MEDCEM PC and MTA in Pulpotomies of Primary Molars

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.

Study Overview

• Status: Unknown
• Conditions: Evaluate the Effects of MEDCEM PC and MTA in Pulpotomies of Primary Molars.
• Intervention / Treatment: Procedure: Pulpotomy

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Cugat del Valles, Barcelona, Spain, 08195
      • Recruiting
      • Universitat Internacional de Catalunya
      • Contact: Cristina Cuadros Fernandez, DDS, MsC; Phone Number: 0034 93 5045000; Email: cuadros@uic.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: November 11, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Estimate): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 11, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: UIC-ODP-4