Domiciliary Management of Dental Erosion in Patients With GERD With Biomimetic Hydroxyapatite
Primary Purpose
Gastro Esophageal Reflux, Dental Erosion
Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment
Biorepair Total Protection
Sponsored by
About this trial
This is an interventional treatment trial for Gastro Esophageal Reflux focused on measuring biomimetic hydroxyapatite, remineralization
Eligibility Criteria
Inclusion Criteria:
- patients with dental erosion
- no proton pumps before pH examination
Exclusion Criteria:
- no dental erosion
- neurological and psychiatric diseases;
- pregnant and/or breastfeeding women;
- patients with poor compliance.
Sites / Locations
- Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Trial Group
Control group
Arm Description
Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment application
Domiciliary use of Biorepair Total Protection
Outcomes
Primary Outcome Measures
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.
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.
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
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
Laryngopharyngeal pH monitoring 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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05371717
Brief Title
Domiciliary Management of Dental Erosion in Patients With GERD With Biomimetic Hydroxyapatite
Official Title
Management of Dental Erosion in Patients With Gastroesophageal Reflux Disease With Biomimetic Hydroxyapatite Toothpaste
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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 and 6 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 and 6 months from baselin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux, Dental Erosion
Keywords
biomimetic hydroxyapatite, remineralization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trial Group
Arm Type
Experimental
Arm Description
Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment application
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Domiciliary use of Biorepair Total Protection
Intervention Type
Other
Intervention Name(s)
Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment
Intervention Description
Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.
Intervention Type
Other
Intervention Name(s)
Biorepair Total Protection
Intervention Description
Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.
Primary Outcome Measure Information:
Title
Change of BEWE (Basic Erosive Wear Examination)
Description
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.
Time Frame
Study begin, 1, 3 and 6 months after the baseline
Title
Change in Schiff Air Index - Dental sensitivity test
Description
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.
Time Frame
Study begin, 1, 3 and 6 months after the baseline
Title
Change in Plaque Index (PI% - O' Leary Index)
Description
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
Time Frame
Study begin, 1, 3 and 6 months after the baseline
Title
Change in Bleeding Score (BS - Mombelli et al.)
Description
Scoring criteria:
0: no bleeding
isolated visible spots
blood forms a confluent red line on the mucosal margin
profuse and copious bleeding
Time Frame
Study begin, 1, 3 and 6 months after the baseline
Title
Laryngopharyngeal pH monitoring pH monitoring
Description
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.
Time Frame
Study begin, 1, 3 and 6 months after the baseline
Title
Erosion risk level
Description
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.
Time Frame
Study begin, 1, 3 and 6 months after the baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with dental erosion
no proton pumps before pH examination
Exclusion Criteria:
no dental erosion
neurological and psychiatric diseases;
pregnant and/or breastfeeding women;
patients with poor compliance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Scribante, DDS, PhD, MS
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
City
Pavia
State/Province
Lombardy
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon motivated request to the Principal Investigator.
Learn more about this trial
Domiciliary Management of Dental Erosion in Patients With GERD With Biomimetic Hydroxyapatite
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