- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04032184
Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial
July 24, 2019 updated by: Howaida Fakhry Fouad, Cairo University
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
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Esraa A Ahmed, Phd
- Phone Number: 00201020614170
- Email: ososdent@hotmail.com
Study Contact Backup
- Name: howaida f fouad, Phd
- Phone Number: 00201010008948
- Email: howaidafakhry@gmail.com
Study Locations
-
-
Other
-
Giza, Other, Egypt, 8655
- Howaida Fakhry Fouad
-
Contact:
- Esraa A Ahmed, Phd
- Phone Number: 00201020614170
- Email: ososdent@hotmail.com
-
Contact:
- howaida f fouad, Phd
- Phone Number: 00201010008948
- Email: howaidafakhry@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fluoride toothpaste
|
regimen using fluoride toothpaste
|
Experimental: fluoride toothpaste and chlorhexidine mouthwash
|
regimen using fluoride toothpaste and chlorhexidine mouthwash
|
Experimental: fluoride toothpaste, chlorhexidine mouthwash, MI varnish
|
regimen using fluoride toothpaste, chlorhexidine mouthwash, MI varnish
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caries Risk Assessment
Time Frame: an average 3 months
|
will be evaluated by cariogram
|
an average 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DMF scores
Time Frame: an average of 12 months
|
will be evaluated by ICDAS
|
an average of 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2019
Primary Completion (Anticipated)
October 1, 2020
Study Completion (Anticipated)
November 1, 2020
Study Registration Dates
First Submitted
July 23, 2019
First Submitted That Met QC Criteria
July 24, 2019
First Posted (Actual)
July 25, 2019
Study Record Updates
Last Update Posted (Actual)
July 25, 2019
Last Update Submitted That Met QC Criteria
July 24, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1234567
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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