The purpose of this in-vivo study is comparison of different methods of root canal obturation in primary molars with digital radiography. This study is randomize and single blind . 60
primary mandibular molars from healthy cooperating children(4-7 years) who have first or second molars indicated for pulpectomy will be selected. In each tooth 2 canals will be assessed. After obtaining consent from their parents or guardians , the teeth will be treated under local anesthesia and randomly divided into 5 groups. The root canals in each group will be filled with Zinc oxide-eugenol paste. The paste will be transported into the canals using one of the randomly assigned methods:
1-local anesthetic syringe
2-Insulin syringe
3-NaviTip system
4-Condensing with plugger
5-lentulo spiral
The access cavity will be filled with IRM and the crown will be restored with S.S.C . Post-operative digital radiographs will be taken.
All assessments will be performed by two operator who are blind to the treatment groups. The radiographs will be analyzed to assess presence of voids , number and size of voids , and canal obturation quality.
The quality of canal obturation is based on the amount of paste in the canal.
If less than one-half of the canal filled, the score is 1.
If greater than one-half but less than two-third filled, the score is 2.
Optimal filling (0-1.5 mm shorter than the apex) is score 3.
Over filling belongs to score 4.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031012773N1
Registration date:2013-04-29, 1392/02/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-29, 1392/02/09
Registrant information
Name
Zeinab Bouzarjomehri
Name of organization / entity
Ddental college of Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 79 22891
Email address
bozarjomehri.z@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of dental college of Isfahan University of Medical Sciences
Expected recruitment start date
2013-05-05, 1392/02/15
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radiographic Evaluation Of Pulpectomies In Primary Molars Using Five Filling Systems: An in-vivo study
Public title
Evaluation of different methods of root canal treatment in primary dentition
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: healthy children who have first or second molars indicated for pulpectomy according to the following 1- spontaneous pain 2-continuous bleeding after amputation of coronal pulp or pus discharge from the canal 4- tenderness to percussion or palpation 5-redness and swelling of the vestibule.
Exclusion criteria :systemic disease- uncooperative child- unrestorable tooth-chronic abscess- internal,external and physiologic root resorption
Age
From 4 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Vice chancellor for research of Dental College of Isfahan university of Medical Sciences
Street address
Dental College, Isfahan University of Medical Sciences, Azadi square(Darvazeh Shiraz), Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
391274
Health conditions studied
1
Description of health condition studied
Disease of pulp and periapical tissue
ICD-10 code
k04.0
ICD-10 code description
pulpitis
Primary outcomes
1
Description
level of canal obturation
Timepoint
after intervention and taking radiograph
Method of measurement
from radiograph in term of grade(1 to 4)
Secondary outcomes
1
Description
number and size of voids
Timepoint
after intervention and taking radiograph
Method of measurement
number in term of numeral_size in term of square millimeter
Intervention groups
1
Description
Endodontic treatment in order to
Remove the infection from the root canal in all experimental groups
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental College of Isfahan University of Medical Sciences
Full name of responsible person
Doctor Nosrat Nourbakhsh-Pediatric Dentist-Assisstant professor