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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06051981
Other study ID # FPGRP/2023/780
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date October 2023
Est. completion date March 2024

Study information

Verified date September 2023
Source Riyadh Elm University
Contact Samira Algasn, BDS
Phone ?966500929996?
Email samira.m.algasn2021@student.riyadh.edu.sa
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.
Intensive 5% sodium fluoride
Intensive FV will be applied three times a week for a week (every two days).
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
Resin infiltration
resin infiltration will be applied as specified by the manufacturer.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Riyadh Elm University

References & Publications (13)

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Outcome

Type Measure Description Time frame Safety issue
Primary Change in mineral contents of enamel 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. Baseline pre-treatment (T1), immediately post-treatment (T2), and three months post-treatment (T3)
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