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

NCT05631197 | Completed

• 1 other identifier: 2022-PEDOBIOREPAIR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Caries; Periodontal Diseases

Keywords

Dental hygiene

Outcome Measures

Primary Outcomes (6)

• Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al.2008)

  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

  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; 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.

  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; 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.

  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)

Study Arms (2)

Trial group

EXPERIMENTAL

Other: Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment

Control group

ACTIVE COMPARATOR

Other: Sensodyne Repair & Protect

Interventions

Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment OTHER

Domiciliary use twice a day

Trial group

Sensodyne Repair & Protect OTHER

Domiciliary use twice a day

Control group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• low cooperation according to grades 3 and 4 of Frankl behavioral scale
• nonadherence to the study protocol checked by parents
• other systemic diseases.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Dental Caries; Periodontal Diseases

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Mouth Diseases

Study Officials

• Andrea Scribante, DDS, PhD, MS

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: November 30, 2022
• Study Start: March 2, 2022
• Primary Completion: September 27, 2023
• Study Completion: September 30, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)