MEDCEM PC and MTA in Pulpotomies of Primary Molars

NCT ID: NCT02291120

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Evaluate the Effects of MEDCEM PC and MTA in Pulpotomies of Primary Molars.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Pulpotomy

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

Pulpotomy

Intervention Type PROCEDURE

Interventions

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Pulpotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitat Internacional de Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Cristina Cuadros

Master's Program Director in Pediatric Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Cristina Cuadros Fernandez, DDS, MsC

Role: primary

0034 93 5045000

Other Identifiers

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UIC-ODP-4

Identifier Type: -

Identifier Source: org_study_id