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

NCT ID: NCT05631197

Last Updated: 2023-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-02

Study Completion Date

2023-09-30

Brief Summary

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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 Protection Plus + 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).

Detailed Description

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Conditions

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Dental Caries Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Trial group

Group Type EXPERIMENTAL

Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment

Intervention Type OTHER

Domiciliary use twice a day

Control group

Group Type ACTIVE_COMPARATOR

Sensodyne Repair & Protect

Intervention Type OTHER

Domiciliary use twice a day

Interventions

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Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment

Domiciliary use twice a day

Intervention Type OTHER

Sensodyne Repair & Protect

Domiciliary use twice a day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* pediatric patients aged between 6-14 years
* diagnosis of allergic rhinitis and asthma
* therapy with salmeterol/fluticasone propionate
* diffused enamel demineralizations of deciduous and permanent teeth

Exclusion Criteria

* low cooperation according to grades 3 and 4 of Frankl behavioral scale
* nonadherence to the study protocol checked by parents
* other systemic diseases.
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, DDS, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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

Pavia, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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2022-PEDOBIOREPAIR

Identifier Type: -

Identifier Source: org_study_id

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