Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics (A Randomized Clinical Trial)

NCT ID: NCT04137861

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-25

Study Completion Date

2020-10-25

Brief Summary

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Furcal perforation is one of the most challenging procedural accidents during pulpotomy of primary molars and should be sealed as soon as possible to prevent bacterial invasion at perforation site and subsequent tooth extraction. The aim of the study is to compare bioceramics versus MTA as root repair material for treatment of furcal perforation in primary molars

Detailed Description

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Conditions

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Iatrogenic Perforation of Primary Molars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mineral Trioxide Aggregate (MTA)

Root repair material

Group Type ACTIVE_COMPARATOR

Bioceramics

Intervention Type OTHER

root repair material

bioceramics

Root repair material

Group Type EXPERIMENTAL

Bioceramics

Intervention Type OTHER

root repair material

Interventions

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Bioceramics

root repair material

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Apparently healthy children aged from 4 to 7 years
* No history of spontaneous pain or swelling
* No signs or symptoms of irreversible pulpits or loss of vitality
* Absence of radicular or priapical lesions.
* Accidental furcal perforation should be immediate or mediate (within two weeks) perforation in primary molars.

Exclusion Criteria

* Children with systemic disease
* Presence of priapical lesions
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ahmad Elheeny

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Elheeny

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Minia University

Minya, , Egypt

Site Status

Countries

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Egypt

References

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Abdelmotelb MA, Gomaa YF, Khattab NMA, Elheeny AAH. Premixed bioceramics versus mineral trioxide aggregate in furcal perforation repair of primary molars: in vitro and in vivo study. Clin Oral Investig. 2021 Aug;25(8):4915-4925. doi: 10.1007/s00784-021-03800-3. Epub 2021 Jan 22.

Reference Type DERIVED
PMID: 33483869 (View on PubMed)

Other Identifiers

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308

Identifier Type: -

Identifier Source: org_study_id

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