NCT04436913

Brief Summary

This study will be conducted in order to determine the prevention effect of caries preventive regimen using herbal toothpaste and regimen using fluoride toothpaste versus fluoride toothpaste and fluoride varnish on the caries risk of patients with high caries risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

June 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

January 16, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

June 15, 2020

Last Update Submit

July 29, 2022

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Caries risk assessment

    Change in caries risk assessment by "cariogram software" as each patient data is collected in order to be inserted into the "Cariogram software" which in turn will evaluate this data and lead to a pie chart showing the chance of avoiding new caries as percentage. This data includes caries experience, related diseases, diet content, fluoride program, salivary buffer capacity, saliva secretion rate, diet frequency, "Mutans streptococci" count, amount of plaque, and clinical examination.

    Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.

Study Arms (3)

preventive regimen using Herbal toothpaste(Himalaya)

EXPERIMENTAL

The regimen includes herbal toothpaste containing "Neem , Miswak , Babool and Pomegranate" (Himalaya Complete Care).

Other: Himalaya complete care toothpaste

preventive regimen using Fluoride based toothpaste (Signal).

EXPERIMENTAL

Participants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride)

Other: Signal toothpaste

Fluoride toothpaste and fluoride varnish

ACTIVE COMPARATOR

Participants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride) and fluoride varnish

Other: Signal toothpaste and fluoride varnish

Interventions

Himalaya complete care toothpasteOTHER

Herbal toothpaste as a part of a caries preventive regimen

preventive regimen using Herbal toothpaste(Himalaya)
Signal toothpasteOTHER

fluoride based toothpaste as a part of a caries preventive regimen

preventive regimen using Fluoride based toothpaste (Signal).
Signal toothpaste and fluoride varnishOTHER

application of fluoride varnish and using fluoride based toothpaste

Fluoride toothpaste and fluoride varnish

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy patients with free medical history.
  • Age range 15-50 years.
  • Patients with high caries risk assessment due to increased cariogenic bacteria according to Cariogram.
  • low fermentable carbohydrates diet patient
  • Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study.

You may not qualify if:

  • Patients with a compromised medical history.
  • Cariogenic diet patient.
  • Extreme plaque accumulation and periodontal problems
  • Participants with a history of allergy to any of the drugs or chemicals used in the study.
  • Patients on any antibiotics during the past month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university, Faculty of oral and dental medicine

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator , Master degree student, Conservative Dentistry Department, Faculty of Dentistry, Cairo University

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 18, 2020

Study Start

January 16, 2021

Primary Completion

September 20, 2021

Study Completion

January 31, 2022

Last Updated

August 1, 2022

Record last verified: 2022-07

Locations

EG(1)