Clinical Efficacy of Biomimetic Hydroxyapatite in the Treatment of Molar Incisor Hypomineralization.

March 22, 2022 updated by: Andrea Scribante, University of Pavia

Effects of Biomimetic Hydroxyapatite in the Treatment of Molar Incisor Hypomineralization: a Randomized Clinical Trial.

The aim of the following study is to evaluate che clinical efficacy of a toothpaste with biomimetic hydroxyapatite for the management of Molar-Incisor Hypomineralization. Patients who agree to participate to the study will use Biorepair toothpaste for the first 7 days of the month for 3, 6 and 9 months. The following indices will be measured: BEWE, Bleeding Index, Gingival index, Plaque index and the dental sensitivity test. The contralateral tooth will be used as control if not affected by MIH; otherwise, adjacent teeth will be considered.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Informed consent will be signed by the parents of the patients underage; patients will be asked the approval for the attendance of the study.

Adult patients will sign the informed consent for the treatment and for processing personal data for research purpose, with their approval for the attendance of the study.

Patients will be given for free a toothpaste with biomimetic hydroxyapatite (Biorepair Enamel-Repair Shock Treatment) and the Investigator will explain the correct procedures for home oral care. The toothpaste will be applied the first 7 days of the month for 9 months with a specific tray.

Teeth will be randomly assigned to:

  • Trial group: 1 tooth with MIH from 1 quadrant will be treated with the biomimetic hydroxyapatite toothpaste. The applications will be performed for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes).
  • Control group: 1 contralateral tooth with MIH will not be treated with the biomimetic hydroxyapatite toothpaste Patients will be visited after 1, 2, 3, 6 and 9 months from the baseline. For each visit, BEWE index, Bleeding Index, Gingival index, Plaque index and Dental sensitivity test. Tooth with MIH will be assessed, together with its contralaterals as control. If the contralateral tooth should suffer from MIH too, measurements will be carried out on the adjacent tooth.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of at least 2 enamel demineralizations of permanent molars and incisors (Molar-Incisor Hypomineralization - MIH) in contralateral quadrants
  • good general health (absence of systemic diseases)

Exclusion Criteria:

  • patients undergoing orthodontic therapy
  • patients taking drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trial Group
Teeth from this group suffer from MIH. They will be evaluated after home oral care with BioRepair toothpaste containing microRepair®.
Other: Biorepair Shock Treatment
Teeth from this group will undergo the application of Biorepair Toothpaste for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes).
Active Comparator: Control Group
Teeth from this group suffer from MIH. They are in the contralateral quadrants in respect to teeth from trial group. They will not be treated with the hydroxyapatite toothpaste.
Other: No treatment
Teeth from this group will not be treated with the experimental toothpaste.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of BI - Bleeding Index
Time Frame: Study begin, 1,2,3, 6 and 9 months

Scoring criteria:

  • 0: absence of bleeding after 30 seconds
  • 1: bleeding observed after 30 seconds
  • 2: immediate bleeding
Study begin, 1,2,3, 6 and 9 months
Change of GI - Gingival Index (Loe and Silness, 1963)
Time Frame: Study begin, 1,2,3, 6 and 9 months

Scoring criteria:

  • 0 = normal gingiva.
  • 1 = mild inflammation, edema and swelling; no bleeding.
  • 2 = moderate inflammation with edema, swelling and bleeding on probing.
  • 3 = severe inflammation with marked edema, redness tissues, ulceration and spontaneous bleeding.
Study begin, 1,2,3, 6 and 9 months
Change of PCR - Plaque Control Record (O'Leary, 1972)
Time Frame: Study begin, 1,2,3, 6 and 9 months

4 surfaces scored (mesial, distal, vestibular, labial/palatal) per tooth by means of plaque relevator.

The Index is calculated multiplying the total number of surfaces with plaque per 100.
Study begin, 1,2,3, 6 and 9 months
Change in Schiff Air Index - Dental sensitivity test
Time Frame: Study begin, 1,2,3, 6 and 9 months

Scoring criteria:

0. the subject did not respond to air blasting;

  1. the subject responded to air blasting;
  2. the subject responded to air blasting and requested discontinuation;
  3. the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.
Study begin, 1,2,3, 6 and 9 months
Change of BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)
Time Frame: Study begin, 1,2,3, 6 and 9 months

Scoring criteria:

  • 0: no erosive tooth wear;
  • 1: initial loss of surface texture;
  • 2: distinct defect, hard tissue loss < 50% of the surface area;
  • 3: hard tissue loss ≥ 50% of the surface area.

Additionally, risk level for clinical management will be assessed.
Study begin, 1,2,3, 6 and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2021

Primary Completion (Actual)

January 30, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-MIH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon motivated request to Principal Investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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