ChildNCT05793099
Effect of 5% Aqueous Propolis in Salivary and Dental Plaque pH in Children
A study testing Effect of aqueous propolis gums in salivary and dental plaque pH in children in people with Child and Saliva, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Saliva, Dental Plaque
- What is being tested?
- Effect of aqueous propolis gums in salivary and dental plaque pH in children
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- 16 Dec 2022to 28 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 5% Aqueous Propolis Added to Sugar-Free Chewing Gum in Salivary and Dental Plaque pH in Children (in Vivo Study)
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.
Read the detailed description
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).)
- Conditions
- Child, Saliva, Dental Plaque
- Being tested
- Effect of aqueous propolis gums in salivary and dental plaque pH in children, Effect of placebo gums in salivary and dental plaque pH in children
- Keywords
- Aqueous Propolis, Chewing gum
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Aqueous propolis 5% gum | Experimental | The children will be given aqueous propolis gums to chew for 15 minutes. Receives: 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. Receives: Other: Effect of placebo gums in salivary and dental plaque pH in children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva pH measurement
saliva pH will be measured by using saliva pH meter.
Measured: 5 minutes after chewing gum.
Saliva pH measurement
saliva pH will be measured by using saliva pH meter.
Measured: 10 minutes after chewing gum.
Saliva pH measurement
saliva pH will be measured by using saliva pH meter.
Measured: 15 minutes after chewing gum.
Secondary outcomes (1)
Dental plaque pH measurement
Dental plaque will be Orion SA 720 pH/ISE Meter
Measured: 15 minutes after chewing gum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start16 Dec 2022
- Primary completion28 May 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iman J Alahmad, DDs, Principal investigator, MSc student in Pedodontics, University of DamascusShadi Azzawi, Phd, Study director, Professor of Pedodontics, Department of Pedodontics, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793099
- Sponsor's protocol ID
- UDDS-Pedo-05-2023
- Status last verified
- Sep 2023
- First submitted
- 20 Mar 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24262397Gargouri 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.
PubMed 32120052Toors FA. [Chewing gum and dental health. Literature review]. Rev Belge Med Dent (1984). 1992;47(3):67-92. French.
PubMed 1305985Monteil 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.
PubMed 35490523Abbasi 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.
PubMed 30607063
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 5% Aqueous Propolis Added to Sugar-Free Chewing Gum in Salivary and Dental Plaque pH in Children (in Vivo Study)
- ClinicalTrials.gov ID
- NCT05793099
- Acronym / sponsor ID
- UDDS-Pedo-05-2023
- Conditions
- Child, Saliva, Dental Plaque
- Keywords
- Aqueous Propolis, Chewing gum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 28 May 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aqueous propolis 5% gum | Experimental | Other: Effect of aqueous propolis gums in salivary and dental plaque pH in childrenThe children will be given aqueous propolis gums to chew for 15 minutes. |
| Placebo gum | Placebo comparator | Other: Effect of placebo gums in salivary and dental plaque pH in childrenThe children will be given placebo gums gums to chew for 15 minutes. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect of aqueous propolis gums in salivary and dental plaque pH in childrenThe 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. | Other | Aqueous propolis 5% gum |
| Effect of placebo gums in salivary and dental plaque pH in childrenThe 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. | Other | Placebo gum |
Primary outcome
Saliva pH measurement
Time frame: 5 minutes after chewing gum.
saliva pH will be measured by using saliva pH meter.
Saliva pH measurement
Time frame: 10 minutes after chewing gum.
saliva pH will be measured by using saliva pH meter.
Saliva pH measurement
Time frame: 15 minutes after chewing gum.
saliva pH will be measured by using saliva pH meter.
1 secondary outcome
Dental plaque pH measurement
Time frame: 15 minutes after chewing gum.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 24262397Kumar 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.
- Background: PubMed 32120052Gargouri 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.
- Background: PubMed 1305985Toors FA. [Chewing gum and dental health. Literature review]. Rev Belge Med Dent (1984). 1992;47(3):67-92. French.
- Background: PubMed 35490523Monteil 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.
- Background: PubMed 30607063Abbasi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iman J Alahmad, DDs principal investigator
MSc student in Pedodontics, University of Damascus
Shadi Azzawi, Phd study director
Professor of Pedodontics, Department of Pedodontics, University of Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of aqueous propolis gums in salivary and dental plaque pH in children in people with Child and Saliva, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saliva pH measurement (time frame: 5 minutes after chewing gum.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05793099, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.