NCT04446390

Brief Summary

This study will be conducted to assess the effect of different preventive regimens using herbal toothpaste versus fluoride toothpaste on the management of remineralization and caries risk in high caries risk patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

2 active sites

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

June 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 3, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

June 22, 2020

Last Update Submit

January 20, 2022

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Remineralization of initial carious lesions

    changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20): healthy teeth (0-14), initial carious lesions (14-20), dentinal caries (more than 20)

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

Secondary Outcomes (1)

  • Caries risk assessment

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

Study Arms (2)

preventive regimen using Herbal toothpaste(Himalaya)

EXPERIMENTAL

The regimen includes herbal toothpaste containing "Neem , Miswak , Babool and Pomegranate" (Himalaya Complete Care). Chew xylitol gum 2 pieces four times per day for 5 minutes after meals.

Other: Himalaya complete care toothpaste

preventive regimen using Fluoride based toothpaste(colgate)

ACTIVE COMPARATOR

preventive regimen using Fluoride based toothpaste (colgate cavity protection). Participants will be using a fluoride-based toothpaste (colgate cavity protection), (1450 ppm Sodium monofluorophosphate). chew xylitol gum 2 pieces four times per day for 5 minutes after meals.

Other: colgate cavity protection

Interventions

Himalaya complete care toothpasteOTHER

Herbal toothpaste as a part of a caries preventive regimen

preventive regimen using Herbal toothpaste(Himalaya)
colgate cavity protectionOTHER

fluoride toothpaste as a part of a caries preventive regimen

preventive regimen using Fluoride based toothpaste(colgate)

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 according to Cariogram.
  • Patients with initial carious lesions at the facial surface of any teeth
  • High plaque index
  • 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.
  • Patients with dentin caries
  • Extreme plaque accumulation and periodontal problems
  • Completely edentulous patients
  • 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
  • The WSLs with LF measurements inside the range 14-20 were involved in this study.
  • The lesions with scoring either 2 or 3 according to (ICDAS) scoring were included in the study
  • The white spot lesion scoring is (\<14) or (\>20) according to diagnodent
  • The white spot lesion scoring is other than 2, 3 according to ICDAS
  • White spot lesions due to hypomineralization or fluorosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University, Faculty of Oral and Dental Medicine

Cairo, Egypt

Location

Cairo University

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
Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 24, 2020

Study Start

January 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

February 3, 2022

Record last verified: 2022-01

Locations

EG(2)