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

NCT ID: NCT04436913

Last Updated: 2022-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-16

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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preventive regimen using Herbal toothpaste(Himalaya)

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

Group Type EXPERIMENTAL

Himalaya complete care toothpaste

Intervention Type OTHER

Herbal toothpaste as a part of a caries preventive regimen

preventive regimen using Fluoride based toothpaste (Signal).

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

Group Type EXPERIMENTAL

Signal toothpaste

Intervention Type OTHER

fluoride based toothpaste as a part of a caries preventive regimen

Fluoride toothpaste and fluoride varnish

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

Group Type ACTIVE_COMPARATOR

Signal toothpaste and fluoride varnish

Intervention Type OTHER

application of fluoride varnish and using fluoride based toothpaste

Interventions

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Himalaya complete care toothpaste

Herbal toothpaste as a part of a caries preventive regimen

Intervention Type OTHER

Signal toothpaste

fluoride based toothpaste as a part of a caries preventive regimen

Intervention Type OTHER

Signal toothpaste and fluoride varnish

application of fluoride varnish and using fluoride based toothpaste

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hoda Abdelmeguid Mohamed Fathy Ismail Sabry

Principal Investigator , Master degree student, Conservative Dentistry Department, Faculty of Dentistry, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo university, Faculty of oral and dental medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Himalaya complete care

Identifier Type: -

Identifier Source: org_study_id

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