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CompletedNCT03718676Updated Mar 5, 2019

Pulpotomy With Various MTA Materials and Ferric Sulphate

An interventional study of Ferric sulphate and Ortho-MTA in Pulpotomy, sponsored by Aydin Adnan Menderes University. Completed at 1 site in Turkey. Open to participants aged 5 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-05.

Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jun 2017, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
5 Years to 9 Years
Sex
All
01

Study 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.

Read the detailed description

A total of 96 second primary second molars from 32 children ,who met inclusion criteria and were 5-9 years old were selected for the study. Teeth were randomly divided into three groups according to the planned treatment: O-MTA (n=32 teeth), R-MTA (n=32 teeth) and FS (n=32 teeth). Clinical and radiographical follow-up examinations were conducted at 3, 6 and 9 months postoperatively. The data were evaluated with Chi-square test, Cochran Q test, Post-Huc Dunn test and Kaplan-Meier analysis.

02

Conditions studied

  • Pulpotomy

Keywords

  • pulpotomy
03

In context

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients who are not willing to participate
  • History of systemic disease
  • Pathological mobility
  • Presence of internal or external root resorption
  • Presence of apical radiolucency
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
32 participants (actual)

Study arms

  • Other
    Ferric sulphate

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

    Procedure: Ferric sulphate

  • Experimental
    Orto-mta

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

    Procedure: Ortho-MTA

  • Experimental
    Retro-mta

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

    Procedure: Retro-MTA

Interventions

  • ProcedureFerric sulphate

    Teeth were pulpotomized with ferric sulphate in this group.

  • ProcedureOrtho-MTA

    Teeth were pulpotomized with Ortho-MTA in this group.

  • ProcedureRetro-MTA

    Teeth were pulpotomized with Retro-MTA in this group.

06

What researchers measure

Primary outcomes

  1. Clinical success rate

    Clinical success

    Time frame: Change of clinical success from Baseline at 18 months

07

Study locations

1 site
  • Sultan KELES
    Aydin, 09100, Turkey
08

References and documents

Publications

  • 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. PubMed 30292451 ↗

Individual participant data

Plan to share: Undecided — We will share the results.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03718676
Lead sponsor
Aydin Adnan Menderes University
Responsible party
Sultan KELES (Assist. Prof.Dr., Aydin Adnan Menderes University) — Principal investigator
First posted
Oct 24, 2018
Start date
Jun 2, 2017
Primary completion
Jun 30, 2018
Completion
Dec 30, 2018
Last update
Mar 5, 2019

Study contacts

sultan keles, Dr.
principal investigator · Pediatric dentistry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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