The Effect of Oral Sprays on Salivary pH

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

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

Study Overview

• Status: Completed
• Conditions: Oral Health
• Intervention / Treatment: Other: No intervention (negative control); Other: Water (positive control); Drug: Dental foam "Biorepair PERIBIOMA"; Drug: Dental foam "WATER:DENT"; Drug: Dental spray "BUCCOTHERM"

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 121059
    • Institute of Dentistry of Sechenov University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No intervention (negative control); Negative control	Other: No intervention (negative control); The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds.
Experimental: Water (positive control); Tap water	Other: 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.
Experimental: Dental foam "Biorepair PERIBIOMA"; Ingredients: Aqua, Sorbitol, Xylitol, Zinc Hydroxyapatite, Aroma, Pistacia Lentiscus (Mastic) Gum Oil, Lactobacillus, Bifidobacterium, Sodium Hyaluronate, Ascorbic Acid, Hamamelis Virginiana Leaf Extract, Spirulina Platensis Extract, Calendula Officinalis Flower Extract, Tocopheryl Acetate, Retinyl Palmitate, Eucalyptus Globulus Leaf Oil, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Sodium Benzoate, Cocamidopropyl Betaine, Glycerin, Maltodextrin, Sodium Saccharin, Helianthus Annuus Seed Oil, Potassium Sorbate, BHT, Limonene, CI 16255.	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.
Experimental: Dental foam "WATER:DENT"; Aqua, Xylitol, PVP, PEG-40 Hydrogenated Castor Oil, Hippophae Rhamnoides Extract, Chamomilla Recutita Extract, Sodium Benzoate, Sodium Lauryl Sulfate, Aroma, Propylene Glycol, Olaflur, Potassium Sorbate, Sodium Phosphate, Disodium Phosphate, Menthol, Bisabolol, Menthyl Lactate, PPG-26 Buteth-26, Sodium Saccharin, Sodium Methylparaben, Citric Acid, Limonene.	Drug: 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.
Experimental: Spray "BUCCOTHERM"; Aqua (Castéra-Verduzan Thermal Spring water), Alcohol, Xylitol, Glycerin, Camellia sinensis leaf water, Mentha piperita leaf water, Hydrogenated starch hydrolysate, Aqua, Aroma, Limonene, Benzyl alcohol, Dehydroacetic acid.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): January 25, 2024
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: salivary pH; Coca-cola; salivary buffer capacity; oral foams
• Other Study ID Numbers: 18081215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No