NCT03718676

Brief Summary

The aim of this study was to determine clinical and radiographic efficacy of the newly developed OrthoMTA and RetroMTA , compared frequently used ferric sulfate for pulpotomy in primary second molars.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

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

Study Start

First participant enrolled

June 2, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

March 5, 2019

Status Verified

October 1, 2018

Enrollment Period

1.1 years

First QC Date

October 22, 2018

Last Update Submit

March 4, 2019

Conditions

Pulpotomy

Keywords

pulpotomy

Outcome Measures

Primary Outcomes (1)

  • Clinical success rate

    Clinical success

    Change of clinical success from Baseline at 18 months

Study Arms (3)

Ferric sulphate

OTHER

Group FS. Teeth in this goup will pulpotomized with ferris-sulphate.

Procedure: Ferric sulphate

Orto-mta

EXPERIMENTAL

Group O-MTA.Teeth in this goup will pulpotomized with Ortho-mta.

Procedure: Ortho-MTA

Retro-mta

EXPERIMENTAL

Group R-MTA. Teeth in this goup will pulpotomized with Retro-mta.

Procedure: Retro-MTA

Interventions

Ferric sulphatePROCEDURE

Teeth were pulpotomized with ferric sulphate in this group.

Ferric sulphate
Ortho-MTAPROCEDURE

Teeth were pulpotomized with Ortho-MTA in this group.

Orto-mta
Retro-MTAPROCEDURE

Teeth were pulpotomized with Retro-MTA in this group.

Retro-mta

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients have at least three deep carious primary second molars
  • Teeth with no spontaneous pain
  • Patient who are willing to participate
  • Cooperative children

You may not qualify if:

  • Patients who are not willing to participate
  • History of systemic disease
  • Pathological mobility
  • Presence of internal or external root resorption
  • Presence of apical radiolucency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan KELES

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (1)

  • Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3.

    PMID: 30292451BACKGROUND

Study Officials

  • sultan keles, Dr.

    Pediatric dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.Dr.

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 24, 2018

Study Start

June 2, 2017

Primary Completion

June 30, 2018

Study Completion

December 30, 2018

Last Updated

March 5, 2019

Record last verified: 2018-10

Locations

TU(1)