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Effectiveness of MI Paste Plus and Remin Pro on Remineralization of Post-Orthodontic White Spot Lesions

NCT06178042 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-12-20

No results posted yet for this study

Summary

One of the most undesired side effects of fixed orthodontic treatment is white spot lesions (WSLs), that appear on the buccal surface of teeth and cause aesthetic problems. The aim of this prospective study was to quantitively evaluate the remineralization effect of casein phosphopeptide-amorphous calcium fluorophosphate (CPP-ACFP) containing (MI Paste Plus®) and hydroxyapatite, xylitol and fluoride containing (Remin Pro®) agents in remineralizing post orthodontics white spots using Quantitive Light-Induced Fluorescence Method (QLF) and ICDAS II criteria, compared to a control group in whom just a routine home care was instructed. Thirty-nine individuals who had recently completed orthodontic treatment, had at least one WSL on upper anterior teeth and aged between 12-25 years were included. The participants were randomly assigned into three groups of 13 each; (1) MI Paste Plus + routine home care; (2) Remin Pro + routine home care; and (3) routine home care (control). The treatment/ observation period was 12 weeks after bracket debonding. Fluorescence loss (∆F, %), lesion area (LA, mm2), lesion volume (∆Q, % × mm2), maximum fluorescence loss (∆Fmax), ICDAS II criteria of WSLs were measured at beginning (T0) and 4 (T1), 8 (T2), and 12 (T3) weeks later. Statistical significance was set at p\<0.05.

Conditions

  • White Spot Lesion
  • Remineralization

Interventions

COMBINATION_PRODUCT

MI Paste Plus

Briefly, a pea-sized amount of the cream was used once a day and was allowed to remain on the teeth for three minutes after conventional tooth brushing. Patient was advised to not to spit out the cream for 30 seconds to activate the product with saliva. Patient was advised to spit out the remaining amount to avoid swallowing excessive fluoride and to wait for 30 minutes after the treatment before rinsing or eating or drinking.

COMBINATION_PRODUCT

Remin Pro

The cream must remain on the teeth for at least three minutes once daily after conventional tooth brushing. Patient was advised to spit out the remaining amount to avoid swallowing excessive fluoride and to wait for 30 minutes after the treatment before rinsing or eating or drinking.

COMBINATION_PRODUCT

Control

Patients instructed to follow a routine home care.

Sponsors & Collaborators

  • Izmir Katip Celebi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2022-02-01
Completion
2022-05-25

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06178042 on ClinicalTrials.gov