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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Other: Himalaya complete care toothpaste; Other: Signal toothpaste; Other: Signal toothpaste and fluoride varnish

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo university, Faculty of oral and dental medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: preventive regimen using Herbal toothpaste(Himalaya); The regimen includes herbal toothpaste containing "Neem , Miswak , Babool and Pomegranate" (Himalaya Complete Care).	Other: Himalaya complete care toothpaste; Herbal toothpaste as a part of a caries preventive regimen
EXPERIMENTAL: preventive regimen using Fluoride based toothpaste (Signal).; Participants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride)	Other: Signal toothpaste; fluoride based toothpaste as a part of a caries preventive regimen
ACTIVE_COMPARATOR: Fluoride toothpaste and fluoride varnish; Participants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride) and fluoride varnish	Other: Signal toothpaste and fluoride varnish; application of fluoride varnish and using fluoride based toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2021
• Primary Completion (ACTUAL): September 20, 2021
• Study Completion (ACTUAL): January 31, 2022

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (ACTUAL): June 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: Himalaya complete care

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No