Caries, DentalNCT03553628

Using a Mouthwash Containing Propolis, Clove Oil and Chlorhexidine to Improve the Caries Risk of High Risk Patients

A study testing Chlorhexidine, Propolis and Clove Oil mouthwash and Chlorhexidine mouthwash in people with Caries, Dental and Risk Reduction, run by Moataz Gamal Ali Abdul-Maksoud Konsouh at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is conducted to determine if using a mouthwash containing propolis, clove oil and chlorhexidine will improve the caries risk of high risk patients in comparison to using a mouthwash containing chlorhexidine only. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Caries, Dental, Risk Reduction
What is being tested?: Chlorhexidine, Propolis and Clove Oil mouthwash and Chlorhexidine mouthwash
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteEgypt
Study dates: 1 Aug 2018to 1 Mar 2019
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients should be over 18 years of age.
Patients should be with high caries risk assessment.

Who cannot join

Patients with a compromised medical history.
Severe or active periodontal disease.
Patients with a diseased salivary gland
History of allergies or other adverse reactions to chlorhexidine, propolis, bee stings, or clove
Patients on any antibiotics during the past month

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Conservative Dentistry Department Out-Patient Clinic
Cairo, 12613

Other trials in Egypt

About this study

Official title: Using a Mouthwash Containing Propolis, Clove Oil and Chlorhexidine to Improve the Caries Risk of High Risk Patients: Randomized Clinical Trial

Read the detailed description

A total of 64 patients will be assigned in this study. Patients will be randomly divided into two groups according to type of mouthwash (A) where group A1 patients will use chlorhexidine mouthwash as control group while group A2 patients will use chlorhexidine with propolis and clove oil mouthwash as intervention group with 32 patients in each group. Each group will be further divided into two groups according to times of application (T) where T1 represents patients using the mouthwash once daily for one week every month for 6 months and T2 where patients will use the mouthwash twice daily for one week every month for 6 months with 16 patients in each subgroup.

Conditions: Caries, Dental, Risk Reduction
Being tested: Chlorhexidine, Propolis and Clove Oil mouthwash, Chlorhexidine mouthwash
Keywords: dental caries, propolis, chlorhexidine, clove oil, bee wax
Medical subject headings: Dental Caries, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chlorhexidine, Propolis and Clove Oil mouthwashOther
Chlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash
Chlorhexidine mouthwashOther
Chlorhexidine HCL 0.12% mouthwash

Study groups in NCT03553628
Study group	Role	What they receive
Chlorhexidine Once Daily	Active comparator	Chlorhexidine HCL 0.12% mouthwash to be used once daily for one week each month for six months Receives: Other: Chlorhexidine mouthwash
Chlorhexidine Twice Daily	Active comparator	Chlorhexidine HCL 0.12% mouthwash to be used twice daily for one week each month for six months Receives: Other: Chlorhexidine mouthwash
Propolis Once Daily	Experimental	Chlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash to be used once daily for one week each month for six months Receives: Other: Chlorhexidine, Propolis and Clove Oil mouthwash
Propolis Twice Daily	Experimental	Chlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash to be used twice daily for one week each month for six months Receives: Other: Chlorhexidine, Propolis and Clove Oil mouthwash

What is being measured

The primary outcome is the main question the study is designed to answer.

Caries Risk Assessment
Patient caries risk assessment will be measured using the cariogram model
Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20181 Mar 2019

