Clinical trial NCT05371717: Domiciliary Management of Dental Erosion in Patients With GERD With Biomimetic Hydroxyapatite
Official title: Management of Dental Erosion in Patients With Gastroesophageal Reflux Disease With Biomimetic Hydroxyapatite Toothpaste
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro Esophageal Reflux
Dental Erosion
Keywords: biomimetic hydroxyapatite
remineralization
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of BEWE (Basic Erosive Wear Examination)
timeFrame: Study begin, 1, 3, 6, 9 and 12 months after the baseline
measure: Change in Schiff Air Index - Dental sensitivity test
timeFrame: Study begin, 1, 3, 6, 9 and 12 months after the baseline
measure: Change in Plaque Index (PI% - O' Leary Index)
timeFrame: Study begin, 1, 3, 6, 9 and 12 months after the baseline
measure: Change in Bleeding Score (BS - Mombelli et al.)
timeFrame: Study begin, 1, 3, 6, 9 and 12 months after the baseline
measure: Laryngopharyngeal pH monitoring
timeFrame: Study begin, 1, 3, 6, 9 and 12 months after the baseline
measure: Erosion risk level
timeFrame: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: