In this randomized double blind clinical trial, 100 individuals with posterior endodontically involved teeth referred to Department of Endodontics of Kerman Dental School, will be divided into two groups after root canal treatment. 50 patients will receive occlusal reduction but; in 50 patients the occlusal contacts will be left intact. Then, the efficacy of the occlusal relief on postoperative pain will be evaluated. Patient’s pain intensity will be recorded and compared between two groups before treatment up to 2 days after operation using Visual Analogue Scale (VAS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806012016N2
Registration date:2010-03-30, 1389/01/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-03-30, 1389/01/10
Registrant information
Name
Masoud Parirokh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1245 7931
Email address
m_parirokh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
The Oral and Dental research Center and Research Committee of Kerman University of Medical Sciences
Expected recruitment start date
2009-09-11, 1388/06/20
Expected recruitment end date
2010-04-09, 1389/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Occlusal Reduction on Pain after Root Canal Treatment
Public title
The Effect of Occlusal Reduction on Pain after Root Canal Preparation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Teeth with occlusal contact, teeth without previous Root canal treatment, Antibiotics or Analgesics consumption,
Exclusion criteria: canals perforated or prepared due to over instrumentation, presence of severe systemic disease, teeth that are abutments of fixed or partial denture, presence of bruxism or clenching, teeth with mobility more than grade one, having less than three teeth in one side of maxillary or mandibular, During the study working length will be determined radiographically by initial file and with apex locator (Root ZX Morita) and in teeth which those measurements aren’t similar the tooth will be excluded.
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethic Committee of Kerman University of Medical Sciences
Street address
Tahmaseb-abad cross- Jahad Street, Vice Resrach Building of kerman University of Medical Sciences,
City
Kerman
Postal code
76174
Approval date
2009-05-18, 1388/02/28
Ethics committee reference number
KA/88-01
Health conditions studied
1
Description of health condition studied
Occlusal reduction
ICD-10 code
k04
ICD-10 code description
Diseases of pulp and periapical tissues
Primary outcomes
1
Description
pain
Timepoint
immediatly before treatmeny
Method of measurement
using visual analouge scale
Secondary outcomes
1
Description
pain
Timepoint
6 hours after treatment up to 2 days
Method of measurement
using visual analouge scale
Intervention groups
1
Description
Occlusal reducton
Category
Prevention
2
Description
without occlusal reduction
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and Dental Research center
Full name of responsible person
Dr.Masoud Parirokh
Street address
Endodontic Department, Kerman Dental School, Shafa Street
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oral and Dental Resreach Center and Vice Chancellor for Research of Kerman University of Medical Sci
Full name of responsible person
Mrs. Hasani
Street address
Tahmasbabad cross, Jahad Street, Vice Chancellor for Research Building,
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oral and Dental Resreach Center and Vice Chancellor for Research of Kerman University of Medical Sci
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 University of Medical Sciences
Full name of responsible person
Nozar Nakhaee
Position
Resrach Manager/ Associate professor
Other areas of specialty/work
Street address
Tahmasbabad cross, Jahad Street, Vice Chancellor for Research Building
City
Kerman
Postal code
Phone
+98 34 1226 3815
Fax
Email
nakhaeen@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masoud Parirokh
Position
Professor
Other areas of specialty/work
Street address
Endodontic Department, Kerman dental School, Shafa street
City
Kerman
Postal code
Phone
+98 34 1245 7931
Fax
Email
M_Parirokh@kmu.ac.ir, masoudparirokh@gmail.com
Web page address
www.kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Rekabi
Position
Postgraduate student
Other areas of specialty/work
Street address
City
Kerman
Postal code
76186
Phone
+98 34 1244 6822
Fax
Email
arekabi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)