CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
RCT Group +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02019563
NCT02019563Phase 2Completed
CompareCT.gov

Mineral Trioxide Aggregate/Ferric Sulfate Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial

The Hospital for Sick Children·interventional·Posted Dec 24, 2013·Updated Feb 11, 2016

In Brief

A Phase 2 clinical trial evaluating RCT Group and MTA/FS pulpotomy Group for Dental Caries and Dental Pulp Exposure. Completed, enrolled 70 participants across 1 site.

Detailed Summary

To compare radiographic and clinical outcomes and survival of mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy and root canal therapy (RCT) in carious vital primary maxillary incisors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries, Dental Pulp Exposure
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2013
Enrollment StartSep 1, 2010
Primary CompletionMay 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 12.5 years ago

Interventions

RCT Groupprocedure

After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE.

MTA/FS pulpotomy Groupprocedure

After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface.