Dental CariesNCT05631197
Biomimetic Hydroxyapatite in Pediatric Patients With Asthma and/or Allergic Rhinitis
A study testing Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment and Sensodyne Repair & Protect in people with Dental Caries and Periodontal Diseases, run by University of Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Dental Caries, Periodontal Diseases
- What is being tested?
- Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment and Sensodyne Repair & Protect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 2 Mar 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- low cooperation according to grades 3 and 4 of Frankl behavioral scale
- nonadherence to the study protocol checked by parents
- other systemic diseases.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: 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).
- Conditions
- Dental Caries, Periodontal Diseases
- Being tested
- Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment, Sensodyne Repair & Protect
- Keywords
- Dental hygiene
- Medical subject headings
- Dental Caries, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biorepair Total Protection Plus + desensitizing enamel-repair shock treatmentOther
Domiciliary use twice a day
Sensodyne Repair & ProtectOther
Domiciliary use twice a day
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | Not described Receives: Other: Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment |
| Control group | Active comparator | Not described Receives: Other: Sensodyne Repair & Protect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
Change in salivary pH
Use of Just Fitter strips to assess salivary pH.
Measured: 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
Measured: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start2 Mar 2022
- Primary completion27 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, MS, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631197
- Sponsor's protocol ID
- 2022-PEDOBIOREPAIR
- Status last verified
- Nov 2023
- First submitted
- 18 Nov 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomimetic Hydroxyapatite vs Fluoride for the Domiciliary Oral Hygiene of Pediatric Patients With Asthma and/or Allergic Rhinitis: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05631197
- Acronym / sponsor ID
- 2022-PEDOBIOREPAIR
- Conditions
- Dental Caries, Periodontal Diseases
- Keywords
- Dental hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial group | Experimental | Other: Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment |
| Control group | Active comparator | Other: Sensodyne Repair & Protect |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- low cooperation according to grades 3 and 4 of Frankl behavioral scale
- nonadherence to the study protocol checked by parents
- other systemic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biorepair Total Protection Plus + desensitizing enamel-repair shock treatmentDomiciliary use twice a day | Other | Trial group |
| Sensodyne Repair & ProtectDomiciliary use twice a day | Other | Control group |
Primary outcome
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; 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
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; 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.
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.
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; 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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD, MS principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment and Sensodyne Repair & Protect in people with Dental Caries and Periodontal Diseases, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.