Objectives: The aim 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.
Design: This will be a randomized single blind clinical trial.
Setting and conduct: Thirty 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102145804N2
Registration date:2011-08-12, 1390/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-12, 1390/05/21
Registrant information
Name
Mahta Fazlyab
Name of organization / entity
Islamic Azad University, Dental Branch, Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
mfazlyab@dentiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Dr. Arash Azizi, Vice chancellor for research, Islamic Azad University, Dental Branch, Tehran
Expected recruitment start date
2011-06-20, 1390/03/30
Expected recruitment end date
2012-02-28, 1390/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Partial pulpotomy on caries free human teeth using iRootBP and White ProRoot MTA: a randomized controlled trial
Public title
Partial pulpotomy on caries free human teeth using iRootBP and White ProRoot MTA: a randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who are assigned to extract two premolar teeth in one jaw for orthodontic treatment plan will be included; 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: Any sign of crack; filling; caries or hypocalcification on teeth will cause exclusion. Also the teeth showing apical lucency or PDL widening will be excluded; Any sensitivity to cold, heat or bite will lead to exclusion; The responses beyond the normal limits to pulp vitality testing and any medicine consumption would cause exclusion.
Age
From 10 years old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Islamic Azad University, Dental Branch, Tehran
Street address
No 4, 10th neyestan, Pasdaran street,Tehran,Iran
City
Tehran
Postal code
1946853314
Approval date
2011-06-16, 1390/03/26
Ethics committee reference number
د/439/پ
Health conditions studied
1
Description of health condition studied
pulp inflammation
ICD-10 code
K04.1
ICD-10 code description
Necrosis of pulp
Primary outcomes
1
Description
dentinal bridge formation
Timepoint
six weeks after intervention
Method of measurement
microscopic evaluation
2
Description
appearance of the dentinal bridge compared to normal dentin
Timepoint
six weeks after intervention
Method of measurement
microscopic evaluation of appereance of the dentinal bridge compared to normal dentin
3
Description
thickness of the dentinal bridge compared to normal dentin
Timepoint
six weeks after intervention
Method of measurement
microscopic evaluation of thickness of the dentinal bridge compared to normal dentin
Secondary outcomes
1
Description
inflammatory status of the pulp
Timepoint
six weeks after intervention
Method of measurement
microscopic evaluation : inflammatory cell count and their distribution
Intervention groups
1
Description
Intervention group: 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 Tanthalium oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste).
Category
Treatment - Drugs
2
Description
control group: partial pulpotomy using White ProRoot MTA.
Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, Dental Branch, Tehran, Endodontic department
Full name of responsible person
Mahta Fazlyab
Street address
number 4, 10th Neyestan, Pasdaran st
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Islamic Azad University, Dental Branch, Tehran
Full name of responsible person
Dr. Arash Azizi
Street address
number 4, 10th Neyestan, Pasdaran st
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Islamic Azad University, Dental Branch, Tehran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University, Dental Branch, Tehran
Full name of responsible person
Mahta Fazlyab
Position
post graduate student of endodontic department
Other areas of specialty/work
Street address
number 4, 10th Neyestan, Pasdaran st
City
Tehran
Postal code
1946853314
Phone
+98 21 2275 2019
Fax
+98 21 2205 5386
Email
Dr.mfazlyab@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Dental Branch, Tehran
Full name of responsible person
Mahta Fazlyab
Position
post graduate student of endodontic department
Other areas of specialty/work
Street address
number 4, 10th Neyestan, Pasdaran st
City
Tehran
Postal code
1946853314
Phone
+98 21 2275 2019
Fax
+98 21 2205 5386
Email
dr.mfazlyab@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Dental Branch, Tehran
Full name of responsible person
Mahta Fazlyab
Position
post graduate student of endodontic department
Other areas of specialty/work
Street address
number 4, 10th Neyestan, Pasdaran st, Tehran, Iran
City
Tehran
Postal code
1946853314
Phone
+98 21 2275 2019
Fax
+98 21 2205 5386
Email
dr.mfazlyab@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)