Human Pulpal Response After Pulp Capping With Four Different Agents

November 8, 2011 updated by: Mahta Fazlyab, Islamic Azad University, Tehran

Comparison of Human Pulpal Response After Pulpal Exposure to Common Treatments and Single-visit MTA

Application of four different pulp capping methods on human sound premolars after intentional exposure of the buccal pulp horn through a class one occlusal cavity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this clinical trial is to compare the effect of different direct pulp capping methods on human pulpal response in the terms of inflammation & dentinal bridge formation. Methods: Eight patients providing 32 sound first premolars are selected. As recommended by ISO / TC 7405 pulpal exposure will be performed through a class I cavity. Four groups of eight specimens each will be defined according to the pulp capping method. Group A, will receive chemical set calcium hydroxide (Dycal). Group B, will receive mineral Trioxide Aggregate (MTA) according to manufacturer's instruction. Group C, will receive MTA and after its primary setting, within 15 minutes, the cavity is restored in the same appointment. Group D, will receive Multical as a direct pulp capping agent. Specimens will be assessed in the terms of dentinal bridge formation, its appearance compared to natural dentin, its thickness and inflammatory pulpal response. The last item will be scored 0-3 in which 0 corresponds to none, 1 to minimal, 2 to moderate and 3 to severe inflammation. In case of an abscess or true tissue necrosis, a score of 4 will be given as recommended by ISO / TC 7405.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aging from 10 to 16
  • Patients who need to extract 4 premolars for orthodontic purposes
  • the teeth should be free of caries and clinical symptoms
  • Through thermal tests and radiographic examination absence of any pathology is confirmed.
  • Periapical radiographs demonstrating absence of any pathology
  • no sensitivity to percussion, palpation and biting, no sensitivity to cold after 5 seconds contact with Green Endo Ice refrigerant spray, heat sensitivity after applying tempered Gutta Percha for 10 seconds.
  • Absence of any systematic disorder
  • No consumption of drugs of any kind
  • All patients and their parents need to sign a fully informed consent.

Exclusion Criteria:

  • If any of the teeth shows caries, restoration, crack or hypocalcification
  • presence of any periapical pathosis
  • Teeth that seem sensitive to cold, hot, percussion or pressure
  • any systematic disorder
  • consumption of drugs of any kind.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pro Root MTA- standard method
application of MTA in second group and 24 hour interval before restoration
Drug: Pro Root MTA
application of MTA in second group and 24 hour interval before restoration
Other Names:
  • Mineral Trioxide Aggregate
Experimental: Pro Root MTA- single visit
Intervention/Control application of MTA in third group and 15 minute interval before restoration
Drug: Pro Root MTA- single visit
application of MTA in third group and 15 minute interval before restoration
Other Names:
  • Mineral Trioxide Aggregate
Experimental: MultiCal / LimeLite
application of Multical in forth group
Drug: MultiCal
application of Multical in forth group as a pulp dressing agent
Other Names:
  • Hard set calcium hydroxide paste
Active Comparator: Dycal
application of Dycal in first group as a pulp dressing agent
Drug: Dycal
application of Dycal in first group as a pulp dressing agent
Other Names:
  • chemical set calcium hydroxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
histologic findings - inflammation of the pulp
Time Frame: 6weeks
According to histological evaluation and ISO/DIS7405, the investigators gave to non inflamed cases no points, mild cases 1 point, moderate cases 2 points, severe cases 3 points and necrosis 4 points.
6weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
histologic findings - formation of the dentinal bridge
Time Frame: 6 weeks
The specimens will be evaluated in the terms of dentinal bridge formation and its resemblence to natural dentin and also the thickness of the bridge.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Islamic Azad University, Tehran

Investigators

  • Principal Investigator: Mahta Fazlyab, Resident, Fazlyab Mahta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

November 9, 2011

Last Update Submitted That Met QC Criteria

November 8, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • p/261/d

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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