Dental Erosion, Gastro Esophageal Reflux
Conditions
Keywords
biomimetic hydroxyapatite, remineralization
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, 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.
Interventions
OTHERDomiciliary use of Biorepair Total Protection + Biorepair Shock Treatment
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.
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of BEWE (Basic Erosive Wear Examination) | 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 | 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) | 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.) | 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 | 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 | 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. |
Countries
Italy
Outcome results
None listed