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

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

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).

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Dental Caries
• Intervention / Treatment: Other: Sensodyne Repair & Protect; Other: Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

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 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 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 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)

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Andrea Scribante, DDS, PhD, MS, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Actual): September 27, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Dental hygiene
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Tooth Demineralization; Tooth Diseases; Rhinitis; Rhinitis, Allergic; Dental Caries; Periodontal Diseases
• Other Study ID Numbers: 2022-PEDOBIOREPAIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon motivated request to the Principal Investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No