Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial
1 other identifier
interventional
66
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
July 25, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedJuly 25, 2019
July 1, 2019
1 year
July 23, 2019
July 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Caries Risk Assessment
will be evaluated by cariogram
an average 3 months
Secondary Outcomes (1)
DMF scores
an average of 12 months
Study Arms (3)
Fluoride toothpaste
ACTIVE COMPARATORfluoride toothpaste and chlorhexidine mouthwash
EXPERIMENTALfluoride toothpaste, chlorhexidine mouthwash, MI varnish
EXPERIMENTALInterventions
regimen using fluoride toothpaste and chlorhexidine mouthwash
regimen using fluoride toothpaste, chlorhexidine mouthwash, MI varnish
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Howaida Fakhry Fouad
Giza, Other, 8655, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident of conservative departement , Faculty of Oral and Dental Medicine, Cairo university 2012
Study Record Dates
First Submitted
July 23, 2019
First Posted
July 25, 2019
Study Start
October 1, 2019
Primary Completion
October 1, 2020
Study Completion
November 1, 2020
Last Updated
July 25, 2019
Record last verified: 2019-07