Human Pulpal Response After Pulp Capping With Four Different Agents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mahta Fazlyab, Islamic Azad University, Tehran
ClinicalTrials.gov Identifier:
NCT01468480
First received: November 4, 2011
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Dental Pulp Exposure
Drug: Pro Root MTA
Drug: Pro Root MTA- single visit
Drug: MultiCal
Drug: Dycal
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Human Pulpal Response After Pulpal Exposure to Common Treatments and Single-visit MTA

Further study details as provided by Islamic Azad University, Tehran:

Primary Outcome Measures:
  • histologic findings - inflammation of the pulp [ Time Frame: 6weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • histologic findings - formation of the dentinal bridge [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 32
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: chemical set calcium hydroxide

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.

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01468480

Locations
Iran, Islamic Republic of
Mahta Fazlyab
Tehran, Iran, Islamic Republic of, 1946853314
Sponsors and Collaborators
Islamic Azad University, Tehran
Investigators
Principal Investigator: Mahta Fazlyab, Resident Fazlyab Mahta
  More Information

No publications provided

Responsible Party: Mahta Fazlyab, Post graduate student of endodontics, Islamic Azad University, Tehran
ClinicalTrials.gov Identifier: NCT01468480     History of Changes
Other Study ID Numbers: p/261/d
Study First Received: November 4, 2011
Last Updated: November 8, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Islamic Azad University, Tehran:
direct pulp capping
MTA
Single visit pulp cap
Multical

Additional relevant MeSH terms:
Dental Pulp Exposure
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 22, 2014