February 2024 |
Estimated Study Completion Date : | March 2024 |
Arm | Intervention/treatment |
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Experimental: Fluoride Varnish (control)
The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. In group I, FV EnamelastTM will be applied to all teeth using compressed air and cotton rolls, leaving them to dry for one minute. Patients will be advised to avoid eating, drinking, or brushing for 3-4 hours after application.
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Drug: 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.
Other Name: FV EnamelastTM |
Experimental: Intensive Fluoride Varnish
The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Patients in group II Intensive FV will be applied three times a week for a week (every two days).
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Drug: Intensive 5% sodium fluoride
Intensive FV will be applied three times a week for a week (every two days).
Other Name: EnamelastTM |
Experimental: Casein Phosphopeptide-Amorphous Calcium Phosphate
The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Group III (CPP-ACP) uses Tooth Mousse® for 12 weeks, will be applied after daily brushing with traditional toothpaste, left intact for 180 seconds, and rinsed with distilled water.
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Drug: 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
Other Name: (CPP-ACP), Tooth Mousse® (MI Paste®) (GC Corporation, Tokyo, Japan) |
Experimental: Resin Infiltration
The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Group IV uses ICON® resin infiltration, applying a 15% hydrochloric acid solution, rinsing with water, drying, and applying ICON-Dry. Excess resin is removed, and a light curing process is performed. The roughened enamel surface is polished using composite resin polish discs and cups.
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Drug: Resin infiltration
resin infiltration will be applied as specified by the manufacturer.
Other Name: ICON® (DMG, Hamburg, Germany) |
- Change in mineral contents of enamel [ Time Frame: Baseline pre-treatment (T1), immediately post-treatment (T2), and three months post-treatment (T3) ]The maximum light fluorescence value for each tooth with a white spot lesion will be determined using a DIAGNODent flat tip, following manufacturer's instructions. The DIAGNOdent scale will be used to measure the mineral content of enamel, with values ranging from 0 to 20.
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Post orthodontic patients with one WSLs on buccal surface of tooth with ICDAS Code 1 or 2.
- Agreeing to participate in the study by singing the study informed consent.
- For younger patients parents agree to provide consent for child participation in the study.
Exclusion Criteria:
- Developmental defects of dental hard tissue
- Patients who have systemic disease or under medications that usually cause an increased risk of oral caries.
- Patients who are allergic to Fluoride varnish, CPP-ACP and resin infiltration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051981
Contact: Samira Algasn, BDS | 966500929996 | samira.m.algasn2021@student.riyadh.edu.sa |
Principal Investigator: | Samira Algasn, BDS | Riyadh Elm University |
Publications of Results:
Other Publications:
Responsible Party: | Samira Fawaz M Algasn, Postgraduate Student, Riyadh Elm University |
ClinicalTrials.gov Identifier: | NCT06051981 |
Other Study ID Numbers: |
FPGRP/2023/780 |
First Posted: | September 25, 2023 Key Record Dates |
Last Update Posted: | September 25, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Fixed orthodontic Appliances White Spot Lesion Fluoride Varnish |
Casein Phosphopeptide-Amorphous Calcium Phosphate Resin Infiltration Laser Fluorescence |
Exanthema Skin Diseases Listerine Calcium Fluorides Sodium Fluoride Caseins Calcium-Regulating Hormones and Agents |
Physiological Effects of Drugs Cariostatic Agents Protective Agents Anti-Infective Agents, Local Anti-Infective Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |