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

Prevention of Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04032184
• Other study ID #: 1234567
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: howaida f fouad, Phd
• Phone: 00201010008948
• Email: howaidafakhry[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: November 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Prevention of Dental Caries

Intervention

Other:
• Fluoride toothpaste
regimen using fluoride toothpaste
• fluoride toothpaste and chlorhexidine mouthwash
regimen using fluoride toothpaste and chlorhexidine mouthwash
• fluoride toothpaste, chlorhexidine mouthwash, MI varnish
regimen using fluoride toothpaste, chlorhexidine mouthwash, MI varnish

Locations

Country	Name	City	State
Egypt	Howaida Fakhry Fouad	Giza	Other

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries Risk Assessment	will be evaluated by cariogram	an average 3 months
Secondary	DMF scores	will be evaluated by ICDAS	an average of 12 months