Abstract Objectives: The aim of this study was to evaluate pulpal response of primary teeth after direct pulp capping with two biocompatible materials, Mineral Trioxide Aggregate (MTA) and Bio Active Glass (BAG) Design: This study will perform as double blind randomized clinical trial on 22 healthy primary canines which will be extracted for orthodontic reasons. Setting and conduct: The teeth will randomly divide into two groups by using a random-numbers table each with 11 teeth and will treat with direct pulp capping. Major Inclusion and Exclusion criteria: sound primary canines in children 7 to 8 years old that require extraction for orthodontic treatment; No more than one-third of the root resorption. Intervention: the exposure sites will randomly cap with MTA or BAG in the two groups. Main outcome measures: After 2 months the teeth will be extracted and will be evaluated the inflammation, dentine bridge formation, internal resorption and abscess histologically.
General information
Acronym
MTA,BAG
IRCT registration information
IRCT registration number:IRCT2015100624397N1
Registration date:2015-11-23, 1394/09/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-23, 1394/09/02
Registrant information
Name
Motahare Ahmadvand
Name of organization / entity
Shahed university, Dental school,department of pediatric dentistry
Country
Iran (Islamic Republic of)
Phone
+98 21 8837 8039
Email address
m.ahmadvand@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2011-09-25, 1390/07/03
Expected recruitment end date
2012-01-20, 1390/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of pulpal response of primary teeth after direct pulp capping with Bioactive Glass and Mineral Trioxide Aggregate
Public title
Clinical trial comparing the effects of Bioactive Glass and Mineral Trioxide Aggregate on pulpal response in children 7 to 8 years old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: sound primary canines in children 7 to 8 years old that require extraction for orthodontic treatment.
Exclusion criteria: primary canines that have root resorption more than the apical third.
Age
From 7 years old to 8 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization by random-numbers table
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed university,dental school
Street address
Number 39, Italy St, Vesal St, Enghelab St
City
Tehran
Postal code
1417755351
Approval date
2011-05-14, 1390/02/24
Ethics committee reference number
40/104951
Health conditions studied
1
Description of health condition studied
direct pulp cap
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
inflammation
Timepoint
2 months after intervention
Method of measurement
Histologically
2
Description
dentinal bridge formation
Timepoint
2 months after intervention
Method of measurement
Histologically
3
Description
internal resorption
Timepoint
2 months after intervention
Method of measurement
Histologically
4
Description
abscess
Timepoint
2 months after intervention
Method of measurement
Histologically
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Control group: none
Category
Treatment - Other
2
Description
Intervention group1:
Direct pulp capping in exposure site with MTA (Angelus, Brazil)
Category
Treatment - Other
3
Description
Intervention group 2:
Direct pulp capping in exposure site with BAG (3iImplant Innovations, USA)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahed university, faculty of dentistry
Full name of responsible person
Karami
Street address
Number 39, Italy St, Vesal St, Enghelab St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of dental school of Shahed university
Full name of responsible person
Gharaje
Street address
Number 39, Italy St, Vesal St, Enghelab 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 dental school of Shahed university
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
Shahed university, Faculty of dentistry
Full name of responsible person
Roza Haghgoo
Position
pedodontist/Professor, Dept of Pediatric Dentistry, Dental School, Shahed University
Other areas of specialty/work
Street address
Number 39, Italy St, Vesal St, Enghelab St
City
Tehran
Postal code
1417755351
Phone
+98 21 8895 9210
Fax
+98 21 8896 7618
Email
haghgoodent@yahoo.com
Web page address
Shahed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University, Dental school
Full name of responsible person
Roza Haghgoo
Position
Pedodontist
Other areas of specialty/work
Street address
Number 39, Italy St, Vesal St, Enghelab St
City
Tehran
Postal code
1417755351
Phone
+98 21 8895 9210
Fax
+98 21 8896 7618
Email
haghgoodent@yahoo.com
Web page address
Shahed.ad.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahed University, Dental school
Full name of responsible person
Motahare Ahadvand
Position
Resident, Dept of Pediatric Dentistry
Other areas of specialty/work
Street address
Number 39, Italy St, Vesal St, Enghelab St
City
Tehran
Postal code
1417755351
Phone
+98 21 8837 8039
Fax
+98 21 8896 7618
Email
motahare.ahmadvand@yahoo.com
Web page address
Shahed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)