The Effect of Oral Sprays on Salivary pH

Oral Health Clinical Trial

Official title:

The Effect of Oral Sprays on Salivary pH Changes After Coca-cola Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06148662
• Other study ID #: 18081215
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2023
• Est. completion date: January 25, 2024

Study information

• Verified date: November 2023
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to assess the effect of oral foams on salivary pH changes after Coca-cola consumption in young adults.

Description:

This will be a cross-over clinical trial assessing the effect of oral foams containing zink hydroxiapatite and probiotics (Lactobacillus, Bifidobacterium), Olaflur (amino fluoride), and oral spray with alkaline thermal water. The study will be conducted in six visits over a period of 1.5 months. After enrolment, dental examination will be performed using the following indices: DMFT, OHI-S index, Bleeding index. Saliva buffer capacity, salivary flow rate, and baseline salivary pH will be measured. Salivary pH changes will be registered after consumption of Coca-cola alone or followed by each of the tested products application.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Females and males
• Aged between 18-44 years
• Willingness to comply with all study procedures and availability for the duration of the study.
• Subjects who signed informed consent

Exclusion Criteria:

• History of chemotherapy or radiotherapy;
• An oral mucosa pathology;
• Orthodontic treatment within the previous 3 months;
• Dental bleaching within the previous 3 months;
• Withdrawal of consent;
• Patient refusal to continue participation in the study;
• Detection of an allergic reaction to any components of the dental foams or carbonated drinks used in the study.

Related Conditions & MeSH terms

• Oral Health

Intervention

Other:
• No intervention (negative control)
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds.
• Water (positive control)
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will to rinse their mouth with tap water 60 seconds.

Drug:
• Dental foam "Biorepair PERIBIOMA"
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will use a dental foam "Biorepair PERIBIOMA" to rinse their mouth. They should rinse their mouth for 60 seconds and then spit out the foam.
• Dental foam "WATER:DENT"
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will use a dental foam "WATER:DENT" to rinse their mouth. They should rinse their mouth for 60 seconds and then spit out the foam.
• Dental spray "BUCCOTHERM"
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will use a dental spray "BUCCOTHERM" to rinse their mouth. They should rinse their mouth for 60 seconds and then spit out the foam.

Locations

Country	Name	City	State
Russian Federation	Institute of Dentistry of Sechenov University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time required for salivary pH recovery after Coca-Cola consumption	The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption and further every 5 minutes until the pH reaches baseline levels. Salivary pH levels will be measured with a digital pH meter. The time required for pH recovery will be registered.	1 hour
Primary	The time required for salivary pH recovery after Coca-Cola consumption followed by oral sprays application	The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will be asked to rinse their mouths with tap water (control) or each of the tested oral foams according to the manufacturer's recommendations. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption, immediately after oral foams/tap water rinse and further every 5 minutes until the pH reaches baseline levels. The pH levels will be measured with a digital pH meter. The time required for pH recovery will be registered.	1 hour
Primary	Minimal value of salivary pH after Coca-Cola consumption	The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption and further every 5 minutes until the pH reaches baseline levels. Salivary pH levels will be measured with a digital pH meter. The minimal pH value will be registered.	1 hour
Primary	minimal value of salivary pH recovery after Coca-Cola consumption followed by oral sprays application	The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will be asked to rinse their mouths with tap water (control) or each of the tested oral foams according to the manufacturer's recommendations. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption, immediately after oral foams/tap water rinse and further every 5 minutes until the pH reaches baseline levels. The pH levels will be measured with a digital pH meter. The minimal pH value will be registered.	1 hour