The Effect of Oral Sprays on Salivary pH

NCT ID: NCT06148662

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-01-25

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.

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.

Conditions

Oral Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

No intervention (negative control)

Negative control

Group Type: EXPERIMENTAL

No intervention (negative control)

Intervention Type: OTHER

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

Water (positive control)

Tap water

Group Type: EXPERIMENTAL

Water (positive control)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Dental foam "Biorepair PERIBIOMA"

Intervention Type: 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 "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.

Group Type: EXPERIMENTAL

Dental foam "WATER:DENT"

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Dental spray "BUCCOTHERM"

Intervention Type: 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.

Interventions

No intervention (negative control)

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

Intervention Type: 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.

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Dentistry of Sechenov University

Moscow, , Russia

Countries

Russia

References

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.

Reference Type: DERIVED

PMID: 38668005 (View on PubMed)

Other Identifiers

18081215

Identifier Type: -

Identifier Source: org_study_id