NCT03590977

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

July 5, 2018

Last Update Submit

July 17, 2018

Conditions

Keywords

Streptococcus Mutanslicoricechlorohexidinecaries index

Outcome Measures

Primary Outcomes (1)

  • salivary bacterial count

    streotococcus mutans bacterial count

    after one week

Study Arms (2)

licorice extract mouthwash

EXPERIMENTAL

administration of a mouthwash containing licorice as a preventive measure to high caries risk patients (faculty of pharmacy, cairo university)

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

Other: chlorohexidine mouthwash

Interventions

mouth rinse that contains a natural herbal licorice root extract used as a preventive measure that reduce caries index.

licorice extract mouthwash

mouth wash that contains chlorohexidine as an active component

chlorohexidine mouthwash

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years old
  • co-operative patients
  • not allergic to licorice
  • not allergic to chlorohexidine

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 27129589BACKGROUND
  • 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.

    PMID: 24021323BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • nancy helmy, Msc

    Faculty of Dentistry, Cairo univerisity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 18, 2018

Study Start

September 1, 2018

Primary Completion

August 30, 2019

Study Completion

October 1, 2019

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share