The purpose of this study is to evaluate clinical and radiographic success and failure rate of MTA and BMP2 in pulpotomy of primary molars in 12 months follow up. This study is a randomazed single blinde study and is in stage 3 of clinical trial.
In this study 3 to 6 year old children with at least two mandibular primary molars need pulpotomy, is studied. A total of 50 teeth are selected. The criteria for selection of teeth are: exposed vital tooth without signs and symptoms and with no clinical or radiographic evidence of pulp degeneration and the possibility of proper restoration of the tooth.
Teeth with any sign and symptom and clinical or radiographic evidence of pulp degeneration, physiologic mobility and any pathologic root resorption are excluded from the study. The teeth divided into two equal groups. For all teeth caries are removed and coronal access is completed. After coronal pulp amputation, in one group MTA is used as a pulp dressing agent and in the other group BMP2 is used with gel foam. The teeth are restored with Interim Restorative Material (IRM) and then stainless steel crown is placed. Children are recalled for clinical and radiographic evaluation every 3 months for a total follow up period of one year. The case is regarded as a failure when one or more of the following signs are present: internal and external resorption, radiolucency, widening of periodontal ligament, pain, swelling, sensitive to percussion, pathologic mobility or sinus tract.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017062434726N1
Registration date:2017-08-31, 1396/06/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-31, 1396/06/09
Registrant information
Name
Nosrat Nourbakhsh
Name of organization / entity
School of dentistry, Esfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5591
Email address
nourbakhsh@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Dental school, Esfahan University of Medical Sciences; Kowsar Kohangen Company
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of clinical and radiographic success rates of BMP2 and MTA in pulpotomy of primary molars in 3 to 6 year old children
Public title
Effect of BMP2 versus MTA as a medicament in pulpotomy of primary molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Exposed vital tooth without signs and symptoms; Teeth with no clinical or radiographic evidence of pulp degeneration; The possibility of proper restoration of the tooth. Exclusion criteria: Teeth with signs and symptoms; Clinical or radiographic evidence of pulp degeneration; physiologic mobility; Evidence of any pathologial root resorption.
Age
From 3 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The Split mouth design is applied in this study. Base on block randomization table all of the participants will be assigned to receive pulpotomy therapy with MTA in primary mandibular molars of one side and pulpotomy with BMP2 in primary mandibular molars of another side.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Esfahan University of Medical Sciences
Street address
Ethics committe, Dental school, Esfahan University of Medical Sciences, Hezarjerib street, Esfahan
City
Esfahan
Postal code
Approval date
2016-05-27, 1395/03/07
Ethics committee reference number
IR.MUI.REC.1395.3.753
Health conditions studied
1
Description of health condition studied
reversible pulpitis
ICD-10 code
k04.0
ICD-10 code description
reversible pulpitis
Primary outcomes
1
Description
pain
Timepoint
before intervention, 3 months, 6months, 9months and 12 months after intervention
Method of measurement
clinical examination
2
Description
sensitive to percussion
Timepoint
before intervention, 3 months, 6months, 9months and 12 months after intervention
Method of measurement
clinical examination
3
Description
swelling
Timepoint
before intervention, 3 months, 6months, 9months and 12 months after intervention
Method of measurement
clinical examination
4
Description
sinus tract
Timepoint
before intervention, 3 months, 6months, 9months and 12 months after intervention
Method of measurement
clinical examination
5
Description
pathologic mobility
Timepoint
before intervention, 3 months, 6months, 9months and 12 months after intervention
Method of measurement
clinical examination
Secondary outcomes
1
Description
internal resorption
Timepoint
before intervention, 3months, 6months, 9months and 12months after intervention
Method of measurement
radigraphic examination
2
Description
external resorption
Timepoint
before intervention, 3months, 6months, 9months and 12months after intervention
Method of measurement
radigraphic examination
3
Description
PDL widening
Timepoint
before intervention, 3months, 6months, 9months and 12months after intervention
Method of measurement
radigraphic examination
4
Description
radiolucency
Timepoint
before intervention, 3months, 6months, 9months and 12months after intervention
Method of measurement
radigraphic examination
Intervention groups
1
Description
Intervention group: َAfter pulpotomy treatment, 1 microgram recombinant human bone morphogenetic protein 2 (rhBMP2) is placed in pulp chamber.
Category
Treatment - Other
2
Description
group2: After pulpotomy treatment, MTA paste is placed in pulp chamber as a standard pulpotomy medicament.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Department, School of Dentistry,Esfahan University of Medical Sciences
Full name of responsible person
Dr. Nosrat Nourbakhsh
Street address
ُSchool of Dentistry, Esfahan University of Medical Sciences, Hezarjerib street, Esfahan
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Esfahan University of Medical Sciences
Full name of responsible person
Elham Sadat Binande
Street address
Vice chancellor for research, Dental school, Esfahan University of Medical Sciences, Hezarjerib street, Esfahan
City
Esfahan
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, Esfahan University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Kowsar Kohan Gen company
Full name of responsible person
Amir Hossein Behnia
Street address
Flat. A13, Ghadir street
City
Sepahanshahr
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kowsar Kohan Gen company
Proportion provided by this source
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Sanaz Ziaei
Position
Resident of pediatric dentistry
Other areas of specialty/work
Street address
Pediatric Department, Dental school, Esfahan University of Medical Sciences, Hezarjerib street
City
Esfahan
Postal code
Phone
+98 31 3792 5591
Fax
Email
sanaz20_2005@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Sanaz Ziaei
Position
Resinet of pediatric dentistry
Other areas of specialty/work
Street address
Pediatric Department, Dental school, Esfahan University of Medical Sciences, Hezarjerib street
City
Esfahan
Postal code
Phone
+98 31 3792 5591
Fax
Email
sanaz20_2005@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Sanaz Ziaei
Position
Resident of pediatric dentistry
Other areas of specialty/work
Street address
Pediatric Department, Dental school, Esfahan University of Medical Sciences, Hezarjerib street
City
Esfahan
Postal code
Phone
+98 31 3792 5591
Fax
Email
nourbakhsh@dnt.mui.ac.ir; sanaz20_2005@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)