Back to resultsEffectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial
Primary Purpose
Prevention of Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fluoride toothpaste
fluoride toothpaste and chlorhexidine mouthwash
fluoride toothpaste, chlorhexidine mouthwash, MI varnish
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Dental Caries
Eligibility Criteria
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
Sites / Locations
- Howaida Fakhry Fouad
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Fluoride toothpaste
fluoride toothpaste and chlorhexidine mouthwash
fluoride toothpaste, chlorhexidine mouthwash, MI varnish
Arm Description
Outcomes
Primary Outcome Measures
Caries Risk Assessment
will be evaluated by cariogram
Secondary Outcome Measures
DMF scores
will be evaluated by ICDAS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04032184
Brief Title
Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial
Official Title
Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Dental Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluoride toothpaste
Arm Type
Active Comparator
Arm Title
fluoride toothpaste and chlorhexidine mouthwash
Arm Type
Experimental
Arm Title
fluoride toothpaste, chlorhexidine mouthwash, MI varnish
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Fluoride toothpaste
Intervention Description
regimen using fluoride toothpaste
Intervention Type
Other
Intervention Name(s)
fluoride toothpaste and chlorhexidine mouthwash
Intervention Description
regimen using fluoride toothpaste and chlorhexidine mouthwash
Intervention Type
Other
Intervention Name(s)
fluoride toothpaste, chlorhexidine mouthwash, MI varnish
Intervention Description
regimen using fluoride toothpaste, chlorhexidine mouthwash, MI varnish
Primary Outcome Measure Information:
Title
Caries Risk Assessment
Description
will be evaluated by cariogram
Time Frame
an average 3 months
Secondary Outcome Measure Information:
Title
DMF scores
Description
will be evaluated by ICDAS
Time Frame
an average of 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
howaida f fouad, Phd
Phone
00201010008948
Email
howaidafakhry@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Esraa A Ahmed, Phd
Phone
00201020614170
Email
ososdent@hotmail.com
Facility Information:
Facility Name
Howaida Fakhry Fouad
City
Giza
State/Province
Other
ZIP/Postal Code
8655
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
howaida f fouad, Phd
Phone
00201010008948
Email
howaidafakhry@gmail.com
First Name & Middle Initial & Last Name & Degree
Esraa A Ahmed, Phd
Phone
00201020614170
Email
ososdent@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial
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