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Trial record 4 of 47 for:    FERRIC SULFATE

Comparison of The Success Rates of Four Different Pulpotomy Techniques

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ClinicalTrials.gov Identifier: NCT03135626
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Yeliz Guven, Istanbul University

Brief Summary:
This randomized clinical trial was conducted to examine and compare the effectiveness of pulpotomy in primary molars treated with calcium silicate based materials including Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116 primary molars in 29 children were treated by pulpotomy and followed for a period of 24 months.

Condition or disease Intervention/treatment Phase
Extensive Decay in Primary Molars Drug: Biodentine Drug: ProRoot (Aggregate) Drug: MTA Plus Drug: Ferric Sulfate 20 % Dental Gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Split-mouth study design was used
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of The Success Rates of Four Different Pulpotomy Techniques
Actual Study Start Date : March 15, 2013
Actual Primary Completion Date : January 15, 2014
Actual Study Completion Date : February 15, 2016

Arm Intervention/treatment
Experimental: Biodentine
Biodentine pulpotomy agent
Drug: Biodentine
Other Name: 77509635

Experimental: ProRoot MTA
ProRoot MTA pulpotomy agent
Drug: ProRoot (Aggregate)
Other Name: 75896452

Experimental: MTA Plus
MTA Plus pulpotomy agent
Drug: MTA Plus
Other Name: 85303191

Active Comparator: Ferric Sulfate 20% Dental Gel
Ferric Sulfate %20 Dental Gel pulpotomy agent
Drug: Ferric Sulfate 20 % Dental Gel
Other Name: Viscostat




Primary Outcome Measures :
  1. Total success rate [ Time Frame: 6 months after pulpotomy treatment ]
    Number of molars with both clinically and radiographically successful

  2. Total success rate [ Time Frame: 12 months after pulpotomy treatment ]
    Number of molars with both clinically and radiographically successful

  3. Total success rate [ Time Frame: 24 months after pulpotomy treatment ]
    Number of molars with both clinically and radiographically successful



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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients were eligible if they were 5 to 7 years old, healthy and cooperative, and had at least four carious primary molars, each of which was in a different quadrant and required a pulpotomy. The criteria for the selection of the teeth to be included in the study were presence of deep caries, presence of at least two-thirds of the root length radiographically and being restorable.

Exclusion Criteria:

  • The exclusion criteria were the presence of any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL) space, furcal or periapical radiolucency and teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure. Teeth without permanent successor were not also included in the study.

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): NCT03135626


Sponsors and Collaborators
Istanbul University
Investigators
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Principal Investigator: Yeliz Guven, Dr. Istanbul University

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Responsible Party: Yeliz Guven, Dr, Istanbul University
ClinicalTrials.gov Identifier: NCT03135626     History of Changes
Other Study ID Numbers: 2012/1728-1288
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yeliz Guven, Istanbul University:
Pulpotomy
Primary molars
Additional relevant MeSH terms:
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Ferric Compounds
Hematinics