MEDCEM PC and MTA in Pulpotomies of Primary Molars
1 other identifier
interventional
80
1 country
1
Brief Summary
The objective of the study is to evaluate and compare, clinically and radiographically,the effects of MEDCEM PC and MTA when used as pulp dressings following pulpotomy in human primary molars.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2014
Typical duration for phase_4
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
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 27, 2014
CompletedFirst Posted
Study publicly available on registry
November 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 14, 2014
November 1, 2014
1.6 years
June 27, 2014
November 11, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Clinical success
No pain, no swelling, no fistula or sinus tract, no pathologic mobility
24 months
Radiographic success
No internal root resorption progressing into the bone, no external root resorption, no furcation and/or periapical bone destruction
24 months
Study Arms (2)
MTA
ACTIVE COMPARATORProRoot® MTA is a root canal repair material that is a unique improvement over other materials used for root canal repair. Made up of fine hydrophilic particles that set in the presence of water, ProRoot® MTA seals off all pathways between the root canal system and surrounding tissues, significantly reducing bacterial migration. Its excellent compatibility with the dentinal wall allows for a predictable clinical healing response.
MedCem Portland Cement (PC)
EXPERIMENTALMedCem PC is an excellent capping material for cariology on permanent teeth (direct and indirect capping) and in milk tooth endodontics (milk tooth amputation). Is characterized by excellent colour stability and neutrality and does not contain any additional ingredients
Interventions
Eligibility Criteria
You may qualify if:
- healthy children
- molars showing: symptomless exposure of vital pulp by caries no clinical or radiographic evidence of pulp degeneration (excessive bleeding from the root canal, internal root resorption, inter-radicular and/or furcal bone destruction) the possibility of proper restoration of the teeth no physiological resorption of more than one-third of the root
You may not qualify if:
- presence of systemic pathology
- history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master's Program Director in Pediatric Dentistry
Study Record Dates
First Submitted
June 27, 2014
First Posted
November 14, 2014
Study Start
March 1, 2014
Primary Completion
October 1, 2015
Study Completion
December 1, 2016
Last Updated
November 14, 2014
Record last verified: 2014-11