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Completed

NCT Number: NCT06148662

The Effect of Oral Sprays on Salivary pH

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

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Key information

Conditions

Oral Health

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Dentistry of Sechenov University

Moscow, 121059, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention (negative control)

Other

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

Water (positive control)

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"

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"

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.

Dental spray "BUCCOTHERM"

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.

Primary outcomes

  1. The time required for salivary pH recovery after Coca-Cola consumption

    Time frame: 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.

  2. The time required for salivary pH recovery after Coca-Cola consumption followed by oral sprays application

    Time frame: 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.

  3. Minimal value of salivary pH after Coca-Cola consumption

    Time frame: 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.

  4. minimal value of salivary pH recovery after Coca-Cola consumption followed by oral sprays application

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 28, 2023
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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