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Comparison of Sealing Ability of MTA and Biodentine for Repairing of Furcal Perforation in Primary Molars

Primary Purpose

Tooth Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mineral Trioxide Aggregate
Biodentine
Sponsored by
Amany hasanean Abd El sadek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Injuries

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Freshly extracted discarded primary molars
  • Primary molars with intact furcation ( no caries, no perforation, no resorption )
  • Physiologic root resorption not more than two-third of root length

Exclusion Criteria:

  • Exfoliated primary molars
  • Primary molars with internal resorption
  • Primary molars with extensive tooth decay of the crown
  • Primary molars with discoloration
  • Cracked tooth

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    control group

    experimental group

    Arm Description

    the group of primary molar teeth that will be treated in furcal perforation with Mineral Trioxide Aggregate

    the group of primary molar teeth that will be treated in furcal perforation with Biodentine

    Outcomes

    Primary Outcome Measures

    sealing ability
    measured by scanning electron microscope Unit of measurement : µm

    Secondary Outcome Measures

    Full Information

    First Posted
    August 9, 2021
    Last Updated
    August 19, 2021
    Sponsor
    Amany hasanean Abd El sadek
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05006755
    Brief Title
    Comparison of Sealing Ability of MTA and Biodentine for Repairing of Furcal Perforation in Primary Molars
    Official Title
    Comparison of Sealing Ability of Mineral Trioxide Aggregate and Biodentine for Reparing of Furcal Perforation in Primary Molars Using Scanning Electron Microscope: In Vitro Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 10, 2021 (Anticipated)
    Primary Completion Date
    September 10, 2021 (Anticipated)
    Study Completion Date
    September 10, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Amany hasanean Abd El sadek

    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
    Preservation of the primary teeth is a mandatory issue for maintaining the integrity of the normal dentition and functioning till the eruption of the successors. furcal perforations may occur due to iatrogenic and non-iatrogenic causes. Despite the high successful outcomes in perforation repair with MTA, there are some issues which prevent the clinicians from using it for many cases such as its very long setting time and its difficult manipulation. Biodentin could be used as an alternative to MTA in reparative treatment procedures due to its ability to provide a hermetic seal and durable restoration and thus an optimal sealing is expected. The importance of the trial lies in testing the sealing ability of Biodentine using scanning electron microscope. Biodentine has short setting time and is easier in manipulation than MTA which are major needs when dealing with pediatric patients to be able to give best results in short time.
    Detailed Description
    By immediate diagnosis and sealing of furcal perforations in primary molar teeth with a biocompatible material, the prognosis is usually favorable. MTA has high clinical efficacy, but there were some drawbacks which made it difficult for the clinicians to use it in many cases. The major ones being very long setting time and difficult manipulation. Biodentine has a good sealing ability, high compressive strengths, short setting time, biocompatibility, bioactivity and biomineralization properties that make it available to be used in endodontic repair procedures. 42 extracted primary molar teeth will be collected, sterilized and stored according to the Occupational Safety and Health Administration guidelines and regulations. A standard access cavity will be prepared in each tooth using a diamond bur and non-end cutting bur in high-speed handpiece with water spray. A 0.5 mm round bur will be used to standardize the size of furcal perforation, and the furcal involvement will be made on the center of the pulpal floor. After the furcal perforation, the blocks will randomly be divided into two groups Control group: MTA Group, Using amalgam applicator the material will be carried and sealed in the furcation site. Intervention group: Biodentin Group,The material will be scooped and applied on the perforation site. Outcome : sealing ability measurement method : scanning electron microscope unit of measurement : µm

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Experimental
    Arm Description
    the group of primary molar teeth that will be treated in furcal perforation with Mineral Trioxide Aggregate
    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    the group of primary molar teeth that will be treated in furcal perforation with Biodentine
    Intervention Type
    Combination Product
    Intervention Name(s)
    Mineral Trioxide Aggregate
    Other Intervention Name(s)
    MTA
    Intervention Description
    Mineral Trioxide Aggregate stimulates cementoblasts to produce matrix for cementum formation and is biocompatible with the periradicular tissues thus shows a superior sealing ability when used in perforation repair
    Intervention Type
    Combination Product
    Intervention Name(s)
    Biodentine
    Intervention Description
    Biodentine has a good sealing ability, high compressive strengths, short setting time, biocompatibility, bioactivity and biomineralization properties that make it available to be used in endodontic repair procedures
    Primary Outcome Measure Information:
    Title
    sealing ability
    Description
    measured by scanning electron microscope Unit of measurement : µm
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Freshly extracted discarded primary molars Primary molars with intact furcation ( no caries, no perforation, no resorption ) Physiologic root resorption not more than two-third of root length Exclusion Criteria: Exfoliated primary molars Primary molars with internal resorption Primary molars with extensive tooth decay of the crown Primary molars with discoloration Cracked tooth

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison of Sealing Ability of MTA and Biodentine for Repairing of Furcal Perforation in Primary Molars

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