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Radiographic Assessment of Calcific Bridge Formation by Light Activated Calcium Silicate Versus Calcium Hydroxide for Deep Caries

Primary Purpose

Deep Carious Lesions

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
light activated calcium silicate
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Carious Lesions focused on measuring based dentin substitute, dentin bridge, tertiary dentin, indirect pulp treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Normal adults will be recruited in this study ,all the volunteers participated in this experiment will be healthy looking free medical history.
  • Patients have simple deep carious lesions in his /her mouth with no pain or history of sensitivity to cold which disappear immediately after removal of the stimulus.

Exclusion Criteria:

  • Medically compromised patients and teeth with history of spontaneous pain or tenderness to percussion were excluded from the study.
  • Pregnant females will be excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    light activated calcium silicate

    light activated calcium hydroxide

    Arm Description

    Apply light activated calcium silicate in deep occlusal caries lesions and taking the base line image for the first group after restoring the cavity with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.

    Apply the light activated calcium hydroxide in deep occlusal carious lesions and taking the base line image for the second group after restoring with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.

    Outcomes

    Primary Outcome Measures

    calcific bridge formation will be measured by digora software
    in millimeters

    Secondary Outcome Measures

    Full Information

    First Posted
    July 25, 2017
    Last Updated
    July 19, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03233893
    Brief Title
    Radiographic Assessment of Calcific Bridge Formation by Light Activated Calcium Silicate Versus Calcium Hydroxide for Deep Caries
    Official Title
    Radiographic Assessment of Calcific Bridge Formation by Light Activated Calcium Silicate Versus Light Activated Calcium Hydroxide in Management of Simple Deeply Seated Carious Lesions With Partial Caries Removal
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2018 (Anticipated)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 1, 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
    sixty participants will be divided in to two groups (n=30) of patient treated by partial caries removal according to the capping material (A),where (A1)represents calcium silicate group,(A2)represent calcium hydroxide group.Apply light activated calcium silicate for group (A1) in deep occlusal caries and taking the base line image after restoring the cavity with composite restoration and apply light activated calcium hydroxide for(A2)group in deep occlusal caries and taking the base line image after restoring with composite restoration.Take follow up image after one year to measure the calcific bridge formation for both groups.
    Detailed Description
    Management of deep carious lesion may constitute a real challenge for the operator.The basic idea for treating deep caries is to enhance calcific reparative capacity.Calcium hydroxide has been the gold standard as a capping material but there are some drawbacks like solubility,gaps formation and mechanical instability so a need for a capping material such as calcium silicate has shown several advantages. Sixty participants will be divided in to two groups (n=30) of patient treated by partial caries removal.The first group(A1) will be treated by light activated calcium silicate and the second group(A2) will be treated by light activated calcium hydroxide after partial caries removal of deep occlusal caries then restore by composite restoration.Paralleling technique using film holders and custom made bite blocks will be used to standardize the serial radiographs and to prevent the distortion of the radiographic image.An increase in dentin thickness will be measured through sequential imaging by soft ware named Digora (Digora Optime,Soredex,Helsinki,Finland) will be used for measurements by digitalizing the scanned image.All images will be studied carefully for an increase in dentin thickness keeping the reference point constant from the furcation area.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deep Carious Lesions
    Keywords
    based dentin substitute, dentin bridge, tertiary dentin, indirect pulp treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    The patient and the outcome assessor will be blinded in this study
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    light activated calcium silicate
    Arm Type
    Experimental
    Arm Description
    Apply light activated calcium silicate in deep occlusal caries lesions and taking the base line image for the first group after restoring the cavity with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.
    Arm Title
    light activated calcium hydroxide
    Arm Type
    Active Comparator
    Arm Description
    Apply the light activated calcium hydroxide in deep occlusal carious lesions and taking the base line image for the second group after restoring with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.
    Intervention Type
    Other
    Intervention Name(s)
    light activated calcium silicate
    Other Intervention Name(s)
    light activated calcium hydroxide
    Intervention Description
    for the first group light activated calcium silicate can be easily placed by a 20 second light cure and ability to be syringed directly on to the cavity preparation and restore the cavity by composite restoration. for the second group using light activated calcium hydroxide is placed by placing a disposable tip securely on to the syringe then light cure for 20 seconds depending on the light cure unit and restore the cavity with composite restoration.
    Primary Outcome Measure Information:
    Title
    calcific bridge formation will be measured by digora software
    Description
    in millimeters
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Normal adults will be recruited in this study ,all the volunteers participated in this experiment will be healthy looking free medical history. Patients have simple deep carious lesions in his /her mouth with no pain or history of sensitivity to cold which disappear immediately after removal of the stimulus. Exclusion Criteria: Medically compromised patients and teeth with history of spontaneous pain or tenderness to percussion were excluded from the study. Pregnant females will be excluded from the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    basma gamal hassan, master
    Phone
    01011137104
    Email
    basmadental1@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    basma gamal hassan, master
    Phone
    01011137104
    Email
    basmadental1@gmail.om

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27994411
    Citation
    Grewal N, Salhan R, Kaur N, Patel HB. Comparative evaluation of calcium silicate-based dentin substitute (Biodentine(R)) and calcium hydroxide (pulpdent) in the formation of reactive dentin bridge in regenerative pulpotomy of vital primary teeth: Triple blind, randomized clinical trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):457-463. doi: 10.4103/0976-237X.194116.
    Results Reference
    result
    Links:
    URL
    http://www.contempclindent.org
    Description
    comparative evaluation of calcium silicate -based dentin substitute (Biodentine) and calcium hydroxide (pulpdent) in the formation of reactive dentin bridge in regenerative pulpotomy of vital primary teeth

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    Radiographic Assessment of Calcific Bridge Formation by Light Activated Calcium Silicate Versus Calcium Hydroxide for Deep Caries

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