- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03590977
Efficacy of Licorice on Reducing Salivary Streptococcus Mutans Versus Chlorohexidine in Caries Risk Patients
July 17, 2018 updated by: Nancy Helmy Blamon Mikhael, Cairo University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: nancy helmy, Msc
- Phone Number: 002 01002715841
- Email: nancy.helmy@dentistry.cu.edu.eg
Study Contact Backup
- Name: sherine hafez, Phd
- Phone Number: 002 01099296591
- Email: sherine.hafez@dentistry.cu.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- over 18 years old
- co-operative patients
- not allergic to licorice
- not allergic to chlorohexidine
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: licorice extract mouthwash
administration of a mouthwash containing licorice as a preventive measure to high caries risk patients (faculty of pharmacy, cairo university)
|
mouth rinse that contains a natural herbal licorice root extract used as a preventive measure that reduce caries index.
|
PLACEBO_COMPARATOR: chlorohexidine mouthwash
administration of chlorohexidine 0.2% in 1:1 diluation mouthwash that is broad spectrum antimicrobial activity to high caries risk patients
|
mouth wash that contains chlorohexidine as an active component
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
salivary bacterial count
Time Frame: after one week
|
streotococcus mutans bacterial count
|
after one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: nancy helmy, Msc, Faculty of Dentistry, Cairo univerisity
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Jain 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 1, 2018
Primary Completion (ANTICIPATED)
August 30, 2019
Study Completion (ANTICIPATED)
October 1, 2019
Study Registration Dates
First Submitted
July 5, 2018
First Submitted That Met QC Criteria
July 17, 2018
First Posted (ACTUAL)
July 18, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 18, 2018
Last Update Submitted That Met QC Criteria
July 17, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2018-07-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Caries, Dental
-
Ain Shams UniversityCompletedPulpitis | Caries | Caries,Dental | Reversible Pulpitis | Caries Class I | Caries; DentinEgypt
-
National University of San Marcos, PeruNot yet recruitingPit and Fissure Caries | Caries,Dental | Sealant DentalPeru
-
University of MinnesotaCompletedUsing Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood CariesCaries | Caries,DentalUnited States
-
Hue University of Medicine and PharmacyRecruitingOcclusal Caries | Caries,Dental | Caries; InitialVietnam
-
3MUniversity of MichiganActive, not recruiting
-
Rawda Hesham Abd ElAzizRecruitingCaries,Dental | Caries Class IIEgypt
-
The University of Texas Health Science Center,...National Institute of Dental and Craniofacial Research (NIDCR)RecruitingCaries,DentalUnited States
-
Federal University of PelotasRecruiting
-
Kompetansesenteret Tannhelse Midt (TkMidt)Karolinska Institutet; University of Bergen; Norwegian University of Science... and other collaboratorsActive, not recruiting
Clinical Trials on licorice extract mouthwash
-
Cairo UniversityUnknown
-
Alexandria UniversityNot yet recruiting
-
Cairo UniversityCompletedHigh Caries Risk Patients | Streptococcus MutansEgypt
-
HaEmek Medical Center, IsraelUnknownDiabetes Mellitus | AtherosclerosisIsrael
-
Shiraz University of Medical SciencesCompletedAcute StrokeIran, Islamic Republic of
-
F&C Licorice LtdUnknownVaginal Dryness | Postmenopausal SymptomsIsrael
-
Egyptian Biomedical Research NetworkCompleted
-
Government Dental College and Research Institute...Himalaya Drug Company Research and Development, Makali, Bangalore, IndiaCompletedDentinal Hypersensitivity
-
Cairo UniversityNot yet recruiting