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

Study Overview
=================
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 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).

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

Conditions
-----------------
Dental Caries, Periodontal Diseases

Intervention / Treatment
-----------------
* Other: Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment
* Other: Sensodyne Repair & Protect


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial group<br> | Other: Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment<br>* Domiciliary use twice a day<br>|
| Active Comparator: Control group<br> | Other: Sensodyne Repair & Protect<br>* Domiciliary use twice a day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) | 
| 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. | Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) | 
| Change in BoP - Bleeding on Probing | Scoring criteria: Percentage of bleeding sites (mesial, distal, vestibular, lingual) of each teeth on the total available sites. | Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) | 
| 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. | Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) | 
| Change in salivary pH | Use of Just Fitter strips to assess salivary pH. | Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) | 
| Change in SI - Susceptibility Index | Scoring criteria: mild: 6.7< pH <7.8, BEWE 0-1, SAI 0-1 moderate: 6.0 <pH <6.6, BEWE 1-2, SAI 1-2 severe: pH <6.6, BEWE 2-3, SAI 2-3 | Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental hygiene