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

Molar Incisor Hypomineralization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04808180
• Other study ID #: 2021-MIH
• Status: Completed
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2022
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 1, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

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).
• No treatment
Teeth from this group will not be treated with the experimental toothpaste.

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change in Schiff Air Index - Dental sensitivity test	Scoring criteria: 0. the subject did not respond to air blasting; the subject responded to air blasting; the subject responded to air blasting and requested discontinuation; the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.	Study begin, 1,2,3, 6 and 9 months
Primary	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