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Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars

Primary Purpose

Dental Caries in Children

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Atraumatic Restorative Treatment (ART)
Smart Burs
Chemo-Mechanical Caries Removal (CMCR)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries in Children

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Caries in second primary molars within enamel/ dentin without pulp disease.
  • There is a clear band of dentin coronal.
  • Cooperative and healthy children.

Exclusion Criteria:

  • Presence of signs and symptoms of necrosis.
  • Root caries.
  • History of spontaneous pain.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Atraumatic Restorative Treatment (ART)

    Smart Burs

    Chemo-Mechanical Caries Removal (CMCR)

    Arm Description

    Atraumatic Restorative Treatment is a simple technique based on preservation of sound tooth structure and minimal patient's discomfort.

    Smart Burs are minimally invasive technique which selectively removes the infected carious dentin leaving the affected intact dentin.

    A chemical agent which selectively removes the carious dentin by breaking the denatured collagen fibers making them soft and preserving the healthy dentin without drilling.

    Outcomes

    Primary Outcome Measures

    Pain assessment
    The pain will be assessed by Visual Analogue Scale (VAS)

    Secondary Outcome Measures

    Time taken for caries removal
    The time is measured by a stopwatch in minutes
    Efficacy of caries removal
    The efficacy of caries removal will be assessed by Caries Detector dye.

    Full Information

    First Posted
    September 2, 2022
    Last Updated
    September 6, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05529433
    Brief Title
    Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars
    Official Title
    Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    November 2022 (Anticipated)
    Study Completion Date
    February 2023 (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
    No

    5. Study Description

    Brief Summary
    The aim of the clinical trial is to assess pain during Atraumatic Restorative Treatment (ART), Smart Burs and Chemo-mechanical Caries Removal (CMCR) in primary molars.
    Detailed Description
    The principles of the caries removal have changed greatly in the last decade. The use of local anesthesia with conventional techniques"high-speed hand piece" increase the fear and anxiety of the child. Minimally invasive techniques reduce the pain and anxiety of the child by eliminating the use of local anesthesia. In ART, soft carious tissue is removed by hand instruments. Although this technique is very simple. Moreover, Smart Burs are more efficient in removal of soft infected dentine than ART leaving the affected dentin intact; as when they touch hard dentin, they become dull. Finally, the recent effective method of caries removal is CMCR. The chemical agent contains proteolytic enzyme which destructs partially degraded collagen, leaving the infected dentin soft and easy to be excavated. Therefore, the aim of this study is to assess pain during Atraumatic Restorative treatment, Smart Burs and Chemo-Mechanical Caries Removal in primary molars.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries in Children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    33 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Atraumatic Restorative Treatment (ART)
    Arm Type
    Active Comparator
    Arm Description
    Atraumatic Restorative Treatment is a simple technique based on preservation of sound tooth structure and minimal patient's discomfort.
    Arm Title
    Smart Burs
    Arm Type
    Experimental
    Arm Description
    Smart Burs are minimally invasive technique which selectively removes the infected carious dentin leaving the affected intact dentin.
    Arm Title
    Chemo-Mechanical Caries Removal (CMCR)
    Arm Type
    Experimental
    Arm Description
    A chemical agent which selectively removes the carious dentin by breaking the denatured collagen fibers making them soft and preserving the healthy dentin without drilling.
    Intervention Type
    Procedure
    Intervention Name(s)
    Atraumatic Restorative Treatment (ART)
    Intervention Description
    Atraumatic Restorative Treatment is highly accepted by the patients as there is no need for local anesthesia. It is a minimal invasive technique which preserves sound tooth structure as caries removal will be done by a sharp spoon excavator. It requires less time during caries removal. There is a chemical bond between the tooth and the glass ionomer adhesive material. So, there is no need for cutting sound tooth structure for retention of the restoration.
    Intervention Type
    Procedure
    Intervention Name(s)
    Smart Burs
    Intervention Description
    Smart Bur is a polymer bur which removes only soft infected dentin as the cutting edges become dull in contact with the hard affected dentin.Caries removal will be done by Smart Bur mounted on a low speed hand-piece leaving the affected dentin intact. It requires less time for caries removal.
    Intervention Type
    Procedure
    Intervention Name(s)
    Chemo-Mechanical Caries Removal (CMCR)
    Other Intervention Name(s)
    Selecti-Solve gel (Denta Pharma, Egypt)
    Intervention Description
    Selecti-Solve gel is a dental gel which main active ingredient is Papain enzyme which selectively removes the caries without pain and has bacteriostatic, bactericidal and anti-inflammatory properties. The use of CMCR is recommended as an alternative treatment technique in anxious patients. The gel will be applied with a blunt spoon instrument and distributed well into the cavity according to manufacturer's instructions.
    Primary Outcome Measure Information:
    Title
    Pain assessment
    Description
    The pain will be assessed by Visual Analogue Scale (VAS)
    Time Frame
    at baseline
    Secondary Outcome Measure Information:
    Title
    Time taken for caries removal
    Description
    The time is measured by a stopwatch in minutes
    Time Frame
    at baseline
    Title
    Efficacy of caries removal
    Description
    The efficacy of caries removal will be assessed by Caries Detector dye.
    Time Frame
    at baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Caries in second primary molars within enamel/ dentin without pulp disease. There is a clear band of dentin coronal. Cooperative and healthy children. Exclusion Criteria: Presence of signs and symptoms of necrosis. Root caries. History of spontaneous pain.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reham Mahmoud, BDS
    Phone
    +201117892999
    Email
    reham_mahmoud@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rania Nasr, Professor
    Phone
    +201005037367
    Email
    rania.nasr@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rania Nasr, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Rasha Hatem, Associate Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Reham Mahmoud, BDS
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars

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