NCT03222960

Brief Summary

This study will be conducted to evaluate the effect of Propolis-containing toothpaste in comparison to Fluoride-containing Toothpaste by caries risk assessment 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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

July 18, 2017

Last Update Submit

July 24, 2017

Conditions

Risk Reduction

Outcome Measures

Primary Outcomes (1)

  • Improving caries risk

    caries risk assessment

    6 months

Study Arms (2)

Propolis-containing toothpaste

EXPERIMENTAL

Assessment of caries risk for participants using Propolis-containing toothpaste before the treatment , after 3 months and 6 months follow up.

Drug: propolis-containing toothpaste

Fluoride-containing toothpaste

EXPERIMENTAL

Assessment of caries risk for participants using Fluoride-containing toothpaste before the treatment , after 3 months and 6 months follow up.

Drug: Fluoride-containing toothpaste

Interventions

propolis-containing toothpasteDRUG

participants will use propolis-containing toothpaste for 6 months

Also known as: Red seal propolis toothpaste
Propolis-containing toothpaste
Fluoride-containing toothpasteDRUG

participants will use Fluoride-containing toothpaste for 6 months

Also known as: colgate
Fluoride-containing toothpaste

Eligibility Criteria

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

You may qualify if:

  • Participants should be over 18 years of age.
  • Participants should be high caries risk.
  • Systematically healthy.
  • Not taking any medication interfering with saliva secretion.
  • Participants who signed informed consent.

You may not qualify if:

  • Participants with a compromised medical history.
  • Participants under systemic disease treatment, with antibiotic, steroid or any medication known to cause dry mouth.
  • Severe or active periodontal disease.
  • History of allergies or other adverse reactions to propolis, or oral care product or their ingredient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Risk Reduction Behavior

Interventions

Sodium Fluoride

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsSodium CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

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

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 19, 2017

Study Start

October 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

July 25, 2017

Record last verified: 2017-07