Objective: This clinical trial study to compare the pain is primary pulpectomies vital teeth in one session (pulpectomy and paste coated steel) and two sessions (treatment Endodontic treatment in a meeting and put the cover in the next session) is performed.
Materials and Methods: In this study, 100 primary molars in children 12-6 years of age are enrolled. Each child with milk teeth need treatment pulpectomies in this study is vital. Treatment of a meeting like this; after caries removal and cavity preparation, root access with Barbad Broach out the pulp tissue, dental Canal after controlling bleeding dry channels, ZOE diluted mixture is then used to fill channels stainless steel is coated dental restoration. Two sessions of treatment consists of two stages in the first session and the second session of the pulp treatment is plated stainless steel.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122231473N1
Registration date:2017-02-05, 1395/11/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-05, 1395/11/17
Registrant information
Name
Elham Farokhgisor
Name of organization / entity
Faculty of dentistry, Kerman
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 9021
Email address
e_farokh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2016-12-10, 1395/09/20
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of post-operative pain following pulpectomy of vital deciduous teeth in one or two sessions: a randomized clinical trial
Public title
Comparison of pain in root canal therapy of primary teeth in one or two visit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: vital decidious teeth with active bleeding during access cavity preparation, lack of clinical and radiographic evidence of pulpal necrosis, resorption of less than two third of the root length, restoration possible, cooperative child, at least one molar with evidence of irreversible pulpitis , e.g. sensitivity to cold or hot stimulus.
Exclusion criteria: child with systemic diseases, follicular or dentigerous cyst below decidous tooth, pathologic resorption of at least one third of root length with fistulous sinus tract, resorption of more than two third of root length, isolation of tooth not possible, advanced internal resorption, periradicular lucency involving permanent tooth bud.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Research and Technology, Kerman University of Medical Sciences
Street address
Tahmasebabad Crossroads, Building Department, Research and Technology
City
Kerman
Postal code
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.KMU.REC.1394.624
Health conditions studied
1
Description of health condition studied
Pulp therapy in primary
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Pain relief after visit
Timepoint
one day-seven days
Method of measurement
VAS
Secondary outcomes
1
Description
Pain relief
Timepoint
1-7 day
Method of measurement
VAS
Intervention groups
1
Description
Control group:Pulpectomy treatment and insert the SSC in one visit
Category
Other
2
Description
Intervention group: Pulpectomy treatment in one session and the second session insert the SSC.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of dentistry, Kerman
Full name of responsible person
Dr Masoumeh Aminizadeh
Street address
Shafa Street, Faculty of dentistry
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Vice Chancellry, Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhti
Street address
Tahmasebabad Crossroads, Building Department of Science and Technology of Kerman University of Medical Sciences
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Vice Chancellry, Kerman University of Medical Sciences
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
Kerman Univesity of Medical Sciences -School of Dentistry
Full name of responsible person
Dr Masoumeh Aminizadeh
Position
resident of pediatric dentistry
Other areas of specialty/work
Street address
Pediatric Dentistry Department, School of Dentistry, Shafa Street, Jomhori Islami Blvd, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 1211 9021
Fax
Email
Aminizadeh66@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences-School of Dentistry
Full name of responsible person
Dr Massoud Parrirokh
Position
Full Proffessor Endodontist
Other areas of specialty/work
Street address
Pediatric Dentistry Department, School of Dentistry, Shafa Street, Jomhori Islami Blvd, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 3211 9021
Fax
00
Email
masoudparirokh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of dentistry, Kerman
Full name of responsible person
Elham farokhgisor
Position
ssociate Professor, Department of Pediatric Dentistry
Other areas of specialty/work
Street address
Shafa Street, Faculty of dentistry
City
Kerman
Postal code
Phone
+98 34 3211 9021
Fax
00
Email
e_farokh@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)