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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05631197
• Other study ID #: 2022-PEDOBIOREPAIR
• Status: Completed
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2023
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Periodontal Diseases
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment
Domiciliary use twice a day
• Sensodyne Repair & Protect
Domiciliary use twice a day

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Change in salivary pH	Use of Just Fitter strips to assess salivary pH.	Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
Primary	Change in SI - Susceptibility Index	Scoring criteria: mild: 6.7< pH <7.8, BEWE 0-1, SAI 0-1; moderate: 6.0 severe: pH <6.6, BEWE 2-3, SAI 2-3	Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)