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Partial Pulpotomy on Caries Free Human Teeth

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mahta Fazlyab, Islamic Azad University, Tehran
ClinicalTrials.gov Identifier:
NCT01420718
First received: August 19, 2011
Last updated: March 25, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Dentin Bridge
Pulpitis
Drug: MTA
Drug: iRoot BP
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: Partial Pulpotomy on Caries Free Human Teeth Using iRootBP and White ProRoot MTA: a Randomized Controlled Trial

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

Primary Outcome Measures:
  • dentinal bridge formation [ Time Frame: six weeks after intervention ] [ Designated as safety issue: No ]
    appearance of the dentinal bridge compared to normal dentin will be assessed under microscope


Secondary Outcome Measures:
  • inflammatory status of the pulp [ Time Frame: six weeks after intervention ] [ Designated as safety issue: No ]
    microscopic evaluation : inflammatory cell count and their distribution


Enrollment: 24
Study Start Date: June 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mineral Trioxide Aggregate
partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.
Drug: MTA
partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.
Other Name: White ProRoot MTA
Experimental: iRoot BP
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).
Drug: iRoot BP
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).
Other Name: Injectable Root Bioaggregate Paste

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.

  Eligibility

Ages Eligible for Study:   10 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420718

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

No publications provided

Responsible Party: Mahta Fazlyab, post graduate student of Endodontic department, Dental Branch, Islamic Azad University, Tehran
ClinicalTrials.gov Identifier: NCT01420718     History of Changes
Other Study ID Numbers: p/439/d, IRCT201102145804N2
Study First Received: August 19, 2011
Last Updated: March 25, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Islamic Azad University, Tehran:
partial pulpotomy
Cvek pulpotomy
MTA
iRootBP
dentin bridge

ClinicalTrials.gov processed this record on November 25, 2014