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the NMFACT Caries Index

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NMFACT
DMF index
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dental Caries

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 16, 2018
    Last Updated
    March 30, 2020
    Sponsor
    Cairo University
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    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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