An interventional study of Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment and Biorepair Total Protection in Gastro Esophageal Reflux and Dental Erosion, sponsored by University of Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by University of Pavia · Not applicable, Interventional, and Treatment
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:
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:
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's enrollment of 30 is below the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →University of Pavia is the lead sponsor of 144 studies on the registry; 39 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment application
Other: Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment
Domiciliary use of Biorepair Total Protection
Other: Biorepair Total Protection
Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.
Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.
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.
Time frame: 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; 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.
Time frame: 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
Time frame: 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 1. isolated visible spots 2. blood forms a confluent red line on the mucosal margin 3. profuse and copious bleeding
Time frame: 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.
Time frame: 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.
Time frame: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Plan to share: No — Data will be available upon motivated request to the Principal Investigator.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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