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Human Pulpal Response After Pulp Capping With Four Different Agents

Primary Purpose

Dental Pulp Exposure

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pro Root MTA
Pro Root MTA- single visit
MultiCal
Dycal
Sponsored by
Islamic Azad University, Tehran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pulp Exposure focused on measuring direct pulp capping, MTA, Single visit pulp cap, Multical

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mahta Fazlyab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Pro Root MTA- standard method

Pro Root MTA- single visit

MultiCal / LimeLite

Dycal

Arm Description

application of MTA in second group and 24 hour interval before restoration

Intervention/Control application of MTA in third group and 15 minute interval before restoration

application of Multical in forth group

application of Dycal in first group as a pulp dressing agent

Outcomes

Primary Outcome Measures

histologic findings - inflammation of the pulp
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
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.

Full Information

First Posted
November 4, 2011
Last Updated
November 8, 2011
Sponsor
Islamic Azad University, Tehran
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1. Study Identification

Unique Protocol Identification Number
NCT01468480
Brief Title
Human Pulpal Response After Pulp Capping With Four Different Agents
Official Title
Comparison of Human Pulpal Response After Pulpal Exposure to Common Treatments and Single-visit MTA
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Islamic Azad University, Tehran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Exposure
Keywords
direct pulp capping, MTA, Single visit pulp cap, Multical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pro Root MTA- standard method
Arm Type
Experimental
Arm Description
application of MTA in second group and 24 hour interval before restoration
Arm Title
Pro Root MTA- single visit
Arm Type
Experimental
Arm Description
Intervention/Control application of MTA in third group and 15 minute interval before restoration
Arm Title
MultiCal / LimeLite
Arm Type
Experimental
Arm Description
application of Multical in forth group
Arm Title
Dycal
Arm Type
Active Comparator
Arm Description
application of Dycal in first group as a pulp dressing agent
Intervention Type
Drug
Intervention Name(s)
Pro Root MTA
Other Intervention Name(s)
Mineral Trioxide Aggregate
Intervention Description
application of MTA in second group and 24 hour interval before restoration
Intervention Type
Drug
Intervention Name(s)
Pro Root MTA- single visit
Other Intervention Name(s)
Mineral Trioxide Aggregate
Intervention Description
application of MTA in third group and 15 minute interval before restoration
Intervention Type
Drug
Intervention Name(s)
MultiCal
Other Intervention Name(s)
Hard set calcium hydroxide paste
Intervention Description
application of Multical in forth group as a pulp dressing agent
Intervention Type
Drug
Intervention Name(s)
Dycal
Other Intervention Name(s)
chemical set calcium hydroxide
Intervention Description
application of Dycal in first group as a pulp dressing agent
Primary Outcome Measure Information:
Title
histologic findings - inflammation of the pulp
Description
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.
Time Frame
6weeks
Secondary Outcome Measure Information:
Title
histologic findings - formation of the dentinal bridge
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahta Fazlyab, Resident
Organizational Affiliation
Fazlyab Mahta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahta Fazlyab
City
Tehran
ZIP/Postal Code
1946853314
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Human Pulpal Response After Pulp Capping With Four Different Agents

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