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

Cairo University (CU)

Status: Completed

Conditions: Dental Caries

Treatments: Other: Himalaya complete care toothpaste; Other: Signal toothpaste; Other: Signal toothpaste and fluoride varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT04436913

Himalaya complete care

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 15 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 3 patient groups

preventive regimen using Herbal toothpaste(Himalaya)

Experimental group

Description:

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

Treatment:

Other: Himalaya complete care toothpaste

preventive regimen using Fluoride based toothpaste (Signal).

Experimental group

Description:

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

Treatment:

Other: Signal toothpaste

Fluoride toothpaste and fluoride varnish

Active Comparator group

Description:

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

Treatment:

Other: Signal toothpaste and fluoride varnish