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

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: Not yet recruiting
• Conditions: Tooth Injuries
• Intervention / Treatment: Combination product: Mineral Trioxide Aggregate; Combination product: Biodentine

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: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
sealing ability	measured by scanning electron microscope; Unit of measurement : µm	24 hours

Collaborators and Investigators

• Sponsor: Amany hasanean Abd El sadek

Study record dates

Study Major Dates

• Study Start (Anticipated): September 10, 2021
• Primary Completion (Anticipated): September 10, 2021
• Study Completion (Anticipated): September 10, 2022

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Tooth Diseases; Tooth Injuries
• Other Study ID 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