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

NCT06178042 | Completed

• 1 other identifier: SPEYNIRCI
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

White Spot Lesion; Remineralization; QLF; ICDAS II

Outcome Measures

Primary Outcomes (4)

• Mineral Content Assessment (ΔF / Depth of lesion)

  The buccal surfaces of the teeth were examined and evaluated by light induced fluorescence intraoral camera QLF-D Biluminator,™ (Inspektor-Pro, Amsterdam, Holland) for capturing fluorescent photographs in accordance with the manufacturer's instructions.

  The patients were evaluated at baseline (T0) and every 30 days intervals for 3 months.

• Mineral Content Assessment (LA / Lesion area)

  The buccal surfaces of the teeth were examined and evaluated by light induced fluorescence intraoral camera QLF-D Biluminator,™ (Inspektor-Pro, Amsterdam, Holland) for capturing fluorescent photographs in accordance with the manufacturer's instructions.

  The patients were evaluated at baseline (T0) and every 30 days intervals for 3 months.

• Mineral Content Assessment (∆Q / Lesion volume)

  The buccal surfaces of the teeth were examined and evaluated by light induced fluorescence intraoral camera QLF-D Biluminator,™ (Inspektor-Pro, Amsterdam, Holland) for capturing fluorescent photographs in accordance with the manufacturer's instructions.

  The patients were evaluated at baseline (T0) and every 30 days intervals for 3 months.

• Mineral Content Assessment (∆Fmax / Maximum fluorescence loss)

  The buccal surfaces of the teeth were examined and evaluated by light induced fluorescence intraoral camera QLF-D Biluminator,™ (Inspektor-Pro, Amsterdam, Holland) for capturing fluorescent photographs in accordance with the manufacturer's instructions.

  The patients were evaluated at baseline (T0) and every 30 days intervals for 3 months.

Secondary Outcomes (1)

• Visual Caries Regression Assessment

  The patients were evaluated at baseline (T0) and every 30 days intervals for 3 months.

Study Arms (3)

MI Paste Plus

EXPERIMENTAL

Patients were instructed to use MI Paste Plus (GC Europe, Leuven, Belgium) according to manufacturers instructions.

Combination Product: MI Paste Plus

Remin Pro

EXPERIMENTAL

Patients were instructed to use (Remin Pro, VOCO GmbH, Cuxhaven, Germany) a pea-sized amount of the cream.

Combination Product: Remin Pro

Control

ACTIVE COMPARATOR

Patients used a 1450 ppm fluoridated tooth paste (Colgate Sensitive Pro-Relief, Colgate-Palmolive, Swidnica, Poland) for conventional tooth brushing.

Combination Product: Control

Interventions

MI Paste Plus COMBINATION_PRODUCT

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.

MI Paste Plus

Remin Pro COMBINATION_PRODUCT

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.

Remin Pro

Control COMBINATION_PRODUCT

Patients instructed to follow a routine home care.

Control

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 25 years of age,
• at least 12 months of orthodontic treatment with braces,
• at least one upper anterior tooth with WSL.

You may not qualify if:

• smoking,
• enamel hypoplasia or fluorosis,
• active periodontal disease,
• dentin caries,
• allergy to casein,
• previous bleaching.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Sevgi Göl Peynirci

Konak, İzmir, 35220, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding was not feasible during the intervention, but the data evaluation and outcome assessment were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Thirty-nine patients were randomized in a 1:1:1 ratio to either MI Paste Plus or Remin Pro or control group.

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: December 20, 2023
• Study Start: February 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: May 25, 2022
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

TU (1)