the NMFACT Caries Index
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NMFACT
DMF index
Sponsored by
About this trial
This is an interventional diagnostic trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- any patient suffering form dental problem
Exclusion Criteria:
- edentulous patient children adolescents
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NMFACT
DMF index
Arm Description
record the caries index using the NMFACT chart
record the caries index using the DMF chart
Outcomes
Primary Outcome Measures
the accuracy of NMFACT index in describe the oral health condition
finding from the group will be compared to clinical examination by different accessors .the accurate detailed description of the oral health condition will assessed statistically
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04330794
Brief Title
the NMFACT Caries Index
Official Title
the NMFACT Anew Caries Index
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2021 (Anticipated)
Primary Completion Date
January 15, 2022 (Anticipated)
Study Completion Date
January 15, 2022 (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
the NMFACT is a new caries index to overcome the drawbacks of DMF cries index the ''N'' is for non carious lesion, the ''M''for missed teeth,the ''F''for filled teeth,the''C''for carious teeth,the ''A''for alignment and the ''T''for dental trauma.
each problem will be scored from 0(normal).
Detailed Description
the new caries index will be used to record the dental problem . the validation will be recorded against the gold standard DMF index
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NMFACT
Arm Type
Experimental
Arm Description
record the caries index using the NMFACT chart
Arm Title
DMF index
Arm Type
Active Comparator
Arm Description
record the caries index using the DMF chart
Intervention Type
Other
Intervention Name(s)
NMFACT
Other Intervention Name(s)
NMFACT chart
Intervention Description
caries index
Intervention Type
Other
Intervention Name(s)
DMF index
Other Intervention Name(s)
DMF chart
Intervention Description
caries index chart to collect data about decayed missed filled teeth
Primary Outcome Measure Information:
Title
the accuracy of NMFACT index in describe the oral health condition
Description
finding from the group will be compared to clinical examination by different accessors .the accurate detailed description of the oral health condition will assessed statistically
Time Frame
3months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
any patient suffering form dental problem
Exclusion Criteria:
edentulous patient children adolescents
12. IPD Sharing Statement
Plan to Share IPD
No
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the NMFACT Caries Index
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