Comparison of The Success Rates of Four Different Pulpotomy Techniques
1 other identifier
interventional
38
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2013
Typical duration for phase_3
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
March 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2016
CompletedFirst Submitted
Initial submission to the registry
April 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 1, 2017
CompletedMay 1, 2017
April 1, 2017
10 months
April 26, 2017
April 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Total success rate
Number of molars with both clinically and radiographically successful
6 months after pulpotomy treatment
Total success rate
Number of molars with both clinically and radiographically successful
12 months after pulpotomy treatment
Total success rate
Number of molars with both clinically and radiographically successful
24 months after pulpotomy treatment
Study Arms (4)
Biodentine
EXPERIMENTALBiodentine pulpotomy agent
ProRoot MTA
EXPERIMENTALProRoot MTA pulpotomy agent
MTA Plus
EXPERIMENTALMTA Plus pulpotomy agent
Ferric Sulfate 20% Dental Gel
ACTIVE COMPARATORFerric Sulfate %20 Dental Gel pulpotomy agent
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yeliz Guven, Dr.
Istanbul University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
April 26, 2017
First Posted
May 1, 2017
Study Start
March 15, 2013
Primary Completion
January 15, 2014
Study Completion
February 15, 2016
Last Updated
May 1, 2017
Record last verified: 2017-04