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

NCT ID: NCT05006755

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2022-09-10

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

Conditions

Tooth Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

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

Group Type: EXPERIMENTAL

Mineral Trioxide Aggregate

Intervention Type: COMBINATION_PRODUCT

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

experimental group

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

Group Type: EXPERIMENTAL

Biodentine

Intervention Type: COMBINATION_PRODUCT

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

Interventions

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

Intervention Type: 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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

MTA

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amany hasanean Abd El sadek

OTHER

Sponsor Role: lead

Responsible Party

Amany hasanean Abd El sadek

student

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

1692

Identifier Type: -

Identifier Source: org_study_id