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

NCT05371717 | Completed

• 1 other identifier: 2022-GASTRO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro Esophageal Reflux; Dental Erosion

Keywords

biomimetic hydroxyapatite; remineralization

Outcome Measures

Primary Outcomes (6)

• 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, 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.

  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

  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

  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.

  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.

  Study begin, 1, 3, 6, 9 and 12 months after the baseline

Study Arms (2)

Trial Group

EXPERIMENTAL

Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment application

Other: Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment

Control group

ACTIVE COMPARATOR

Domiciliary use of Biorepair Total Protection

Other: Biorepair Total Protection

Interventions

Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment OTHER

Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.

Trial Group

Biorepair Total Protection OTHER

Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with dental erosion
• no proton pumps before pH examination

You may not qualify if:

• no dental erosion
• neurological and psychiatric diseases;
• pregnant and/or breastfeeding women;
• patients with poor compliance.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Tooth Erosion

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Study Officials

• Andrea Scribante, DDS, PhD, MS

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 12, 2022
• Study Start: May 1, 2022
• Primary Completion: September 17, 2024
• Study Completion: September 20, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)