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The Effect of Oral Sprays on Salivary pH

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06148662
Enrollment
33
Registered
2023-11-28
Start date
2023-12-01
Completion date
2024-01-25
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health

Keywords

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

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.

Interventions

OTHERNo intervention (negative control)

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

OTHERWater (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.

DRUGDental 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.

DRUGDental 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.

DRUGDental 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.

Sponsors

I.M. Sechenov First Moscow State Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The time required for salivary pH recovery after Coca-Cola consumption1 hourThe 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 application1 hourThe 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 consumption1 hourThe 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 application1 hourThe 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.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026