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

Not Applicable

Completed

• Conditions: Gastro Esophageal Reflux; Dental Erosion
• Interventions: Other: Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment; Other: Biorepair Total Protection

• Registration Number: NCT05371717
• Lead Sponsor: University of Pavia

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.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-07
• Study First Posted: 2022-05-12
• Primary Completion: 2024-09-17
• Study Completion: 2024-09-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-20
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trial Group	Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment	Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment application
Control group	Biorepair Total Protection	Domiciliary use of Biorepair Total Protection

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy