NCT04382287

Brief Summary

The present study aimed to compare the remineralisation capacity of white spot enamel lesions between two commercially available tooth pastes (Remin Pro and MI PASTE PLUS), applied at home twice a day on the anterior upper primary teeth by the patient and parents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

May 5, 2020

Last Update Submit

May 7, 2020

Conditions

White Spot Lesion

Keywords

Primary teethEnamelRemineralisation

Outcome Measures

Primary Outcomes (2)

  • Enamel remineralisation degree

    The remineralisation degree was quantified by the change in UF from the baseline (0 day) up to day 10 of twice-daily applications, by evaluation on the 10th day.

    10 days

  • Enamel remineralisation degree

    The remineralisation degree was quantified by the change in UF from the 10th day up to the 21st day, after twice-daily applications

    21 days

Study Arms (3)

REMIN paste

EXPERIMENTAL

The child's parents or caregivers were provided with printed instructions for applying the paste at home. The indicated procedure was as follows: application of the remineralisation agent was limited to the tooth's vestibular surface twice a day, after conventional toothbrushing (both in the morning and at night). The maximal amount of paste to be applied was equal to a pea-sized portion (one finger) per surface. The paste was applied using the parent or caregiver's finger across the WSL surface. After the application of the paste, patients were asked to avoid eating or drinking anything for the next hour.

Procedure: Remin Pro® and MI Paste Plus®

MI PASTE PLUS

EXPERIMENTAL

The child's parents or caregivers were provided with printed instructions for applying the paste at home. The indicated procedure was as follows: application of the remineralisation agent was limited to the tooth's vestibular surface twice a day, after conventional toothbrushing (both in the morning and at night). The maximal amount of paste to be applied was equal to a pea-sized portion (one finger) per surface. The paste was applied using the parent or caregiver's finger across the WSL surface. After the application of the paste, patients were asked to avoid eating or drinking anything for the next hour.

Procedure: Remin Pro® and MI Paste Plus®

COLGATE Total

ACTIVE COMPARATOR

The child's parents or caregivers were provided with printed instructions for applying the paste at home. The indicated procedure was as follows: application of the remineralisation agent was limited to the tooth's vestibular surface twice a day, after conventional toothbrushing (both in the morning and at night). The maximal amount of paste to be applied was equal to a pea-sized portion (one finger) per surface. The paste was applied using the parent or caregiver's finger across the WSL surface. After the application of the paste, patients were asked to avoid eating or drinking anything for the next hour.

Procedure: Remin Pro® and MI Paste Plus®

Interventions

Remin Pro® and MI Paste Plus®PROCEDURE

Te toothastes were applied at home twice a day over the six anterior upper primary teeth

COLGATE TotalMI PASTE PLUSREMIN paste

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Young paediatric patients with at least one upper anterior primary tooth exhibiting one or several WSL on the smooth enamel surface.
  • Attending the Paediatric Dentistry Postgraduate Program's Clinic
  • Enamel lesions with units of fluorescence (UF) ranging from 11-20 as determined by DIAGNOdent
  • Signed Informed Consent

You may not qualify if:

  • History of hypersensitivity to any of the compounds of the pastes
  • Enamel hypoplasia
  • Compromising systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Universidad Autónoma de san Luis Potosi

San Luis Potosí City, 78990, Mexico

Location

Study Officials

  • Amaury Pozos-Guillén, PhD

    San Luis Potosi University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
The three provided pastes had a similar physical appearance
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomised double-blind clinical trial, with three parallel study groups (two experimental and one control), whose participants were randomly assigned to one of te three groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 11, 2020

Study Start

April 1, 2019

Primary Completion

September 9, 2019

Study Completion

November 20, 2019

Last Updated

May 11, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)