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

Not Applicable

• Conditions: Prevention of Dental Caries
• Interventions: Other: Fluoride toothpaste; Other: fluoride toothpaste and chlorhexidine mouthwash; Other: fluoride toothpaste, chlorhexidine mouthwash, MI varnish

• Registration Number: NCT04032184
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-24
• Last Update Submitted: 2019-07-24
• Study First Posted: 2019-07-25
• Last Update Posted: 2019-07-25
• Study Start: 2019-10-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoride toothpaste	Fluoride toothpaste	-
fluoride toothpaste and chlorhexidine mouthwash	fluoride toothpaste and chlorhexidine mouthwash	-
fluoride toothpaste, chlorhexidine mouthwash, MI varnish	fluoride toothpaste, chlorhexidine mouthwash, MI varnish	-

Primary Outcome Measures

Name	Time	Method
Caries Risk Assessment	an average 3 months	will be evaluated by cariogram

Secondary Outcome Measures

Name	Time	Method
DMF scores	an average of 12 months	will be evaluated by ICDAS

Trial Locations

Locations (1)

Howaida Fakhry Fouad; 🇪🇬 Giza, Other, Egypt