NCT05006755

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Status
unknown

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

August 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

September 10, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

Same day

First QC Date

August 9, 2021

Last Update Submit

August 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • sealing ability

    * measured by scanning electron microscope * Unit of measurement : µm

    24 hours

Study Arms (2)

control group

EXPERIMENTAL

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

Combination Product: Mineral Trioxide Aggregate

experimental group

EXPERIMENTAL

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

Combination Product: Biodentine

Interventions

Mineral Trioxide AggregateCOMBINATION_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

Also known as: MTA
control group
BiodentineCOMBINATION_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

experimental group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Exfoliated primary molars
  • Primary molars with internal resorption
  • Primary molars with extensive tooth decay of the crown
  • Primary molars with discoloration
  • Cracked tooth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Injuries

Interventions

mineral trioxide aggregatePemetrexedtricalcium silicate

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
student

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 16, 2021

Study Start

September 10, 2021

Primary Completion

September 10, 2021

Study Completion

September 10, 2022

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share