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

Gastro Esophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05371717
• Other study ID #: 2022-GASTRO
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 20, 2024

Study information

• Verified date: February 2024
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and 6 months from baseline.

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 and 6 months from baselin

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 20, 2024
• Est. primary completion date: May 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Erosion
• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• Tooth Erosion

Intervention

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

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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