Comparison of The Success Rates of Four Different Pulpotomy Techniques

Extensive Decay in Primary Molars Clinical Trial

Official title:

Comparison of The Success Rates of Four Different Pulpotomy Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135626
• Other study ID #: 2012/1728-1288
• Status: Completed
• Phase: Phase 3
• First received: April 26, 2017
• Last updated: April 28, 2017
• Start date: March 15, 2013
• Est. completion date: February 15, 2016

Study information

• Verified date: April 2017
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 15, 2016
• Est. primary completion date: January 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extensive Decay in Primary Molars

Intervention

Drug:
• Biodentine

• ProRoot (Aggregate)

• MTA Plus

• Ferric Sulfate 20 % Dental Gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total success rate	Number of molars with both clinically and radiographically successful	6 months after pulpotomy treatment
Primary	Total success rate	Number of molars with both clinically and radiographically successful	12 months after pulpotomy treatment
Primary	Total success rate	Number of molars with both clinically and radiographically successful	24 months after pulpotomy treatment