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Caries Arresting in Primary Molar Teeth Using SDF VS ART

Primary Purpose

Dental Caries

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SDF
SDF + ART (SMART technique )
Sponsored by
Ola Adel Abdelfadil Ahmed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

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

Inclusion Criteria: • Age: 4-6 years old age.

  • Both genders.
  • Decayed vital primary molars (asymptomatic teeth with active single-surface lesions, vital pulp no signs of irreversible pulpitis) .

Exclusion Criteria:

  • History of systemic conditions.
  • Allergy to silver.
  • Oral ulceration.
  • Teeth with proximal or multi-surfaces caries, pulp pathology.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SDF

    SDF + ART ( SMART technique )

    Arm Description

    Outcomes

    Primary Outcome Measures

    ECOHIS
    Early Childhood Oral Health Impact Scale.

    Secondary Outcome Measures

    - Clinical effectiveness Caries arrestment/ treatment
    International Caries Detection and Assessment System (ICDAS II)

    Full Information

    First Posted
    December 27, 2021
    Last Updated
    December 27, 2021
    Sponsor
    Ola Adel Abdelfadil Ahmed
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05188846
    Brief Title
    Caries Arresting in Primary Molar Teeth Using SDF VS ART
    Official Title
    Caries Arresting Treatment Using Silver Diamine Fluoride (SDF) Versus SDF Modified Atraumatic Restorative Technique (SMART) for Management of Carious Vital Primary Teeth: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 25, 2022 (Anticipated)
    Primary Completion Date
    January 2023 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ola Adel Abdelfadil Ahmed

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study aimed to evaluate the oral health related quality of life ( OHRQoL), during caries management in children with vital carious primary teeth with no signs of irreversible pulpitis using SDF alone or SDF in combination with ART, using Early Childhood Oral Health Impact Scale (ECOHIS).
    Detailed Description
    Early childhood caries (ECC) is a type of dental caries in the teeth of infants and children that is represented as one of the most prevalent dental problems in this period, which can lead to pain, infection, interference with eating. According to the ADA, (ECC) is described as "the presence of one or more decayed ( cavitated or non cavitated lesions), missing (due to caries), or filled tooth surfaces in any primary tooth" in children. Overall, 50% of children have one or more decayed primary teeth by the end of toddler age, but the importance of these teeth should not be neglected, because, healthy teeth in childhood have an important role in the eruption of healthy permanent teeth, healthy nutrition, and aesthetic appearance. Conventional treatment methods (drill and fill) involve the use of rotary burs under local anesthesia which develops pain and needs cooperative child and highly trained dental health personnel and consider an invasive technique, on the other hand (ART) is an approach to increase accessibility to restorative treatment, inexpensive and can be employed in regions without electricity and running water. In addition, ART is a minimally invasive treatment that requires no rotary instruments or local anesthesia to remove decayed tissue before sealing the cavity with high viscosity glass ionomer cement (GIC). (SDF), a low-cost cariostatic agent and a noninvasive method for caries management, treatment with SDF are easy, effective, and well accepted, it is also an alternative to traditional restorative treatment and may influence the reduction of untreated carious lesions in childhood

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

    8. Arms, Groups, and Interventions

    Arm Title
    SDF
    Arm Type
    Experimental
    Arm Title
    SDF + ART ( SMART technique )
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    SDF
    Intervention Description
    1. Group 1: cleaning the occlusal surface to be treated with toothbrush. Decayed tissue from the affected teeth will not be removed for the SDF group. Clinical procedure for SDF application: it will apply according to the SDF manufacturer Instructions as follows:(1) the surrounding gingival tissues and lips will be protected with petroleum jelly to avoid staining and irritation,(2) the affected tooth will be isolated and keep dry with cotton rolls and saliva ejectors, (3) one drop of SDF (SDI RIVA STAR ), will be placed into a disposable dish, (4) SDF will be applied with a micro-sponge directly to the affected tooth surface(s), (5) allowed to soak in for 2 min, then air-dried. Then will be followed by the Potassium iodide (KI) liquid to decrease discoloration caused by SDF. The KI liquid will be reapplied until no more white perception observed to form.
    Intervention Type
    Other
    Intervention Name(s)
    SDF + ART (SMART technique )
    Intervention Description
    2. Group 2: SDF+ART clinical procedure: (1)cleaning the occlusal surface to be treated with toothbrush.,(2) carious dentin will be removed using a small excavator (Spoon excavator ),(3) the cavity will be cleaned and dried, (4)cavity walls and floor will be conditioned for 10s, then washed and dried, (5) SDF will be applied as mentioned above followed by cavity restoration using resin-reinforced glass ionomer restorative material (SDI RIVA ).
    Primary Outcome Measure Information:
    Title
    ECOHIS
    Description
    Early Childhood Oral Health Impact Scale.
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    - Clinical effectiveness Caries arrestment/ treatment
    Description
    International Caries Detection and Assessment System (ICDAS II)
    Time Frame
    6 month

    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: 4-6 years old age. Both genders. Decayed vital primary molars (asymptomatic teeth with active single-surface lesions, vital pulp no signs of irreversible pulpitis) . Exclusion Criteria: History of systemic conditions. Allergy to silver. Oral ulceration. Teeth with proximal or multi-surfaces caries, pulp pathology.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ola Adel, Master
    Phone
    01012006422
    Email
    olaadel@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Passant Nagi, PHD
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nevine Waly, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Caries Arresting in Primary Molar Teeth Using SDF VS ART

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