Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial

Cairo University (CU)

Status: Unknown

Conditions: Prevention of Dental Caries

Treatments: Other: fluoride toothpaste and chlorhexidine mouthwash; Other: fluoride toothpaste, chlorhexidine mouthwash, MI varnish; Other: Fluoride toothpaste

Study type: Interventional

Funder types: Other

Identifiers

NCT04032184

1234567

Details and patient eligibility

About

66 Participants will be divided into three groups according to the tested regimen (A), where (A1) represents participants exposed to fluoride toothpaste, (A2) represents participants exposed to regimen including fluoride toothpaste and chlorhexidine mouthwash and (A3) represents participants exposed to regimen including fluoride toothpaste, chlorhexidine mouthwash and MI fluoride varnish. The study will be carried over a period of one year, assessment of cariogram will be done in two visits: first visit (baseline: T0) and second visit (after 3 months: T2). In addition assessment of DMF scores will be done in four visits: first visit (baseline: T0), second visit (after 3 months: T1), third visit (after 6 months: T2) and final visit (after 12 months: T3) to obtain the required data

Enrollment: 66 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age range 20-50 years
• High caries risk patients defined according to cariogram caries risk assessment model
• On non-cariogenic diet
• High plaque index
• Systematically healthy
• No orthodontic or prosthodontic appliance

Exclusion criteria

• Age range less than 20 or more than 50 years
• Low or moderate caries risk patients according to cariogram
• Patients with a compromised medical history
• Cariogenic diet patient
• 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: Double Blind

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66 participants in 3 patient groups

Fluoride toothpaste

Active Comparator group

Treatment:

Other: Fluoride toothpaste

fluoride toothpaste and chlorhexidine mouthwash

Experimental group

Treatment:

Other: fluoride toothpaste and chlorhexidine mouthwash

fluoride toothpaste, chlorhexidine mouthwash, MI varnish

Experimental group

Treatment:

Other: fluoride toothpaste, chlorhexidine mouthwash, MI varnish