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
About this trial
This is an interventional treatment trial for Tooth Injuries
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
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
NCT ID
NCT05006755
First Posted
August 9, 2021
Last Updated
August 19, 2021
Sponsor
Amany hasanean Abd El sadek
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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