The Effect of Oral Sprays on Salivary pH

NCT06148662 | Completed Phase 4

• 1 other identifier: 18081215
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Health

Keywords

Coca-cola; salivary buffer capacity; salivary pH; oral foams

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (5)

No intervention (negative control)

EXPERIMENTAL

Negative control

Other: No intervention (negative control)

Water (positive control)

EXPERIMENTAL

Tap water

Other: Water (positive control)

Dental foam "Biorepair PERIBIOMA"

EXPERIMENTAL

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"

Dental foam "WATER:DENT"

EXPERIMENTAL

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"

Spray "BUCCOTHERM"

EXPERIMENTAL

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"

Interventions

No intervention (negative control) OTHER

The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds.

No intervention (negative control)

Water (positive control) OTHER

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.

Water (positive control)

Dental foam "Biorepair PERIBIOMA" DRUG

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 "Biorepair PERIBIOMA"

Dental foam "WATER:DENT" DRUG

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 foam "WATER:DENT"

Dental spray "BUCCOTHERM" DRUG

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.

Spray "BUCCOTHERM"

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Institute of Dentistry of Sechenov University

Moscow, 121059, Russia

Location

Related Publications (1)

• Polyakova M, Egiazaryan A, Doroshina V, Zaytsev A, Malashin A, Babina K, Novozhilova N. The Effect of Oral Care Foams and a Spray on Salivary pH Changes after Exposure to Acidic Beverages in Young Adults. Dent J (Basel). 2024 Apr 3;12(4):93. doi: 10.3390/dj12040093.

  PMID: 38668005 DERIVED

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: December 1, 2023
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: March 5, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)