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MEDCEM PC and MTA in Pulpotomies of Primary Molars

Sponsor
Universitat Internacional de Catalunya (Other)
Overall Status
Unknown status
CT.gov ID
NCT02291120
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
33.1
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pulpotomy
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2014
Anticipated Primary Completion Date :
Oct 1, 2015
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: MTA

ProRoot® 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.

Procedure: Pulpotomy
Experimental: MedCem Portland Cement (PC)

MedCem 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

Procedure: Pulpotomy

Outcome Measures

Primary Outcome Measures

  1. Clinical success [24 months]

    No pain, no swelling, no fistula or sinus tract, no pathologic mobility

  2. Radiographic success [24 months]

    No internal root resorption progressing into the bone, no external root resorption, no furcation and/or periapical bone destruction

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • presence of systemic pathology

  • history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitat Internacional de Catalunya Sant Cugat del Valles Barcelona Spain 08195

Sponsors and Collaborators

  • Universitat Internacional de Catalunya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cristina Cuadros, Master's Program Director in Pediatric Dentistry, Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier:
NCT02291120
Other Study ID Numbers:
  • UIC-ODP-4
First Posted:
Nov 14, 2014
Last Update Posted:
Nov 14, 2014
Last Verified:
Nov 1, 2014

Study Results

No Results Posted as of Nov 14, 2014