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Evaluation of Preventive Regimens With Different Toothpastes vs Fluoride Varnish & Toothpaste in High Caries Patients

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Himalaya complete care toothpaste
Signal toothpaste
Signal toothpaste and fluoride varnish
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Cairo university, Faculty of oral and dental medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

preventive regimen using Herbal toothpaste(Himalaya)

preventive regimen using Fluoride based toothpaste (Signal).

Fluoride toothpaste and fluoride varnish

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2020
Last Updated
July 29, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04436913
Brief Title
Evaluation of Preventive Regimens With Different Toothpastes vs Fluoride Varnish & Toothpaste in High Caries Patients
Official Title
Evaluation of Prevention Potential of Preventive Regimens Containing Herbal-based and Fluoride-based Toothpastes Versus Fluoride Varnish and Fluoride Toothpaste Only in High Caries Risk Patients: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 16, 2021 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Dental caries is highly predominant worldwide. So, in addition to treating this caries, patients should be managed to avoid new caries. Preventive measures could be applied to the patients who are most expected to develop dental caries who are identified by caries risk assessment. Thus, effective caries risk assessment is essential to control new caries development. Dental caries can be prevented by conducting appropriate measures; therefore, it is crucial to identify those who are most likely to have dental caries by caries risk assessment and giving them the essential preventive measures. Though some caries preventive measures have showed success in descriptive clinical trials, there is little information on their practicality with high caries risk groups in everyday usage. Oral health is an essential part of general well being, people have used herbs in order to prevent dental diseases for centuries. In 2008 the Federal Council of Dentistry approved the use of medicinal plants for oral healthcare. Medicinal plants can heal bacterial diseases as it is full of antimicrobial agents. They are becoming more popular than chemicals due to the side effects of synthetic antibiotics and the antibiotic resistance in microorganisms. Studies propose that herbal extracts are highly effective against significant microorganism which cause dental caries like Streptococcus mutans. Herbal toothpaste decreases dental caries through combined effects of antibacterial agents, oral acid neutralisers and decreased plaque bacterial enzyme inhibitors present in the herbal toothpaste.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
preventive regimen using Herbal toothpaste(Himalaya)
Arm Type
Experimental
Arm Description
The regimen includes herbal toothpaste containing "Neem , Miswak , Babool and Pomegranate" (Himalaya Complete Care).
Arm Title
preventive regimen using Fluoride based toothpaste (Signal).
Arm Type
Experimental
Arm Description
Participants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride)
Arm Title
Fluoride toothpaste and fluoride varnish
Arm Type
Active Comparator
Arm Description
Participants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride) and fluoride varnish
Intervention Type
Other
Intervention Name(s)
Himalaya complete care toothpaste
Intervention Description
Herbal toothpaste as a part of a caries preventive regimen
Intervention Type
Other
Intervention Name(s)
Signal toothpaste
Intervention Description
fluoride based toothpaste as a part of a caries preventive regimen
Intervention Type
Other
Intervention Name(s)
Signal toothpaste and fluoride varnish
Intervention Description
application of fluoride varnish and using fluoride based toothpaste
Primary Outcome Measure Information:
Title
Caries risk assessment
Description
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.
Time Frame
Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Cairo university, Faculty of oral and dental medicine
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Evaluation of Preventive Regimens With Different Toothpastes vs Fluoride Varnish & Toothpaste in High Caries Patients

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