Gastro Esophageal RefluxNCT05371717
Domiciliary Management of Dental Erosion in Patients With GERD With Biomimetic Hydroxyapatite
A study testing Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment and Biorepair Total Protection in people with Gastro Esophageal Reflux and Dental Erosion, run by University of Pavia at 1 site in Italy.
Trial summary
The aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (GERD). Patients consenting to participate to the study will undergo periodontal evaluation at the baseline. Then, professional dental hygiene will be performed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastro Esophageal Reflux, Dental Erosion
- What is being tested?
- Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment and Biorepair Total Protection
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2022to 20 Sep 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with dental erosion
- no proton pumps before pH examination
Who cannot join
- no dental erosion
- neurological and psychiatric diseases;
- pregnant and/or breastfeeding women;
- patients with poor compliance.
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: Management of Dental Erosion in Patients With Gastroesophageal Reflux Disease With Biomimetic Hydroxyapatite Toothpaste
The aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (GERD).
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline. Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
- Trial group: home oral hygiene with Biorepair Total Protection + Biorepair Shock Treatment twice a day
- Control group: home oral hygiene with Biorepair Total Protection Patients will be evaluated after 1, 3, 6, 9 and 12 months from baseline.
Read the detailed description
The aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (GERD).
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline. Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
- Trial group: home oral hygiene with Biorepair Total Protection + Biorepair Shock Treatment twice a day
- Control group: home oral hygiene with Biorepair Total Protection Patients will be evaluated after 1, 3, 6, 9 and 12 months from baseline.
- Conditions
- Gastro Esophageal Reflux, Dental Erosion
- Being tested
- Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment, Biorepair Total Protection
- Keywords
- biomimetic hydroxyapatite, remineralization
- Medical subject headings
- Gastroesophageal Reflux, Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Domiciliary use of Biorepair Total Protection + Biorepair Shock TreatmentOther
Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.
Biorepair Total ProtectionOther
Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.
| Study group | Role | What they receive |
|---|---|---|
| Trial Group | Experimental | Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment application Receives: Other: Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment |
| Control group | Active comparator | Domiciliary use of Biorepair Total Protection Receives: Other: Biorepair Total Protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of BEWE (Basic Erosive Wear Examination)
Scoring criteria (Barlet et al., 2008):
- 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.
IntactTooth smartphone application will be used to calculate this index.
Measured: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Change in Schiff 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: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Change in Plaque Index (PI% - O' Leary Index)
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.
Formula = n ° sites with plaque / total n ° of dental surfaces x100
Measured: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Change in Bleeding Score (BS - Mombelli et al.)
Scoring criteria:
0: no bleeding
- isolated visible spots
- blood forms a confluent red line on the mucosal margin
- profuse and copious bleeding
Measured: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Laryngopharyngeal pH monitoring
Data was collected wirelessly for 24 hours and then analysed. Length, severity and number of reflux episodes were calculated. The RYAN score was used to evaluate for laryngopharyngeal acid reflux and was calculated for both the upright and supine positions. A RYAN score >9.4 in the upright position or >6.8 in the supine position was considered positive. Patients with a positive RYAN score in either the upright or supine positions were considered positive for laryngopharyngeal acid reflux.
Measured: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Erosion risk level
For each sextant, the highest BEWE value will be chosen. A mean of all the sextant values will be performed to calculate erosion risk level.
IntactTooth smartphone application will be used to calculate this index.
Measured: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 May 2022
- Primary completion17 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT05371717
- Sponsor's protocol ID
- 2022-GASTRO
- Status last verified
- Oct 2024
- First submitted
- 3 May 2022
- Last updated
- 23 Oct 2024
- 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Dental Erosion in Patients With Gastroesophageal Reflux Disease With Biomimetic Hydroxyapatite Toothpaste
- ClinicalTrials.gov ID
- NCT05371717
- Acronym / sponsor ID
- 2022-GASTRO
- Conditions
- Gastro Esophageal Reflux, Dental Erosion
- Keywords
- biomimetic hydroxyapatite, remineralization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 12 May 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 present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (GERD).
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline. Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
- Trial group: home oral hygiene with Biorepair Total Protection + Biorepair Shock Treatment twice a day
- Control group: home oral hygiene with Biorepair Total Protection Patients will be evaluated after 1, 3, 6, 9 and 12 months from baseline.
Detailed description
The aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (GERD).
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline. Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
- Trial group: home oral hygiene with Biorepair Total Protection + Biorepair Shock Treatment twice a day
- Control group: home oral hygiene with Biorepair Total Protection Patients will be evaluated after 1, 3, 6, 9 and 12 months from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Group | Experimental | Other: Domiciliary use of Biorepair Total Protection + Biorepair Shock TreatmentDomiciliary use of Biorepair Total Protection + Biorepair Shock Treatment application |
| Control group | Active comparator | Other: Biorepair Total ProtectionDomiciliary use of Biorepair Total Protection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with dental erosion
- no proton pumps before pH examination
Key exclusion criteria (4 listed)
- no dental erosion
- neurological and psychiatric diseases;
- pregnant and/or breastfeeding women;
- patients with poor compliance.
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 |
|---|---|---|
| Domiciliary use of Biorepair Total Protection + Biorepair Shock TreatmentDomiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day. | Other | Trial Group |
| Biorepair Total ProtectionDomiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day. | Other | Control group |
Primary outcome
Change of BEWE (Basic Erosive Wear Examination)
Time frame: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Scoring criteria (Barlet et al., 2008): * 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. IntactTooth smartphone application will be used to calculate this index.
Change in Schiff Air Index - Dental sensitivity test
Time frame: Study begin, 1, 3, 6, 9 and 12 months after the baseline
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 Plaque Index (PI% - O' Leary Index)
Time frame: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100
Change in Bleeding Score (BS - Mombelli et al.)
Time frame: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Scoring criteria: 0: no bleeding 1. isolated visible spots 2. blood forms a confluent red line on the mucosal margin 3. profuse and copious bleeding
Laryngopharyngeal pH monitoring
Time frame: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Data was collected wirelessly for 24 hours and then analysed. Length, severity and number of reflux episodes were calculated. The RYAN score was used to evaluate for laryngopharyngeal acid reflux and was calculated for both the upright and supine positions. A RYAN score >9.4 in the upright position or >6.8 in the supine position was considered positive. Patients with a positive RYAN score in either the upright or supine positions were considered positive for laryngopharyngeal acid reflux.
Erosion risk level
Time frame: Study begin, 1, 3, 6, 9 and 12 months after the baseline
For each sextant, the highest BEWE value will be chosen. A mean of all the sextant values will be performed to calculate erosion risk level. IntactTooth smartphone application will be used to calculate this index.
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 23 Oct 2024.
- 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 Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment and Biorepair Total Protection in people with Gastro Esophageal Reflux and Dental Erosion, 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 2 inclusion and 4 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 23 Oct 2024. 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 BEWE (Basic Erosive Wear Examination) (time frame: Study begin, 1, 3, 6, 9 and 12 months after the baseline). 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 23 Oct 2024.