Domiciliary Management of Dental Erosion in Patients With GERD With Biomimetic Hydroxyapatite

Primary outcomes

1. 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.

2. 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;

   • 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.

3. 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

4. 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

   • isolated visible spots
   • blood forms a confluent red line on the mucosal margin
   • profuse and copious bleeding

5. 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.

6. 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.