First posted12 Jun 2018
Study start1 Aug 2018
Primary completion31 Jan 2019
Study completion1 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Caries, DentalStudies 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
Model description: A total of 64 patients will be assigned in this study. Patients will be randomly divided into two groups according to type of mouthwash (A) where group A1 patients will use chlorhexidine mouthwash as control group while group A2 patients will use chlorhexidine with propolis and clove oil mouthwash as intervention group with 32 patients in each group. Each group will be further divided into two groups according to times of application (T) where T1 represents patients using the mouthwash once daily for one week every month for 6 months and T2 where patients will use the mouthwash twice daily for one week every month for 6 months with 16 patients in each subgroup.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03553628
Sponsor's protocol ID: oper252215
Status last verified: Dec 2020
First submitted: 30 May 2018
Last updated: 5 Jan 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alian AY, McNally ME, Fure S, Birkhed D. Assessment of caries risk in elderly patients using the Cariogram model. J Can Dent Assoc. 2006 Jun;72(5):459-63.
PubMed 16772072
Autio-Gold J. The role of chlorhexidine in caries prevention. Oper Dent. 2008 Nov-Dec;33(6):710-6. doi: 10.2341/08-3.
PubMed 19051866
Duailibe SA, Goncalves AG, Ahid FJ. Effect of a propolis extract on Streptococcus mutans counts in vivo. J Appl Oral Sci. 2007 Oct;15(5):420-3. doi: 10.1590/s1678-77572007000500009.
PubMed 19089172
Eley BM. Antibacterial agents in the control of supragingival plaque--a review. Br Dent J. 1999 Mar 27;186(6):286-96. doi: 10.1038/sj.bdj.4800090.
PubMed 10230103
Grossman, E., Retter, G., Sturzenberger, O. P., Rosa, M. D. La, Dickinson, T. D., Ferretti, G. A., … Meckel, A. H. (1986). Six-month Study of the Effects of a Chlorhexidine Mouthrinse on Gingivitis in Adults. Journal of Periodontal Research, 33-43.
Hegde KS, Bhat SS, Rao A, Sain S. Effect of Propolis on Streptococcus mutans Counts: An in vivo Study. Int J Clin Pediatr Dent. 2013 Jan;6(1):22-5. doi: 10.5005/jp-journals-10005-1180. Epub 2013 Apr 26.
PubMed 25206182
Kim MJ, Kim CS, Kim BH, Ro SB, Lim YK, Park SN, Cho E, Ko JH, Kwon SS, Ko YM, Kook JK. Antimicrobial effect of Korean propolis against the mutans streptococci isolated from Korean. J Microbiol. 2011 Feb;49(1):161-4. doi: 10.1007/s12275-011-1002-8. Epub 2011 Mar 3.
PubMed 21369995
Liberio SA, Pereira AL, Araujo MJ, Dutra RP, Nascimento FR, Monteiro-Neto V, Ribeiro MN, Goncalves AG, Guerra RN. The potential use of propolis as a cariostatic agent and its actions on mutans group streptococci. J Ethnopharmacol. 2009 Aug 17;125(1):1-9. doi: 10.1016/j.jep.2009.04.047. Epub 2009 May 5.
PubMed 19422903
Anauate Netto C, Marcucci MC, Paulino N, Anido-Anido A, Amore R, de Mendonca S, Borelli Neto L, Bretz WA. Effects of typified propolis on mutans streptococci and lactobacilli: a randomized clinical trial. Braz Dent Sci. 2013 Apr 1;16(2):31-36. doi: 10.14295/bds.2013.v16i2.879.
PubMed 24494174
SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
PubMed 14158464

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using a Mouthwash Containing Propolis, Clove Oil and Chlorhexidine to Improve the Caries Risk of High Risk Patients: Randomized Clinical Trial
ClinicalTrials.gov ID: NCT03553628
Acronym / sponsor ID: oper252215
Conditions: Caries, Dental, Risk Reduction
Keywords: dental caries, propolis, chlorhexidine, clove oil, bee wax
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Moataz Gamal Ali Abdul-Maksoud KonsouhUniversity, hospital or other
Collaborators: Cairo University
Study start: 1 Aug 2018 (actual)
Primary completion: 31 Jan 2019 (actual)
Study completion: 1 Mar 2019 (actual)
First posted: 12 Jun 2018 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: A total of 64 patients will be assigned in this study. Patients will be randomly divided into two groups according to type of mouthwash (A) where group A1 patients will use chlorhexidine mouthwash as control group while group A2 patients will use chlorhexidine with propolis and clove oil mouthwash as intervention group with 32 patients in each group. Each group will be further divided into two groups according to times of application (T) where T1 represents patients using the mouthwash once daily for one week every month for 6 months and T2 where patients will use the mouthwash twice daily for one week every month for 6 months with 16 patients in each subgroup.

