The Effect of Oral Sprays on Salivary pH

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oral Health

Intervention / Treatment
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* Other: No intervention (negative control)
* Other: Water (positive control)
* Drug: Dental foam Biorepair PERIBIOMA
* Drug: Dental foam WATER:DENT
* Drug: Dental spray BUCCOTHERM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No intervention (negative control)<br>Negative control | Other: No intervention (negative control)<br>* The participants will be asked to hold 20 ml of coca-cola in their mouth for 30 seconds.<br>|
| Experimental: Water (positive control)<br>Tap water | Other: Water (positive control)<br>* 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.<br>|
| Experimental: Dental foam Biorepair PERIBIOMA<br>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<br>* 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.<br>|
| Experimental: Dental foam WATER:DENT<br>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<br>* 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.<br>|
| Experimental: Spray BUCCOTHERM<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coca-cola, salivary buffer capacity, salivary pH, oral foams