Dental Caries, Periodontal Diseases
Conditions
Keywords
Dental hygiene
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).
Interventions
OTHERBiorepair Total Protection Plus + desensitizing enamel-repair shock treatment
Domiciliary use twice a day
Domiciliary use twice a day
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Shiff Air Index - Dental sensitivity test | Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) | Scoring criteria: 0 = the subject did not respond to air blasting; 1. = the subject responded to air blasting; 2. = the subject responded to air blasting and requested discontinuation; 3. = the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful. |
| Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al.2008) | Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) | 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. The BEWE will be assessed with Intact Tooth application |
| Change in BoP - Bleeding on Probing | Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) | Scoring criteria: Percentage of bleeding sites (mesial, distal, vestibular, lingual) of each teeth on the total available sites. |
| Change in PI - Plaque Index (Silness and Löe, 1964) | Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) | Scoring criteria: 0 = no plaque; 1. = thin plaque layer at the gingival margin, only detectable by scraping with a probe; 2. = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye; 3. = abundant plaque along the gingival margin; interdental spaces filled with plaque. |
| Change in salivary pH | Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) | Use of Just Fitter strips to assess salivary pH. |
| Change in SI - Susceptibility Index | Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) | 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 |
Countries
Italy
Outcome results
None listed