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

August 19, 2021 updated by: Amany hasanean Abd El sadek

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

  • 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: control group
the group of primary molar teeth that will be treated in furcal perforation with Mineral Trioxide Aggregate
Combination product: Mineral Trioxide Aggregate
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
Other Names:
  • MTA
Experimental: experimental group
the group of primary molar teeth that will be treated in furcal perforation with Biodentine
Combination product: Biodentine
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
sealing ability
Time Frame: 24 hours
  • measured by scanning electron microscope
  • Unit of measurement : µm
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amany hasanean Abd El sadek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1692

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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