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Post-operative Pain and Child Behavior of Hall Technique Versus SDF in the Management of Carious Primary Molars: RCT

Primary Purpose

Caries

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Silver diamine fluoride
Hall Technique
Sponsored by
Noura Mohamed Alhosaini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age: From 4 to 6 years
  2. Clinical diagnosis of tooth with caries in primary molars within enamel or dentin without pulp disease

Exclusion Criteria:

  1. Tooth with signs and symptoms of pulp necrosis
  2. Tooth with Root caries
  3. Tooth with Spontaneous pain

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    control group

    experimental group

    Arm Description

    The group that have caries in primary molars and treat them with Hall Technique

    The group that have caries in primary molars and treat them with Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC.

    Outcomes

    Primary Outcome Measures

    post-operative pain
    Face Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.
    post-operative pain
    Face Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.
    post-operative pain
    Face Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.
    post-operative pain
    Face Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.
    post-operative pain
    Face Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.

    Secondary Outcome Measures

    Child Anxiety
    Venham Anxiety rating scale is a reliable system for rating behavior of children in the dental setting. Six-point scales 0-1-2-3-4-5
    Child behavior
    Venham behavior rating scale is a reliable system for rating behavior of children in the dental setting. Six-point scales 0-1-2-3-4-5
    Intra operative pain
    Face Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.

    Full Information

    First Posted
    February 22, 2021
    Last Updated
    May 9, 2021
    Sponsor
    Noura Mohamed Alhosaini
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04794426
    Brief Title
    Post-operative Pain and Child Behavior of Hall Technique Versus SDF in the Management of Carious Primary Molars: RCT
    Official Title
    Post-operative Pain and Child Behavior of Hall Technique Versus Silver Diamine Fluoride in the Management of Carious Primary Molars: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    July 20, 2022 (Anticipated)
    Study Completion Date
    July 29, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Noura Mohamed Alhosaini

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    PICO question: Papulation: children suffering from caries Intervention: Silver Diamine Fluoride Comparison: Hall technique Outcome: Primary Outcome: Intraoperative and postoperative pain Measurement device: Face pain scale Revised8 Measurement unit: Score 0-2-4-6-8-10 Secondary Outcome: Child Anxiety Measurement device: Venham Anxiety rating scale 9 Measurement unit: Six-point scales 0-1-2-3-4-5 Child Behavior Measurement device: Venham Behavior rating scale 9 Measurement unit: Six-point scales 0-1-2-3-4-5
    Detailed Description
    Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle 1. A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride. The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method2. Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC) 3

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    The group that have caries in primary molars and treat them with Hall Technique
    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    The group that have caries in primary molars and treat them with Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC.
    Intervention Type
    Drug
    Intervention Name(s)
    Silver diamine fluoride
    Intervention Description
    Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)
    Intervention Type
    Device
    Intervention Name(s)
    Hall Technique
    Intervention Description
    The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method.
    Primary Outcome Measure Information:
    Title
    post-operative pain
    Description
    Face Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.
    Time Frame
    at 2 days
    Title
    post-operative pain
    Description
    Face Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.
    Time Frame
    at 1 week
    Title
    post-operative pain
    Description
    Face Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.
    Time Frame
    at 2 weeks
    Title
    post-operative pain
    Description
    Face Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.
    Time Frame
    at 1 month
    Title
    post-operative pain
    Description
    Face Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.
    Time Frame
    at 6 months
    Secondary Outcome Measure Information:
    Title
    Child Anxiety
    Description
    Venham Anxiety rating scale is a reliable system for rating behavior of children in the dental setting. Six-point scales 0-1-2-3-4-5
    Time Frame
    Immediately
    Title
    Child behavior
    Description
    Venham behavior rating scale is a reliable system for rating behavior of children in the dental setting. Six-point scales 0-1-2-3-4-5
    Time Frame
    Immediately
    Title
    Intra operative pain
    Description
    Face Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.
    Time Frame
    Immediately

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age: From 4 to 6 years Clinical diagnosis of tooth with caries in primary molars within enamel or dentin without pulp disease Exclusion Criteria: Tooth with signs and symptoms of pulp necrosis Tooth with Root caries Tooth with Spontaneous pain
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Noura M Alhosaini, B.D.S
    Phone
    01115877726
    Ext
    002
    Email
    noura.talat@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed m Elkhadem, Ass. Prof
    Phone
    01064440888
    Ext
    002
    Email
    Ahmed.Elkhadem@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sherif B Eltaweil, Prof
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32522320
    Citation
    Ebrahimi M, Shirazi AS, Afshari E. Success and Behavior During Atraumatic Restorative Treatment, the Hall Technique, and the Stainless Steel Crown Technique for Primary Molar Teeth. Pediatr Dent. 2020 May 15;42(3):187-192.
    Results Reference
    result
    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/32522320/
    Description
    Success and Behavior During Atraumatic Restorative Treatment, the Hall Technique, and the Stainless Steel Crown Technique for Primary Molar Teeth

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    Post-operative Pain and Child Behavior of Hall Technique Versus SDF in the Management of Carious Primary Molars: RCT

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