MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial
MTA/FS
Mineral Trioxide Aggregate/Ferric Sulfate Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial
1 other identifier
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
February 11, 2016
CompletedFebruary 11, 2016
February 1, 2016
3.7 years
December 18, 2013
July 20, 2015
February 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure.
Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.
12 months after the procedure
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure.
Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.
18 months after the procedure
Secondary Outcomes (3)
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure.
12 months after the procedure
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure.
18 months after the procedure
MTA/FS Pulpotomy and RCT Treated Incisor Survival
12 and 18 months
Study Arms (2)
MTA/FS pulpotomy Group
EXPERIMENTALChildren randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).
RCT Group
ACTIVE COMPARATORChildren randomized to this group will undergo the root canal therapy (RCT) technique.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- children with one or more carious primary maxillary incisors where removal of dental caries will likely to produce a vital pulp exposure
- English-speaking
You may not qualify if:
- history of spontaneous or lingering stimulated pain, swelling, fistula or sinus tract, tenderness to percussion and pathological mobility
- incisors with preoperative radiographic evidence of periapical or periradicular radiolucency, a widened periodontal ligament space, physiological resorption, incomplete root formation, internal or external root resorption, pulp canal obliteration or pulp calcifications
- non-restorable tooth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations of the study design included no blinding of personnel providing treatment or raters assessing clinical and radiographic outcomes.
Results Point of Contact
- Title
- Trang Nguyen
- Organization
- The Hospital for Sick Children
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Judd, DDS
The Hospital for Sick Children, Toronto Canada
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dentist-in-Chief
Study Record Dates
First Submitted
December 18, 2013
First Posted
December 24, 2013
Study Start
September 1, 2010
Primary Completion
May 1, 2014
Study Completion
September 1, 2014
Last Updated
February 11, 2016
Results First Posted
February 11, 2016
Record last verified: 2016-02