NCT04137861

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

October 25, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2020

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

October 20, 2019

Last Update Submit

February 23, 2021

Conditions

Iatrogenic Perforation of Primary Molars

Outcome Measures

Primary Outcomes (2)

  • clinical success

    Visual oral examination

    9 months

  • radiographic success

    Radiolucency assessment (+/-)

    9 months

Study Arms (2)

Mineral Trioxide Aggregate (MTA)

ACTIVE COMPARATOR

Root repair material

Other: Bioceramics

bioceramics

EXPERIMENTAL

Root repair material

Other: Bioceramics

Interventions

BioceramicsOTHER

root repair material

Mineral Trioxide Aggregate (MTA)bioceramics

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with systemic disease
  • Presence of priapical lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, 61111, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 33483869DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 20, 2019

First Posted

October 24, 2019

Study Start

October 25, 2019

Primary Completion

August 25, 2020

Study Completion

October 25, 2020

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations

EG(1)