The Effect of Oral Sprays on Salivary pH
- Conditions
- Oral Health
- Interventions
- Other: Water (positive control)Other: No intervention (negative control)Drug: Dental foam "Biorepair PERIBIOMA"Drug: Dental spray "BUCCOTHERM"
- Registration Number
- NCT06148662
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Water (positive control) Water (positive control) Tap water No intervention (negative control) No intervention (negative control) Negative control Dental foam "Biorepair PERIBIOMA" 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. Spray "BUCCOTHERM" Dental 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.
- Primary Outcome Measures
Name Time Method The time required for salivary pH recovery after Coca-Cola consumption 1 hour 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.
The time required for salivary pH recovery after Coca-Cola consumption followed by oral sprays application 1 hour 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.
Minimal value of salivary pH after Coca-Cola consumption 1 hour 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.
minimal value of salivary pH recovery after Coca-Cola consumption followed by oral sprays application 1 hour 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institute of Dentistry of Sechenov University
🇷🇺Moscow, Russian Federation