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Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars

Primary Purpose

Deep Carious Lesion, Indirect Pulp Treatment

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Calcium silicate liner
Calcium hydroxide liner
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Carious Lesion focused on measuring resin modified calcium silicate, indirect pulp treatment, primary molars

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Medically free children.
  2. Age range from 4-7 years.
  3. Presence of lower second primary molars with deep carious occlusal lesion.
  4. No history of spontaneous pain (reversible pulpitis).
  5. Clinically: Absence of swelling, sinus, fistula, pain on percussion and tooth mobility.
  6. Radiographically: Absence of radiolucent lesions at furcation or periapical region and absence of internal or external root resorption.

Exclusion Criteria:

  1. Uncooperative children.
  2. Any unmet previous criterion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Resin Modified Calcium Silicate

    Light Cured Calcium Hydroxide

    Arm Description

    light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping

    gold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization.

    Outcomes

    Primary Outcome Measures

    Postoperative pain
    Pain questionnaire (binary yes/no)
    Postoperative pain
    Pain questionnaire (binary yes/no)
    Postoperative pain
    Pain questionnaire (binary yes/no)
    Postoperative pain
    Pain questionnaire (binary yes/no)

    Secondary Outcome Measures

    Swelling
    Visual examination by the operator (binary yes/no)
    Swelling
    Visual examination by the operator (binary yes/no)
    Swelling
    Visual examination by the operator (binary yes/no)
    Swelling
    Visual examination by the operator (binary yes/no)
    Sinus or fistula
    Visual examination by the operator (binary yes/no)
    Sinus or fistula
    Visual examination by the operator (binary yes/no)
    Sinus or fistula
    Visual examination by the operator (binary yes/no)
    Sinus or fistula
    Visual examination by the operator (binary yes/no)
    Tooth mobility
    back of the mirror to check mobility (binary yes/no)
    Tooth mobility
    back of the mirror to check mobility (binary yes/no)
    Tooth mobility
    back of the mirror to check mobility (binary yes/no)
    Tooth mobility
    back of the mirror to check mobility (binary yes/no)
    pain on percussion
    back of the mirror to check pain on percussion (binary yes/no)
    pain on percussion
    back of the mirror to check pain on percussion (binary yes/no)
    pain on percussion
    back of the mirror to check pain on percussion (binary yes/no)
    pain on percussion
    back of the mirror to check pain on percussion (binary yes/no)
    Occurrence of radiolucent lesions at furcation or periapical region
    (binary yes/no)
    Occurrence of radiolucent lesions at furcation or periapical region
    (binary yes/no)
    Occurrence of radiolucent lesions at furcation or periapical region
    (binary yes/no)
    Occurrence of radiolucent lesions at furcation or periapical region
    (binary yes/no)
    widening in the periodontal membrane space
    (binary yes/no)
    widening in the periodontal membrane space
    (binary yes/no)
    widening in the periodontal membrane space
    (binary yes/no)
    widening in the periodontal membrane space
    (binary yes/no)
    presence of internal or external root resorption
    (binary yes/no)
    presence of internal or external root resorption
    (binary yes/no)
    presence of internal or external root resorption
    (binary yes/no)
    presence of internal or external root resorption
    (binary yes/no)

    Full Information

    First Posted
    December 27, 2018
    Last Updated
    January 12, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03791255
    Brief Title
    Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars
    Official Title
    Clinical and Radiographic Evaluation of Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2019 (Anticipated)
    Primary Completion Date
    February 2020 (Anticipated)
    Study Completion Date
    February 2021 (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 objective of this study is to explore if light cured resin modified Calcium silicate could result in better clinical and radiographic success if compared to light cured Calcium hydroxide when used in indirect pulp capping treatment in primary molars.
    Detailed Description
    To evaluate clinical and radiographic success of resin modified calcium silicate in comparison to light cured calcium hydroxide as indirect pulp capping materials in primary molars. P: Children aged (4-7 years) with deep carious lesions in lower primary second molars indicated for indirect pulp treatment. I: Indirect pulp treatment using light cured resin modified Calcium Silicate (TheraCal). C: Indirect pulp treatment using light cured Calcium Hydroxide. O: clinical and radiographic success.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deep Carious Lesion, Indirect Pulp Treatment
    Keywords
    resin modified calcium silicate, indirect pulp treatment, primary molars

