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Completed

NCT Number: NCT05631197

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

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).

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Key information

Conditions

Dental Caries Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment

Other

Domiciliary use twice a day

Sensodyne Repair & Protect

Other

Domiciliary use twice a day

Primary outcomes

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

    Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)

    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

  2. Change in Shiff Air Index - Dental sensitivity test

    Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)

    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.

  3. Change in BoP - Bleeding on Probing

    Time frame: 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.

  4. Change in PI - Plaque Index (Silness and Löe, 1964)

    Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)

    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.

  5. Change in salivary pH

    Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)

    Use of Just Fitter strips to assess salivary pH.

  6. Change in SI - Susceptibility Index

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2022
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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