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NCT Number: NCT05793099

Effect of 5% Aqueous Propolis in Salivary and Dental Plaque pH in Children

This study aims to investigate the changes in saliva and dental plaque pH after consuming sugar-free chewing gum containing 5% of aqueous propolis in children aged between 8-11 years. The studied sample will be divided into two groups: Group A (Control group) placebo chewing gum, and Group B (Experimental group) aqueous propolis chewing gum. All children will experience both types of chewing gum with an interval of 1 week between the two studied groups.

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Key information

Conditions

Child Dental Deposits Dental Plaque Saliva Stomatognathic Diseases Tooth Diseases

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, Syria

About this study

This study will evaluate saliva and dental plaque pH after consuming 10% sucrose solution and then each child will test each of the two types of gum (aqueous propolis 5% and placebo gum) so that the child himself is the control and tested sample together, according to the following order:

  • In the first visit: the pH of saliva and dental plaque will be measured (before giving the sucrose solution, while chewing one of the two types of gum, and after giving the sucrose solution).
  • In the second visit: after a week, the pH of saliva and dental plaque will be measured (before giving the sucrose solution, while chewing the other types of gum, and after giving the sucrose solution).)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children have mixed occlusion.
  • Integrity of the buccal surfaces of the reference teeth (16, 21, 26, 36, 41, 46) from caries and developmental disorders
  • Children with DMFS ≥5 according to WHO guidelines and standards.

Exclusion criteria

  • Systematic or mental disorders
  • Medications that may affect the salivary flow rate or composition.
  • Allergy to natural sugar substitutes.
  • Children who wear fixed or removable orthodontic appliances.
  • Children who have the habit of daily use of sugar substitute products.

Treatment and study plan

Effect of aqueous propolis gums in salivary and dental plaque pH in children

Other

The child will be given a 10% sucrose solution, and the salivary pH will be measured before and after giving sucrose solution (Baseline) and then the child will be given aqueous propolis gum to chew for 15 minutes to stimulate salivation. The saliva pH will be measured by taking a sample of the patient's saliva (3ml) while chewing the gum in the mouth in a disposable container and then saliva pH will be measured.

Dental plaque pH also will be measured before and after administration of a 10% sucrose solution (Baseline), and then 15 minutes after chewing aqueous propolis gum dental plaque will be collected using the "plaque collection" technique from the 6 buccal surfaces of teeth 16,21,26,36,41,46 using a sterile excavator. The sample will be mixed with 0.05 ml of distilled water until it dissolves and then dental plaque pH will be measured.

Effect of placebo gums in salivary and dental plaque pH in children

Other

The child will be given a 10% sucrose solution, and the salivary pH will be measured before and after giving sucrose solution (Baseline) and then the child will be given placebo gum to chew for 15 minutes to stimulate salivation. The saliva pH will be measured by taking a sample of the patient's saliva (3ml) while chewing the gum in the mouth in a disposable container and then saliva pH will be measured.

Dental plaque pH also will be measured before and after administration of a 10% sucrose solution (Baseline), and then 15 minutes after chewing placebo gum dental plaque will be collected using the "plaque collection" technique from the 6 buccal surfaces of teeth 16,21,26,36,41,46 using a sterile excavator. The sample will be mixed with 0.05 ml of distilled water until it dissolves and then dental plaque pH will be measured.

Primary outcomes

  1. Saliva pH measurement

    Time frame: 5 minutes after chewing gum.

    saliva pH will be measured by using saliva pH meter.

  2. Saliva pH measurement

    Time frame: 10 minutes after chewing gum.

    saliva pH will be measured by using saliva pH meter.

  3. Saliva pH measurement

    Time frame: 15 minutes after chewing gum.

    saliva pH will be measured by using saliva pH meter.

Secondary outcomes

  1. Dental plaque pH measurement

    Time frame: 15 minutes after chewing gum.

    Dental plaque will be Orion SA 720 pH/ISE Meter

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Effect of 5% Aqueous Propolis Added to Sugar-Free Chewing Gum in Salivary and Dental Plaque pH in Children (in Vivo Study)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2023
Registry last updated
Sep 29, 2023

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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