Biomimetic Hydroxyapatite in Pediatric Patients With Asthma and/or Allergic Rhinitis

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Biorepair Total Protective + desensitizing enamel-repair shock treatment

Sensodyne Repair & Protect

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Dental hygiene

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed with asthma and/or allergic rhinitis Patients with enamel demineralizations Exclusion Criteria: Healthy subjects Low compliance and motivation

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trial group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al.2008)

Scoring criteria: 0 = no erosive tooth wear; = initial loss of surface texture; = distinct defect, hard tissue loss < 50% of the surface area; = hard tissue loss ≥ 50% of the surface area. The BEWE will be assessed with Intact Tooth application

Change in Shiff 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.

Change in BS - Bleeding Score

Scoring criteria: 0 = no bleeding; = punctiform bleeding in the site of probing; = slightly extended bleeding in the site of probing; = bleeding in more than a half of gingival margin; = gingival border fully covered by blood.

Change in PI - Plaque Index (Silness and Löe, 1964)

Scoring criteria: 0 = no plaque; = thin plaque layer at the gingival margin, only detectable by scraping with a probe; = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye; = abundant plaque along the gingival margin; interdental spaces filled with plaque.

Change in salivary pH

Use of Just Fitter strips to assess salivary pH.

Secondary Outcome Measures

Full Information

NCT ID

NCT05631197

First Posted

November 18, 2022

Last Updated

October 22, 2023

Sponsor

University of Pavia

1. Study Identification

Unique Protocol Identification Number

NCT05631197

Brief Title

Biomimetic Hydroxyapatite in Pediatric Patients With Asthma and/or Allergic Rhinitis

Official Title

Biomimetic Hydroxyapatite vs Fluoride for the Domiciliary Oral Hygiene of Pediatric Patients With Asthma and/or Allergic Rhinitis: Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

March 2, 2022 (Actual)

Primary Completion Date

September 27, 2023 (Actual)

Study Completion Date

September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

The aim of the study is to compare the incidence of dental caries and the level of demineralization in pediatric patients with asthma and/or allergic rhinitis. Patients will conduct professional oral hygiene at the baseline. The following clinical indexes will be assessed: BEWE Index, Plaque Index, Bleeding Score, Schiff Air Index. Then, patients will be randomly divided into two groups: Trial group: domiciliary use of Biorepair Total Protective + desensitizing enamel-repair shock treatment twice a day Control group: domiciliary use of Elmex Caries Protection twice a day The clinical indexes will be assessed again after 1 month (T1), after 3 (T2) and 6 months (T3).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries, Periodontal Diseases

Keywords

Dental hygiene

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Trial group

Arm Type

Experimental

Arm Title

Control group

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Biorepair Total Protective + desensitizing enamel-repair shock treatment

Intervention Description

Domiciliary use twice a day

Intervention Type

Other

Intervention Name(s)

Sensodyne Repair & Protect

Intervention Description

Domiciliary use twice a day

Primary Outcome Measure Information:

Title

Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al.2008)

Description

Scoring criteria: 0 = no erosive tooth wear; = initial loss of surface texture; = distinct defect, hard tissue loss < 50% of the surface area; = hard tissue loss ≥ 50% of the surface area. The BEWE will be assessed with Intact Tooth application

Time Frame