Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 47 for:    FERRIC SULFATE

Pulpotomy With Various MTA Materials and Ferric Sulphate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03718676
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sultan KELES, Aydin Adnan Menderes University

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.

Condition or disease Intervention/treatment Phase
Pulpotomy Procedure: Ferric sulphate Procedure: Ortho-MTA Procedure: Retro-MTA Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical and Radiographic Comparison of RetroMTA, OrthoMTA And Ferric Sulfate for Pulpotomy in Primary Molars
Actual Study Start Date : June 2, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Ferric sulphate
Group FS. Teeth in this goup will pulpotomized with ferris-sulphate.
Procedure: Ferric sulphate
Teeth were pulpotomized with ferric sulphate in this group.

Experimental: Orto-mta
Group O-MTA.Teeth in this goup will pulpotomized with Ortho-mta.
Procedure: Ortho-MTA
Teeth were pulpotomized with Ortho-MTA in this group.

Experimental: Retro-mta
Group R-MTA. Teeth in this goup will pulpotomized with Retro-mta.
Procedure: Retro-MTA
Teeth were pulpotomized with Retro-MTA in this group.




Primary Outcome Measures :
  1. Clinical success rate [ Time Frame: Change of clinical success from Baseline at 18 months ]
    Clinical success



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718676


Locations
Layout table for location information
Turkey
Sultan KELES
Aydin, Turkey, 09100
Sponsors and Collaborators
Aydin Adnan Menderes University
Investigators
Layout table for investigator information
Principal Investigator: sultan keles, Dr. Pediatric dentistry

Publications:
Layout table for additonal information
Responsible Party: Sultan KELES, Assist. Prof.Dr., Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03718676     History of Changes
Other Study ID Numbers: 2018-047
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will share the results.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sultan KELES, Aydin Adnan Menderes University:
pulpotomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Ferric Compounds
Hematinics