Dental CariesNCT03763578
Dental Caries Prevention by a Natural Product
A study testing Licorice in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
The objective is to conduct an RCT to evaluate the effectiveness of Licorice in comparison to standard caries preventive measures for the prevention of new carious lesions in high caries risk patients. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Licorice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Dec 2021
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with high caries risk,
- 18-25 years,
- Males or females,
- Medically free patients,
- Patients approving to participate in the study.
Who cannot join
- Patients who were on antibiotic therapy or corticosteroid therapy for 30 days before the examination,
- Patients had history of professional cleaning in the last 15 days,
- Patients with exposed pulp,
- Evidence of parafunctional habits,
- Patients with developmental dental anomalies,
- Patients undergoing or will start orthodontic treatment,
- Patients with removable prosthesis,
- Periapical Abscess or Fistula.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Conservative and Esthetic Dentistry Department-Faculty of Dentistry- Cairo University
Cairo, Choose Any State/Province, 002
About this study
Official title: Licorice Versus Standard Preventive Measures for the Prevention of Caries Incidence in Young Egyptian Adults: Randomized Controlled Trial
The objective is to conduct an RCT to evaluate the effectiveness of Licorice in comparison to standard caries preventive measures for the prevention of new carious lesions in high caries risk patients.
Read the detailed description
Research hypothesis (Null hypothesis):
The present clinical trial will be conducted to reject or accept the null hypothesis that using Licorice extract mouth wash in addition to standard preventive measures will not differ from using standard preventive measures alone in preventing incidence of new carious lesions.
PICOTS:
P: Population with high caries risk patients
I: Use of licorice.
I2: Use of chlorhexidine
C: Use of standard preventive measures (tooth brushing, tooth paste, interdental cleaning).
O.1: Primary outcome is incidence of new carious lesions
T: Time for measurement is 12 months
S: A Randomized controlled clinical trial (Parallel study)
- Conditions
- Dental Caries
- Being tested
- Licorice
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LicoriceOther
Also called Glycyrrhiza glabra Linn, Mulethi
Natural herbal product
| Study group | Role | What they receive |
|---|---|---|
| Licorice | Experimental | licorice is one of the natural products that is listed by the Food and Drug Administration (FDA) as GRAS (generally regarded as safe) when used as food flavoring and sweetening agent which has an antimicrobial, anti-inflammatory and antiviral activity. Receives: Other: Licorice |
| Chlorhexidine | Active comparator | The "gold standard" of oral therapeutics is Chlorhexidine due to its prolonged broad- spectrum antimicrobial effect. Receives: Other: Licorice |
| Control Group | No intervention | Participants in this group will follow only the standard preventive measures which is brushing twice a day after breakfast and before bed time and daily flossing interdentally before bed time. (No Mouthwash is used) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new carious lesions
Appearance of new carious lesions within the study duration
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Sep 2020
- Primary completion1 Dec 2020
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohammed Ahmed Mady, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763578
- Sponsor's protocol ID
- 18941
- Status last verified
- Feb 2022
- First submitted
- 10 Nov 2018
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Licorice Versus Standard Preventive Measures for the Prevention of Caries Incidence in Young Egyptian Adults: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03763578
- Acronym / sponsor ID
- 18941
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 4 Dec 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.
The objective is to conduct an RCT to evaluate the effectiveness of Licorice in comparison to standard caries preventive measures for the prevention of new carious lesions in high caries risk patients.
Detailed description
Research hypothesis (Null hypothesis):
The present clinical trial will be conducted to reject or accept the null hypothesis that using Licorice extract mouth wash in addition to standard preventive measures will not differ from using standard preventive measures alone in preventing incidence of new carious lesions.
PICOTS:
P: Population with high caries risk patients
I: Use of licorice.
I2: Use of chlorhexidine
C: Use of standard preventive measures (tooth brushing, tooth paste, interdental cleaning).
O.1: Primary outcome is incidence of new carious lesions
T: Time for measurement is 12 months
S: A Randomized controlled clinical trial (Parallel study)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Licorice | Experimental | Other: Licoricelicorice is one of the natural products that is listed by the Food and Drug Administration (FDA) as GRAS (generally regarded as safe) when used as food flavoring and sweetening agent which has an antimicrobial, anti-inflammatory and antiviral activity. |
| Chlorhexidine | Active comparator | Other: LicoriceThe "gold standard" of oral therapeutics is Chlorhexidine due to its prolonged broad- spectrum antimicrobial effect. |
| Control Group | No intervention | –Participants in this group will follow only the standard preventive measures which is brushing twice a day after breakfast and before bed time and daily flossing interdentally before bed time. (No Mouthwash is used) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with high caries risk,
- 18-25 years,
- Males or females,
- Medically free patients,
- Patients approving to participate in the study.
Key exclusion criteria (8 listed)
- Patients who were on antibiotic therapy or corticosteroid therapy for 30 days before the examination,
- Patients had history of professional cleaning in the last 15 days,
- Patients with exposed pulp,
- Evidence of parafunctional habits,
- Patients with developmental dental anomalies,
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 |
|---|---|---|
| LicoriceAlso: Glycyrrhiza glabra Linn, MulethiNatural herbal product | Other | Chlorhexidine, Licorice |
Primary outcome
Incidence of new carious lesions
Time frame: 12 months
Appearance of new carious lesions within the study duration
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 8 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Licorice in people with Dental Caries, run by Cairo University at 1 site in Egypt.
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 5 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: finished, as of the sponsor's last update on 8 Feb 2022. 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?
Incidence of new carious lesions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2022.