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Partial Pulpotomy on Caries Free Human Teeth

Primary Purpose

Dentin Bridge, Pulpitis

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
MTA
iRoot BP
Sponsored by
Islamic Azad University, Tehran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Bridge focused on measuring partial pulpotomy, Cvek pulpotomy, MTA, iRootBP, dentin bridge

Eligibility Criteria

10 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who are assigned to extract two premolar teeth in one jaw for orthodontic treatment plan.
  • Their parents need to read and sign a fully informed form.
  • They shouldn't have any systematic complication or take any medicine during the period of study.
  • The teeth need to be free of any symptom, caries and decalcification
  • They should give a normal response to pulp sensitivity tests (cold test) compared to the control tooth on the same quadrant.
  • The teeth need to be free of mobility or swelling in the surrounding soft tissues and any sensitivity on palpation or percussion.
  • On radiographic examination no apical lucency or PDL widening should be detected.

Exclusion Criteria:

  • tooth crack
  • tooth filling
  • any caries
  • hypocalcification
  • The teeth showing apical lucency
  • PDL widening on radiography
  • sensitivity to cold, heat or bite
  • The responses beyond the normal limits to pulp vitality testing
  • Any medicine consumption

Sites / Locations

  • Azad University, Dental Branch, Tehran, Endodontic department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mineral Trioxide Aggregate

iRoot BP

Arm Description

partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.

Partial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tantalum oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste).

Outcomes

Primary Outcome Measures

dentinal bridge formation
appearance of the dentinal bridge compared to normal dentin will be assessed under microscope

Secondary Outcome Measures

inflammatory status of the pulp
microscopic evaluation : inflammatory cell count and their distribution

Full Information

First Posted
August 19, 2011
Last Updated
March 25, 2012
Sponsor
Islamic Azad University, Tehran
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1. Study Identification

Unique Protocol Identification Number
NCT01420718
Brief Title
Partial Pulpotomy on Caries Free Human Teeth
Official Title
Partial Pulpotomy on Caries Free Human Teeth Using iRootBP and White ProRoot MTA: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the human pulp response to partial pulpotomy using White ProRoot MTA or iRoot BP in the terms of dentinal bridge formation and inflammation.
Detailed Description
This will be a randomized single blind clinical trial. Setting and conduct: Twenty caries free premolar teeth from fifteen patients assigned for orthodontic extraction will be included. Participants including major eligibility criteria: Their parents need to sign an informed form, Patients shouldn't have any systematic complication, The teeth should be free of any symptom, caries and decalcification and should reveal a normal response to pulp sensitivity tests, No mobility or swelling in the surrounding soft tissues, sensitivity on palpation or percussion should be present. Intervention: A class one cavity will be prepared and the depth will be increased until the pulp exposure occurs. One millimeter of the coronal pulp will be removed. Then the exposure site will be covered using two pulpotomy agents: White ProRoot MTA as control group and iRoot BP. After six weeks (42 days) the teeth will be extracted after radiographic and clinical examination to find any sign of swelling, abscess or sinus tract. Main outcome measures (variables): The teeth will be sectioned and examined to compare the presence of dentinal bridge, its thickness and feature in the terms of tunnel defect formation. The underlying pulp will be assessed and graded according to the degree of inflammation as follows: grade 0 no inflammation, grade 1 mild inflammation, grade 2 moderate inflammations, grade 3 severe inflammation, grade 4 abscess formation or necrosis. Our criteria are based on ISO 7405.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Bridge, Pulpitis
Keywords
partial pulpotomy, Cvek pulpotomy, MTA, iRootBP, dentin bridge

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Mineral Trioxide Aggregate
Arm Type
Active Comparator
Arm Description
partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.
Arm Title
iRoot BP
Arm Type
Experimental
Arm Description
Partial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tantalum oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste).
Intervention Type
Drug
Intervention Name(s)
MTA
Other Intervention Name(s)
White ProRoot MTA
Intervention Description
partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.
Intervention Type
Drug
Intervention Name(s)
iRoot BP
Other Intervention Name(s)
Injectable Root Bioaggregate Paste
Intervention Description
Partial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tantalum oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste).
Primary Outcome Measure Information:
Title
dentinal bridge formation
Description
appearance of the dentinal bridge compared to normal dentin will be assessed under microscope
Time Frame
six weeks after intervention
Secondary Outcome Measure Information:
Title
inflammatory status of the pulp
Description
microscopic evaluation : inflammatory cell count and their distribution
Time Frame
six weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who are assigned to extract two premolar teeth in one jaw for orthodontic treatment plan. Their parents need to read and sign a fully informed form. They shouldn't have any systematic complication or take any medicine during the period of study. The teeth need to be free of any symptom, caries and decalcification They should give a normal response to pulp sensitivity tests (cold test) compared to the control tooth on the same quadrant. The teeth need to be free of mobility or swelling in the surrounding soft tissues and any sensitivity on palpation or percussion. On radiographic examination no apical lucency or PDL widening should be detected. Exclusion Criteria: tooth crack tooth filling any caries hypocalcification The teeth showing apical lucency PDL widening on radiography sensitivity to cold, heat or bite The responses beyond the normal limits to pulp vitality testing Any medicine consumption
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahta Fazlyab
Organizational Affiliation
Azad University, Dental Branch, Tehran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azad University, Dental Branch, Tehran, Endodontic department
City
Tehran
ZIP/Postal Code
1946853314
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Partial Pulpotomy on Caries Free Human Teeth

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