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

Study Overview
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Brief Summary
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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
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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

Official Title
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Management of Dental Erosion in Patients With Gastroesophageal Reflux Disease With Biomimetic Hydroxyapatite Toothpaste

Conditions
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Gastro Esophageal Reflux, Dental Erosion

Intervention / Treatment
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* Other: Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment
* Other: Biorepair Total Protection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial Group<br>Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment application | Other: Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment<br>* Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.<br>|
| Active Comparator: Control group<br>Domiciliary use of Biorepair Total Protection | Other: Biorepair Total Protection<br>* Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Study begin, 1, 3 and 6 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. | Study begin, 1, 3 and 6 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 | Study begin, 1, 3 and 6 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 | Study begin, 1, 3 and 6 months after the baseline | 
| 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. | Study begin, 1, 3 and 6 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. | Study begin, 1, 3 and 6 months after the baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomimetic hydroxyapatite, remineralization