NCT05793099

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

March 20, 2023

Last Update Submit

September 27, 2023

Conditions

ChildSalivaDental Plaque

Keywords

Aqueous PropolisChewing gum

Outcome Measures

Primary Outcomes (3)

  • Saliva pH measurement

    saliva pH will be measured by using saliva pH meter.

    5 minutes after chewing gum.

  • Saliva pH measurement

    saliva pH will be measured by using saliva pH meter.

    10 minutes after chewing gum.

  • Saliva pH measurement

    saliva pH will be measured by using saliva pH meter.

    15 minutes after chewing gum.

Secondary Outcomes (1)

  • Dental plaque pH measurement

    15 minutes after chewing gum.

Study Arms (2)

Aqueous propolis 5% gum

EXPERIMENTAL

The children will be given aqueous propolis gums to chew for 15 minutes.

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

Placebo gum

PLACEBO COMPARATOR

The children will be given placebo gums gums to chew for 15 minutes.

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

Interventions

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

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.

Aqueous propolis 5% gum
Effect of placebo gums in salivary and dental plaque pH in childrenOTHER

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.

Placebo gum

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (5)

  • Kumar S, Sogi SH, Indushekar KR. Comparative evaluation of the effects of xylitol and sugar-free chewing gums on salivary and dental plaque pH in children. J Indian Soc Pedod Prev Dent. 2013 Oct-Dec;31(4):240-4. doi: 10.4103/0970-4388.121822.

    PMID: 24262397BACKGROUND

  • Gargouri W, Kammoun R, Elleuche M, Tlili M, Kechaou N, Ghoul-Mazgar S. Effect of xylitol chewing gum enriched with propolis on dentin remineralization in vitro. Arch Oral Biol. 2020 Apr;112:104684. doi: 10.1016/j.archoralbio.2020.104684. Epub 2020 Feb 19.

    PMID: 32120052BACKGROUND

  • Toors FA. [Chewing gum and dental health. Literature review]. Rev Belge Med Dent (1984). 1992;47(3):67-92. French.

    PMID: 1305985BACKGROUND

  • Monteil J, Hadj-Sassi A, Dargelos E, Guzman-Barrera N, Poque E, Leal-Calderon F. Method to prepare aqueous propolis dispersions based on phase separation. Food Chem. 2022 Sep 30;389:133072. doi: 10.1016/j.foodchem.2022.133072. Epub 2022 Apr 25.

    PMID: 35490523BACKGROUND

  • Abbasi AJ, Mohammadi F, Bayat M, Gema SM, Ghadirian H, Seifi H, Bayat H, Bahrami N. Applications of Propolis in Dentistry: A Review. Ethiop J Health Sci. 2018 Jul;28(4):505-512. doi: 10.4314/ejhs.v28i4.16.

    PMID: 30607063BACKGROUND

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Iman J Alahmad, DDs

    MSc student in Pedodontics, University of Damascus

    PRINCIPAL INVESTIGATOR

  • Shadi Azzawi, Phd

    Professor of Pedodontics, Department of Pedodontics, University of Damascus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

March 31, 2023

Study Start

December 16, 2022

Primary Completion

May 28, 2023

Study Completion

July 28, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)