The Effect of Oral Sprays on Salivary pH

I.M. Sechenov First Moscow State Medical University

Status and phase: Completed; Phase 4

Conditions: Oral Health

Treatments: Drug: Dental foam "Biorepair PERIBIOMA"; Drug: Dental foam "WATER:DENT"; Drug: Dental spray "BUCCOTHERM"; Other: No intervention (negative control); Other: Water (positive control)

Study type: Interventional

Funder types: Other

Identifiers

NCT06148662

18081215

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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33 participants in 5 patient groups

No intervention (negative control)

Experimental group

Description:

Negative control

Treatment:

Other: No intervention (negative control)

Water (positive control)

Experimental group

Description:

Tap water

Treatment:

Other: Water (positive control)

Dental foam "Biorepair PERIBIOMA"

Experimental group

Description:

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.

Treatment:

Drug: Dental foam "Biorepair PERIBIOMA"

Dental foam "WATER:DENT"

Experimental group

Description:

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.

Treatment:

Drug: Dental foam "WATER:DENT"

Spray "BUCCOTHERM"

Experimental group

Description:

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.

Treatment:

Drug: Dental spray "BUCCOTHERM"