Arm	Type	Receives
Chlorhexidine Once Daily	Active comparator	Other: Chlorhexidine mouthwashChlorhexidine HCL 0.12% mouthwash to be used once daily for one week each month for six months
Chlorhexidine Twice Daily	Active comparator	Other: Chlorhexidine mouthwashChlorhexidine HCL 0.12% mouthwash to be used twice daily for one week each month for six months
Propolis Once Daily	Experimental	Other: Chlorhexidine, Propolis and Clove Oil mouthwashChlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash to be used once daily for one week each month for six months
Propolis Twice Daily	Experimental	Other: Chlorhexidine, Propolis and Clove Oil mouthwashChlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash to be used twice daily for one week each month for six months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients should be over 18 years of age.
Patients should be with high caries risk assessment.

Key exclusion criteria (5 listed)

Patients with a compromised medical history.
Severe or active periodontal disease.
Patients with a diseased salivary gland
History of allergies or other adverse reactions to chlorhexidine, propolis, bee stings, or clove
Patients on any antibiotics during the past month

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
Chlorhexidine, Propolis and Clove Oil mouthwashChlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash	Other	Propolis Once Daily, Propolis Twice Daily
Chlorhexidine mouthwashChlorhexidine HCL 0.12% mouthwash	Other	Chlorhexidine Once Daily, Chlorhexidine Twice Daily

Primary outcome

Caries Risk Assessment
Time frame: 6 month
Patient caries risk assessment will be measured using the cariogram model

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 5 Jan 2021.
Background: PubMed 16772072Alian AY, McNally ME, Fure S, Birkhed D. Assessment of caries risk in elderly patients using the Cariogram model. J Can Dent Assoc. 2006 Jun;72(5):459-63.
Background: PubMed 19051866Autio-Gold J. The role of chlorhexidine in caries prevention. Oper Dent. 2008 Nov-Dec;33(6):710-6. doi: 10.2341/08-3.
Background: PubMed 19089172Duailibe SA, Goncalves AG, Ahid FJ. Effect of a propolis extract on Streptococcus mutans counts in vivo. J Appl Oral Sci. 2007 Oct;15(5):420-3. doi: 10.1590/s1678-77572007000500009.
Background: PubMed 10230103Eley BM. Antibacterial agents in the control of supragingival plaque--a review. Br Dent J. 1999 Mar 27;186(6):286-96. doi: 10.1038/sj.bdj.4800090.
BackgroundGrossman, E., Retter, G., Sturzenberger, O. P., Rosa, M. D. La, Dickinson, T. D., Ferretti, G. A., … Meckel, A. H. (1986). Six-month Study of the Effects of a Chlorhexidine Mouthrinse on Gingivitis in Adults. Journal of Periodontal Research, 33-43.
Background: PubMed 25206182Hegde KS, Bhat SS, Rao A, Sain S. Effect of Propolis on Streptococcus mutans Counts: An in vivo Study. Int J Clin Pediatr Dent. 2013 Jan;6(1):22-5. doi: 10.5005/jp-journals-10005-1180. Epub 2013 Apr 26.
Background: PubMed 21369995Kim MJ, Kim CS, Kim BH, Ro SB, Lim YK, Park SN, Cho E, Ko JH, Kwon SS, Ko YM, Kook JK. Antimicrobial effect of Korean propolis against the mutans streptococci isolated from Korean. J Microbiol. 2011 Feb;49(1):161-4. doi: 10.1007/s12275-011-1002-8. Epub 2011 Mar 3.
Background: PubMed 19422903Liberio SA, Pereira AL, Araujo MJ, Dutra RP, Nascimento FR, Monteiro-Neto V, Ribeiro MN, Goncalves AG, Guerra RN. The potential use of propolis as a cariostatic agent and its actions on mutans group streptococci. J Ethnopharmacol. 2009 Aug 17;125(1):1-9. doi: 10.1016/j.jep.2009.04.047. Epub 2009 May 5.
Background: PubMed 24494174Anauate Netto C, Marcucci MC, Paulino N, Anido-Anido A, Amore R, de Mendonca S, Borelli Neto L, Bretz WA. Effects of typified propolis on mutans streptococci and lactobacilli: a randomized clinical trial. Braz Dent Sci. 2013 Apr 1;16(2):31-36. doi: 10.14295/bds.2013.v16i2.879.
Background: PubMed 14158464SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
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.

Mohammad A Ezzat, Ph.D. study director

Cairo University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 5 Jan 2021. 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 Egypt. 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. 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?

Caries Risk Assessment (time frame: 6 month). 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 NCT03553628, which also lists 10 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 5 Jan 2021.