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

University of Pavia

Status: Completed

Conditions: Dental Caries; Periodontal Diseases

Treatments: Other: Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment; Other: Sensodyne Repair & Protect

Study type: Interventional

Funder types: Other

Identifiers

NCT05631197

2022-PEDOBIOREPAIR

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Trial group

Experimental group

Treatment:

Other: Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment

Control group

Active Comparator group

Treatment:

Other: Sensodyne Repair & Protect