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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 19, 2011

Last Updated Date

March 25, 2012

Start Date ^ICMJE

June 2011

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01420718 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

inflammatory status of the pulp [ Time Frame: six weeks after intervention ] [ Designated as safety issue: No ]

microscopic evaluation : inflammatory cell count and their distribution

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Partial Pulpotomy on Caries Free Human Teeth

Official Title ^ICMJE

Partial Pulpotomy on Caries Free Human Teeth Using iRootBP and White ProRoot MTA: a Randomized Controlled Trial

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Dentin Bridge
Pulpitis

Intervention ^ICMJE

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
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

Study Arm (s)

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.

Intervention: Drug: 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).

Intervention: Drug: iRoot BP

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2012

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

10 Years to 14 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01420718

Other Study ID Numbers ^ICMJE

p/439/d, IRCT201102145804N2

Has Data Monitoring Committee

Responsible Party

Mahta Fazlyab, Islamic Azad University, Tehran

Study Sponsor ^ICMJE

Islamic Azad University, Tehran

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mahta Fazlyab

Azad University, Dental Branch, Tehran

Information Provided By

Islamic Azad University, Tehran

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top