MEDCEM PC and MTA in Pulpotomies of Primary Molars

Phase 4

• Conditions: Evaluate the Effects of MEDCEM PC and MTA in Pulpotomies of Primary Molars.
• Interventions: Procedure: Pulpotomy

• Registration Number: NCT02291120
• Lead Sponsor: Universitat Internacional de Catalunya

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-06-27
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-11
• Last Update Submitted: 2014-11-11
• Study First Posted: 2014-11-14
• Last Update Posted: 2014-11-14
• Primary Completion: 2015-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MedCem Portland Cement (PC)	Pulpotomy	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
MTA	Pulpotomy	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.

Primary Outcome Measures

Name	Time	Method
Clinical success	24 months	No pain, no swelling, no fistula or sinus tract, no pathologic mobility
Radiographic success	24 months	No internal root resorption progressing into the bone, no external root resorption, no furcation and/or periapical bone destruction

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat del Valles, Barcelona, Spain