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

NCT04808180 | Completed

• 1 other identifier: 2021-MIH
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Molar Incisor Hypomineralization

Keywords

biomimetic hydroxyapatite; enamel remineralization

Outcome Measures

Primary Outcomes (5)

• Change of BI - Bleeding Index

  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)

  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)

  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

  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)

  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

Study Arms (2)

Trial Group

EXPERIMENTAL

Teeth from this group suffer from MIH. They will be evaluated after home oral care with BioRepair toothpaste containing microRepair®.

Other: Biorepair Shock Treatment

Control Group

ACTIVE COMPARATOR

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

Interventions

Biorepair Shock Treatment OTHER

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).

Trial Group

No treatment OTHER

Teeth from this group will not be treated with the experimental toothpaste.

Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• patients undergoing orthodontic therapy
• patients taking drugs

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andrea Scribante, DDS, PhD.

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Resident, Principal Investigator

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 22, 2021
• Study Start: March 25, 2021
• Primary Completion: January 30, 2022
• Study Completion: February 1, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)