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Resin Modified Calcium Silicate
    Arm Type
    Experimental
    Arm Description
    light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping
    Arm Title
    Light Cured Calcium Hydroxide
    Arm Type
    Active Comparator
    Arm Description
    gold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization.
    Intervention Type
    Drug
    Intervention Name(s)
    Calcium silicate liner
    Intervention Description
    new light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping
    Intervention Type
    Drug
    Intervention Name(s)
    Calcium hydroxide liner
    Intervention Description
    Calcium hydroxide is the gold standard for pulp capping, allows for the formation of a reparative dentin bridge
    Primary Outcome Measure Information:
    Title
    Postoperative pain
    Description
    Pain questionnaire (binary yes/no)
    Time Frame
    1 month
    Title
    Postoperative pain
    Description
    Pain questionnaire (binary yes/no)
    Time Frame
    3 months
    Title
    Postoperative pain
    Description
    Pain questionnaire (binary yes/no)
    Time Frame
    6 months
    Title
    Postoperative pain
    Description
    Pain questionnaire (binary yes/no)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Swelling
    Description
    Visual examination by the operator (binary yes/no)
    Time Frame
    1 month
    Title
    Swelling
    Description
    Visual examination by the operator (binary yes/no)
    Time Frame
    3 months
    Title
    Swelling
    Description
    Visual examination by the operator (binary yes/no)
    Time Frame
    6 months
    Title
    Swelling
    Description
    Visual examination by the operator (binary yes/no)
    Time Frame
    12 months
    Title
    Sinus or fistula
    Description
    Visual examination by the operator (binary yes/no)
    Time Frame
    1 month
    Title
    Sinus or fistula
    Description
    Visual examination by the operator (binary yes/no)
    Time Frame
    3 months
    Title
    Sinus or fistula
    Description
    Visual examination by the operator (binary yes/no)
    Time Frame
    6 months
    Title
    Sinus or fistula
    Description
    Visual examination by the operator (binary yes/no)
    Time Frame
    12 months
    Title
    Tooth mobility
    Description
    back of the mirror to check mobility (binary yes/no)
    Time Frame
    1 month
    Title
    Tooth mobility
    Description
    back of the mirror to check mobility (binary yes/no)
    Time Frame
    3 months
    Title
    Tooth mobility
    Description
    back of the mirror to check mobility (binary yes/no)
    Time Frame
    6 months
    Title
    Tooth mobility
    Description
    back of the mirror to check mobility (binary yes/no)
    Time Frame
    12 months
    Title
    pain on percussion
    Description
    back of the mirror to check pain on percussion (binary yes/no)
    Time Frame
    1 month
    Title
    pain on percussion
    Description
    back of the mirror to check pain on percussion (binary yes/no)
    Time Frame
    3 months
    Title
    pain on percussion
    Description
    back of the mirror to check pain on percussion (binary yes/no)
    Time Frame
    6 months
    Title
    pain on percussion
    Description
    back of the mirror to check pain on percussion (binary yes/no)
    Time Frame
    12 months
    Title
    Occurrence of radiolucent lesions at furcation or periapical region
    Description
    (binary yes/no)
    Time Frame
    1 months
    Title
    Occurrence of radiolucent lesions at furcation or periapical region
    Description
    (binary yes/no)
    Time Frame
    3 months
    Title
    Occurrence of radiolucent lesions at furcation or periapical region
    Description
    (binary yes/no)
    Time Frame
    6 months
    Title
    Occurrence of radiolucent lesions at furcation or periapical region
    Description
    (binary yes/no)
    Time Frame
    12 months
    Title
    widening in the periodontal membrane space
    Description
    (binary yes/no)
    Time Frame
    1 month
    Title
    widening in the periodontal membrane space
    Description
    (binary yes/no)
    Time Frame
    3 months
    Title
    widening in the periodontal membrane space
    Description
    (binary yes/no)
    Time Frame
    6 months
    Title
    widening in the periodontal membrane space
    Description
    (binary yes/no)
    Time Frame
    12 months
    Title
    presence of internal or external root resorption
    Description
    (binary yes/no)
    Time Frame
    1 month
    Title
    presence of internal or external root resorption
    Description
    (binary yes/no)
    Time Frame
    3 months
    Title
    presence of internal or external root resorption
    Description
    (binary yes/no)
    Time Frame
    6 months
    Title
    presence of internal or external root resorption
    Description
    (binary yes/no)
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Medically free children. Age range from 4-7 years. Presence of lower second primary molars with deep carious occlusal lesion. No history of spontaneous pain (reversible pulpitis). Clinically: Absence of swelling, sinus, fistula, pain on percussion and tooth mobility. Radiographically: Absence of radiolucent lesions at furcation or periapical region and absence of internal or external root resorption. Exclusion Criteria: Uncooperative children. Any unmet previous criterion.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars

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