NCT03623048

Brief Summary

Evaluate the effect of propolis extract mouthwash and pomegranate extract mouthwash on taste alteration, salivary pH and antibacterial activity against streptococcus mutans in high caries risk patients.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

1 month

First QC Date

August 7, 2018

Last Update Submit

September 8, 2018

Conditions

Decay, Dental

Outcome Measures

Primary Outcomes (1)

  • Taste alteration

    taste changes will be measured by a questionnaire

    One week

Secondary Outcomes (1)

  • Salivary pH

    one week

Study Arms (4)

Propolis extract

EXPERIMENTAL

intervention

Other: Propolis extract

Pomegranate extract

EXPERIMENTAL

intervention

Other: pomegranate extract

Chlorhexidine

ACTIVE COMPARATOR

comparator

Other: chlorhexidine

Saline

PLACEBO COMPARATOR

comparator

Other: saline

Interventions

chlorhexidineOTHER

antibacterial and anti-inflammatory mouthwash

Also known as: hexitol
Chlorhexidine
salineOTHER

anti-inflammatory cleansing mouthwash

Also known as: NaCl solution
Saline
Propolis extractOTHER

antibacterial mouthwash

Propolis extract
pomegranate extractOTHER

antibacterial mouthwash

Pomegranate extract

Eligibility Criteria

Age17 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • High caries risk patients defined according to American Dental Association (ADA)
  • Systematically healthy
  • Not taking any medication interfering with saliva secretion
  • Subjects who signed informed consent
  • Age range from 17-50 years

You may not qualify if:

  • Subjects suffering from any medical or systematic disease
  • Smokers
  • Pregnant females
  • Allergy to any of the mouthwash ingredients
  • Patients older than 50 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Interventions

ChlorhexidinehexitolSodium ChlorideSaline SolutionPropolispomegranate fruit rind

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsResins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex Mixtures

Study Design

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

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 9, 2018

Study Start

March 1, 2019

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

September 11, 2018

Record last verified: 2018-09