Biomimetic Hydroxyapatite in Pediatric Patients With Asthma and/or Allergic Rhinitis
- Conditions
- Dental CariesPeriodontal Diseases
- Interventions
- Other: Biorepair Total Protection Plus + desensitizing enamel-repair shock treatmentOther: Sensodyne Repair & Protect
- Registration Number
- NCT05631197
- Lead Sponsor
- University of Pavia
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- low cooperation according to grades 3 and 4 of Frankl behavioral scale
- nonadherence to the study protocol checked by parents
- other systemic diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Trial group Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment - Control group Sensodyne Repair & Protect -
- Primary Outcome Measures
Name Time Method 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 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 salivary pH Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) Use of Just Fitter strips to assess salivary pH.
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 applicationChange 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
🇮🇹Pavia, Lombardy, Italy