Caries, DentalNCT03590977
Efficacy of Licorice on Reducing Salivary Streptococcus Mutans Versus Chlorohexidine in Caries Risk Patients
A study testing licorice extract mouthwash and chlorohexidine mouthwash in people with Caries, Dental, run by Cairo University.
Trial summary
To compare the effect of a natural herbal licorice containing preventive measure alternative to chlorohexidine preventive measure to decrease the effect of streptococcus mutans. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental
- What is being tested?
- licorice extract mouthwash and chlorohexidine mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Oct 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 18 years old
- co-operative patients
- not allergic to licorice
- not allergic to chlorohexidine
Who cannot join
- pregnancy
- allergic patients to licorice
- allergic patients to chlorohexidine
- lack of compliance
- evidence of parafunctional habits
- patients with periodontal disease
- xerostomia
- participants that receive any microbial agent two weeks prior to the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation the Efficacy of a Herbal Licorice on Reducing Salivary Streptococcus Mutans Levels (A Randomized Clinical Trial)
To compare the effect of a natural herbal licorice containing preventive measure alternative to chlorohexidine preventive measure to decrease the effect of streptococcus mutans.
Read the detailed description
A total number of fifty-two patients will be enrolled in the study. They will be divided into two groups: study group and control group. Study group will be subjected to licorice mouthwash and the control will be subjected to chlorohexidine mouth wash. Salivary bacterial count will be evaluated for both groups.
- Conditions
- Caries, Dental
- Being tested
- licorice extract mouthwash, chlorohexidine mouthwash
- Keywords
- Streptococcus Mutans, licorice, chlorohexidine, caries index
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
licorice extract mouthwashOther
mouth rinse that contains a natural herbal licorice root extract used as a preventive measure that reduce caries index.
chlorohexidine mouthwashOther
mouth wash that contains chlorohexidine as an active component
| Study group | Role | What they receive |
|---|---|---|
| licorice extract mouthwash | Experimental | administration of a mouthwash containing licorice as a preventive measure to high caries risk patients (faculty of pharmacy, cairo university) Receives: Other: licorice extract mouthwash |
| chlorohexidine mouthwash | Placebo comparator | administration of chlorohexidine 0.2% in 1:1 diluation mouthwash that is broad spectrum antimicrobial activity to high caries risk patients Receives: Other: chlorohexidine mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary bacterial count
streotococcus mutans bacterial count
Measured: after one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Sep 2018 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Caries, DentalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Helmy Blamon Mikhael, Cairo University
- Investigators
- nancy helmy, Msc, Principal investigator, Faculty of Dentistry, Cairo univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590977
- Sponsor's protocol ID
- CEBD-CU-2018-07-5
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almaz ME, Sonmez IS, Okte Z, Oba AA. Efficacy of a sugar-free herbal lollipop for reducing salivary Streptococcus mutans levels: a randomized controlled trial. Clin Oral Investig. 2017 Apr;21(3):839-845. doi: 10.1007/s00784-016-1827-y. Epub 2016 Apr 30.
PubMed 27129589Jain E, Pandey RK, Khanna R. Liquorice root extracts as potent cariostatic agents in pediatric practice. J Indian Soc Pedod Prev Dent. 2013 Jul-Sep;31(3):146-52. doi: 10.4103/0970-4388.117964.
PubMed 24021323
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Efficacy of a Herbal Licorice on Reducing Salivary Streptococcus Mutans Levels (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03590977
- Acronym / sponsor ID
- CEBD-CU-2018-07-5
- Conditions
- Caries, Dental
- Keywords
- Streptococcus Mutans, licorice, chlorohexidine, caries index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 18 Jul 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.
To compare the effect of a natural herbal licorice containing preventive measure alternative to chlorohexidine preventive measure to decrease the effect of streptococcus mutans.
Detailed description
A total number of fifty-two patients will be enrolled in the study. They will be divided into two groups: study group and control group. Study group will be subjected to licorice mouthwash and the control will be subjected to chlorohexidine mouth wash. Salivary bacterial count will be evaluated for both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| licorice extract mouthwash | Experimental | Other: licorice extract mouthwashadministration of a mouthwash containing licorice as a preventive measure to high caries risk patients (faculty of pharmacy, cairo university) |
| chlorohexidine mouthwash | Placebo comparator | Other: chlorohexidine mouthwashadministration of chlorohexidine 0.2% in 1:1 diluation mouthwash that is broad spectrum antimicrobial activity to high caries risk patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 18 years old
- co-operative patients
- not allergic to licorice
- not allergic to chlorohexidine
Key exclusion criteria (8 listed)
- pregnancy
- allergic patients to licorice
- allergic patients to chlorohexidine
- lack of compliance
- evidence of parafunctional habits
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 |
|---|---|---|
| licorice extract mouthwashmouth rinse that contains a natural herbal licorice root extract used as a preventive measure that reduce caries index. | Other | licorice extract mouthwash |
| chlorohexidine mouthwashmouth wash that contains chlorohexidine as an active component | Other | chlorohexidine mouthwash |
Primary outcome
salivary bacterial count
Time frame: after one week
streotococcus mutans bacterial count
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Background: PubMed 27129589Almaz ME, Sonmez IS, Okte Z, Oba AA. Efficacy of a sugar-free herbal lollipop for reducing salivary Streptococcus mutans levels: a randomized controlled trial. Clin Oral Investig. 2017 Apr;21(3):839-845. doi: 10.1007/s00784-016-1827-y. Epub 2016 Apr 30.
- Background: PubMed 24021323Jain E, Pandey RK, Khanna R. Liquorice root extracts as potent cariostatic agents in pediatric practice. J Indian Soc Pedod Prev Dent. 2013 Jul-Sep;31(3):146-52. doi: 10.4103/0970-4388.117964.
- 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.
nancy helmy, Msc principal investigator
Faculty of Dentistry, Cairo univerisity
Questions about this trial
What is this clinical trial studying?
A study testing licorice extract mouthwash and chlorohexidine mouthwash in people with Caries, Dental, run by Cairo University.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nancy helmy, Msc (01002715841 ext. 002, nancy.helmy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary bacterial count (time frame: after one week). 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 NCT03590977, which also lists 2 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 18 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.