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Postoperative Hypersensitivity and Digital Radiographic Assessment of a Zinc Modified Versus a Conventional Glass Ionomer Cement in Deep Carious Lesion: Randomized Controlled Clinical Trial

Primary Purpose

Carious Dentin

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Partial caries removel techniques
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carious Dentin focused on measuring Incomplete caries removel, Partial caries removel

Eligibility Criteria

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

Inclusion Criteria:

  1. Male or female (>18 y)
  2. patient with At least 1 deep carious lesion
  3. Clinical symptoms of reversible pulpitis with positive pulp response

Exclusion Criteria:

  • 1. Patient suffer from irreversible pulpitis (pain with hot or instant pain lasting for a while, resistant to analgesic) 2. Presence of any sign of periapical lesion (like sinus tract ) 3. Teeth with periodontal problem 4. Anterior teeth (material used for non aesthetic region) 5. Pregnant women, to avoid multiple exposure to x ray 6. Patients unable to give consent(mentally retarted, or refuse to right a consent)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Zinc modified glass ionomer

    Conventionel glass ionomer

    Arm Description

    Zinc modified glass ionomer (chemfill rock) galss ionomer used as restoration for posterior teeth in case of partial caries removel

    Conventional glass ionomer used as restoration for posterior teeth in case of partial caries removel

    Outcomes

    Primary Outcome Measures

    Digital radigraphic assessment
    The presence of periapical change or change in lamina dura change after the procedure

    Secondary Outcome Measures

    Post opreative hypersenstivity
    The presence or absence of pain with thermal

    Full Information

    First Posted
    September 14, 2017
    Last Updated
    September 14, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03285022
    Brief Title
    Postoperative Hypersensitivity and Digital Radiographic Assessment of a Zinc Modified Versus a Conventional Glass Ionomer Cement in Deep Carious Lesion: Randomized Controlled Clinical Trial
    Official Title
    Postoperative Hypersensitivity and Digital Radiographic Assessment of a Zinc Modified Versus a Conventional Glass Ionomer Cement in Deep Carious Lesion: Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 20, 2017 (Anticipated)
    Primary Completion Date
    April 20, 2018 (Anticipated)
    Study Completion Date
    April 20, 2018 (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 study aim to evaluate the difference between the effect of zinc modified glass ionomer and conventional glass ionomer on the success of partial caries removel technique
    Detailed Description
    The zinc ion has an antibacterial effect which could increase the success of partial caries removel technique by decreasing the bactrial population .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carious Dentin
    Keywords
    Incomplete caries removel, Partial caries removel

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Outcome assessor and participant will be blinded to the type of material
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Zinc modified glass ionomer
    Arm Type
    Experimental
    Arm Description
    Zinc modified glass ionomer (chemfill rock) galss ionomer used as restoration for posterior teeth in case of partial caries removel
    Arm Title
    Conventionel glass ionomer
    Arm Type
    Active Comparator
    Arm Description
    Conventional glass ionomer used as restoration for posterior teeth in case of partial caries removel
    Intervention Type
    Procedure
    Intervention Name(s)
    Partial caries removel techniques
    Other Intervention Name(s)
    Partial caries removel
    Intervention Description
    Removel of all superfacial dentin and leaving the inner affectted dentin
    Primary Outcome Measure Information:
    Title
    Digital radigraphic assessment
    Description
    The presence of periapical change or change in lamina dura change after the procedure
    Time Frame
    At baseline ,3months and 6 months
    Secondary Outcome Measure Information:
    Title
    Post opreative hypersenstivity
    Description
    The presence or absence of pain with thermal
    Time Frame
    Baseline ,at 3 months and at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male or female (>18 y) patient with At least 1 deep carious lesion Clinical symptoms of reversible pulpitis with positive pulp response Exclusion Criteria: 1. Patient suffer from irreversible pulpitis (pain with hot or instant pain lasting for a while, resistant to analgesic) 2. Presence of any sign of periapical lesion (like sinus tract ) 3. Teeth with periodontal problem 4. Anterior teeth (material used for non aesthetic region) 5. Pregnant women, to avoid multiple exposure to x ray 6. Patients unable to give consent(mentally retarted, or refuse to right a consent)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dina Mounir Elkady, Assitant lecturer
    Phone
    01004297317
    Email
    Dina.elkady@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Riad Farid, Professor
    Phone
    01223113166
    Email
    mriad_52@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Postoperative Hypersensitivity and Digital Radiographic Assessment of a Zinc Modified Versus a Conventional Glass Ionomer Cement in Deep Carious Lesion: Randomized Controlled Clinical Trial

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