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

Sponsor

University of Pavia (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05631197

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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 Protective + desensitizing enamel-repair shock treatment twice a day
Control group: domiciliary use of Elmex Caries Protection + topical application of fluoridated gel twice a day

The clinical indexes will be assessed again after 1 month (T1), after 3 (T2) and 6 months (T3).

Condition or Disease	Intervention/Treatment	Phase
Dental Caries Periodontal Diseases	Other: Biorepair Total Protective + desensitizing enamel-repair shock treatment Other: Elmex Caries Protection + topical application of fluoridated gel	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 2, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trial group	Other: Biorepair Total Protective + desensitizing enamel-repair shock treatment Domiciliary use twice a day
Active Comparator: Control group	Other: Elmex Caries Protection + topical application of fluoridated gel Domiciliart use twice a day

Arm

Intervention/Treatment

Experimental: Trial group

Other: Biorepair Total Protective + desensitizing enamel-repair shock treatment

Domiciliary use twice a day

Active Comparator: Control group

Other: Elmex Caries Protection + topical application of fluoridated gel

Domiciliart use twice a day

Outcome Measures

Primary Outcome Measures

Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al.2008) 2008) [Baseline (T0), after 1 month (T1), after 3 months (T2), after 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
Change in Schiff Air Index - Dental sensitivity test [Baseline (T0), after 1 month (T1), after 3 months (T2), after 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.
Change in BS - Bleeding Score [Baseline (T0), after 1 month (T1), after 3 months (T2), after 6 months (T3)]
Scoring criteria: 0 = no bleeding; = punctiform bleeding in the site of probing; = slightly extended bleeding in the site of probing; = bleeding in more than a half of gingival margin; = gingival border fully covered by blood.
Change in PI - Plaque Index (Silness and Löe, 1964) [Baseline (T0), after 1 month (T1), after 3 months (T2), after 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with asthma and/or allergic rhinitis
Patients with enamel demineralizations

Exclusion Criteria:

Healthy subjects
Low compliance and motivation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy	Italy	27100

Sponsors and Collaborators

University of Pavia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrea Scribante, Associate Professor, Principal Investigator, University of Pavia

ClinicalTrials.gov Identifier:

NCT05631197

Other Study ID Numbers:

2022-PEDOBIOREPAIR

First Posted:

Nov 30, 2022

Last Update Posted:

Nov 30, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Andrea Scribante, Associate Professor, Principal Investigator, University of Pavia

Dental hygiene

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2022