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NCT06178042

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

Completed NA Last updated 20 December 2023
What this trial tests

NA trial testing MI Paste Plus in White Spot Lesion in 39 participants. Completed in 25 May 2022.

Timeline
1 February 2020
Primary endpoint
1 February 2022
25 May 2022

Quick facts

Lead sponsorIzmir Katip Celebi University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment39
Start date1 February 2020
Primary completion1 February 2022
Estimated completion25 May 2022
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Izmir Katip Celebi University

Who can join

Adults 12 to 25, any sex, with White Spot Lesion or Remineralization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for White Spot Lesion

Currently open trials in the same condition.

Other Izmir Katip Celebi University trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing