The purpose of this study was to compare the clinical effectiveness of periodontal ligament injection versus block for pulpotomy of mandibular primary molars. The healthy and cooperative children who required pulpotomy entered to this study. 80 children aged 3-7 years old who required pulpotomy in symmetrical mandibular primary molars were selected.These children's teeth were anesthetized with periodontal injection on one side of mandible and block on the other side. Pulpotomy were performed on each patient during the same appointment. Signs of discomfort included hand , body tension and eye movement indicating pain, verbal complaint and crying(SEM scale ) , were evaluated blindly by a dental assistant who was not informed about above groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205279882N1
Registration date:2012-08-17, 1391/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-17, 1391/05/27
Registrant information
Name
Roza Haghgoo
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 6227
Email address
haghgou@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center, Dental School, Shahed University
Expected recruitment start date
2009-09-11, 1388/06/20
Expected recruitment end date
2009-12-11, 1388/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of periodontal ligament injection and inferior alveolar nerve block in mandibular primary molars pulpotomy: A randomized control trial
Public title
Effect of periodontal ligament injection in anesthetizing of in mandibular primary molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: children who required pulpotomy on symmetrical mandibular primary molars; were healthy ;did not have any contra indication for local anesthesia; were cooperative.
Exclusion Criteria: children were not healthy ; had contra indication for local anesthesia ; were not cooperative.
Age
From 3 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee , Shahed University
Street address
N 72, Italia Str, Vesal Ave
City
Tehran
Postal code
Approval date
2009-08-10, 1388/05/19
Ethics committee reference number
2174/1388
Health conditions studied
1
Description of health condition studied
patient's pain during dental anesthesia
ICD-10 code
K08.9
ICD-10 code description
Disorder of teeth and supporting structures, unspecified
Primary outcomes
1
Description
anesthetizing
Timepoint
during the treatment
Method of measurement
Signs of discomfort included hand , body tension and eye movement indicating pain, verbal complaint and crying
Secondary outcomes
empty
Intervention groups
1
Description
In experimental group( periodontal ligament injection)0.5ml lidocain Hcl2% was injected in the bottom of the middle part of buccal gingival sulcus
Category
Treatment - Drugs
2
Description
In control group(Block injection) 1.3ml lidocain Hcl2% was injected near inferior alveolar nerve and 0.5 ml was injected in the bottom of sulcus
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dept of Pediatric Dentistry,Dental School, Shahed University
Full name of responsible person
Vafanoush
Street address
N71, Italia Str, Vesal Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Center, Dental School, Shahed University
Full name of responsible person
Rezvani
Street address
N71, Italia Str, Vesal Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center, Dental School, 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
Research Center, Dental School, Shahed University
Full name of responsible person
Vafanoush
Position
Masters
Other areas of specialty/work
Street address
N71, Italia Str, Vesal Ave
City
Tehran
Postal code
Phone
+98 21 8895 6227
Fax
Email
mvafanoush@yahoo.co
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Center, Dental School, Shahed University
Full name of responsible person
Rezvani
Position
Assistant Professor
Other areas of specialty/work
Street address
N71, Italia Str, Vesal Ave
City
Tehran
Postal code
Phone
+98 21 8895 6227
Fax
Email
mbrezvani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Researc Center, Dental School, Shahed University
Full name of responsible person
Vafanoush
Position
Master
Other areas of specialty/work
Street address
N71- Italia Str- Vesal Ave
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)