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Class II Restoration Using Bioactive Restorative Material vs Polyacid Modified Composite Resin in Primary Molars

Primary Purpose

Class II Dental Caries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ACTIVA Bioactive restoration
Compomer restoration
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Dental Caries

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Children with Class II cavities in vital primary second molars.
  2. Proximal enamel/dentin caries limited to outer half of dentin.
  3. Age ranging from 4-8 years.
  4. Good general health.

Exclusion Criteria:

  1. Spontaneous pain related to carious molars.
  2. Abscess or fistula on examination or during history taking.
  3. Tooth mobility.
  4. Radiographic evidence of root resorption or close shedding time.
  5. Lack of patient co-operation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ACTIVA Test arm

    Compomer Comparator arm

    Arm Description

    Treatment of decay in Class II second primary molars using ACTIVA restorative material.

    Treatment of decay in Class II second primary molars using compomer restorative material.

    Outcomes

    Primary Outcome Measures

    Post-operative sensitivity
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).

    Secondary Outcome Measures

    Color match
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Marginal discoloration
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Marginal adaptation (integrity)
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Surface texture
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Anatomic form
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Gross/restoration fracture
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Tooth fracture
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Secondary caries
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration and (C) = clinically unacceptable restorations (failure).
    Pulpal affection
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration and (C) = clinically unacceptable restorations (failure).

    Full Information

    First Posted
    July 18, 2019
    Last Updated
    July 19, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04030117
    Brief Title
    Class II Restoration Using Bioactive Restorative Material vs Polyacid Modified Composite Resin in Primary Molars
    Official Title
    Clinical and Radiographic Assessment of Bioactive Restorative Material Versus Polyacid Modified Composite Resin in Treatment of Class II Restorations in Primary Molars: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2019 (Anticipated)
    Primary Completion Date
    June 2020 (Anticipated)
    Study Completion Date
    September 2020 (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
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Successful restoration of cavities in primary molars can be considered challenging. It is different from restoring cavities in permanent molars because factors such as the level of co-operation of the child and the handling properties and setting time of the restorative material will have some influence on the success rate of the restoration. The ideal requirements that a filling material should possess include that it bears the occlusal force, withstands the acidic and bacterial attack, survives in the oral environment in addition to being biocompatible with the oral tissues. In an attempt to achieve this idealism, a new class of restorative materials known as "bioactive materials" has been developed. The concept of bioactive materials was introduced in 1969 and later defined as "one that elicits a specific biological response at the interface of the material which results in the formation of a bond between tissues and the material." An example of bioactive materials is ACTIVA™ BioACTIVE (Pulpdent, USA). These materials are ionic composite resins which combine the biocompatibility, chemical bond and the ability to release fluoride of glass ionomers with the mechanical properties, esthetic and durability of composite resins. Compomer is widely accepted as a standard restorative material for primary dentition for Class I and II cavities. Its range of success rate in Class II restorations in primary molars is 78-96%. Many randomized clinical trials have reported comparable clinical performance to composite resin with respect to color matching, marginal discoloration, anatomical form, marginal integrity and secondary caries. In comparison to glass ionomer and Resin Modified Glass Ionomer, compomers tend to have better physical properties in the primary dentition. However, their cariostatic properties didn't differ significantly from those materials.
    Detailed Description
    Hypothesis: The null hypothesis is that there is no difference between using ACTIVA and Dyract® in children to restore Class II cavities in carious vital primary second molars. Trial design: A pilot study, parallel group, two arm. Allocation ratio is 1:1. Method Intervention: A) Diagnosis: Diagnostic chart will be filled with personal, medical and dental history. The intra-oral examination will be made using gloves, mask, gauze and dental mirror. A pre-operative radiograph (bitewing) will be taken for diagnosis. b) The intervention in this pilot study will be (ACTIVA™ BioACTIVE, Pulpdent, USA) - Gp1 while the comparator will be (Dyract® DENTSPLY, Germany)- Gp2. Three follow up visits for restoration at: T1 (3 months), T2 (6 months) and T3 (12 months). Same procedure in both groups will be followed: The tooth will be anesthetized using local anesthesia, and isolated using rubber dam. Caries will be removed. A proximal box is prepared. A metal matrix band is fixed around the tooth and a wedge is placed interdentally. The restorative material chosen according to the randomization is placed in the cavity according to the manufacturer's instructions. A post-operative digital bitewing radiograph will be taken immediately after the treatment as a base line reference and to check for voids or any defect in the restoration.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ACTIVA Test arm
    Arm Type
    Experimental
    Arm Description
    Treatment of decay in Class II second primary molars using ACTIVA restorative material.
    Arm Title
    Compomer Comparator arm
    Arm Type
    Active Comparator
    Arm Description
    Treatment of decay in Class II second primary molars using compomer restorative material.
    Intervention Type
    Procedure
    Intervention Name(s)
    ACTIVA Bioactive restoration
    Other Intervention Name(s)
    ACTIVA Bioactive Class II restoration
    Intervention Description
    Removal of Class II decay in second primary molars and placement of ACTIVA restoration.
    Intervention Type
    Procedure
    Intervention Name(s)
    Compomer restoration
    Other Intervention Name(s)
    Compomer Class II restoration
    Intervention Description
    Removal of Class II decay in second primary molars and placement of Compomer restoration.
    Primary Outcome Measure Information:
    Title
    Post-operative sensitivity
    Description
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Color match
    Description
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Time Frame
    12 months
    Title
    Marginal discoloration
    Description
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Time Frame
    12 months
    Title
    Marginal adaptation (integrity)
    Description
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Time Frame
    12 months
    Title
    Surface texture
    Description
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Time Frame
    12 months
    Title
    Anatomic form
    Description
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Time Frame
    12 months
    Title
    Gross/restoration fracture
    Description
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Time Frame
    12 months
    Title
    Tooth fracture
    Description
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
    Time Frame
    12 months
    Title
    Secondary caries
    Description
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration and (C) = clinically unacceptable restorations (failure).
    Time Frame
    12 months
    Title
    Pulpal affection
    Description
    Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration and (C) = clinically unacceptable restorations (failure).
    Time Frame
    12 months
    Other Pre-specified Outcome Measures:
    Title
    Secondary/recurrent caries
    Description
    Using standardized bite-wing radiograph to check presence or absence of secondary caries.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children with Class II cavities in vital primary second molars. Proximal enamel/dentin caries limited to outer half of dentin. Age ranging from 4-8 years. Good general health. Exclusion Criteria: Spontaneous pain related to carious molars. Abscess or fistula on examination or during history taking. Tooth mobility. Radiographic evidence of root resorption or close shedding time. Lack of patient co-operation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reem Moustafa
    Phone
    00201111254041
    Email
    reem.m.moustafa87@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cairo University
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    After thesis defense the study will be published internationally to be available for the public.
    IPD Sharing Time Frame
    Data will be available within one year and a half
    IPD Sharing Access Criteria
    Not yet

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    Class II Restoration Using Bioactive Restorative Material vs Polyacid Modified Composite Resin in Primary Molars

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