Protocol summary

Summary
The aim of this study is to compare the adequacy of working length in root canal therapies in which length determination is done by one of these two methods; radiographic or electronic measurement. Inclusion criteria are need for Endodontic treatment and age of 20-65 years. Exclusion criteria are open apexes and blocked canals. Sample size is 280 canals from all types of tooth selected from all patients admitting to endodontic speciality clinic. Patients will be randomly allocated to group A, in which length determination will be done by Root ZX electronic apex locator, and group B, in which length determination will be done by conventional radiography. The primary outcome is adequacy of length which will be assessed after completing treatment by two endodontists blinded to group allocation by evaluating final and master cone radiographies. Adequacy of length is graded by this classification: short (tip of gutta is shorter than 2mm from the apex), adequate (between 0-2 mm of the apex), and over (obturation material is extended over the apex).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138803121991N1
Registration date: 2009-06-30, 1388/04/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2009-06-30, 1388/04/09
Registrant information
Name
Seyed Javad Anvar
Name of organization / entity
Shiraz University of Medical Sciences- Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 3193
Email address
anvarj@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz Univesity of Medical Sciences
Expected recruitment start date
2009-06-10, 1388/03/20
Expected recruitment end date
2009-07-11, 1388/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Evaluation of Working Length Determination by Electronic Apex-Locator or Radiography on Adequacy of Final Working Length
Public title
Clinical Evaluation of Working Length Determination by Electronic Apex-Locator or Radiography on Adequacy of Final Working Length
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: All the patients who are referred for Root Canal Therapy Exclusion Criteria: Blocked Canals, Open Apexes
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 172
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

1

Registry name
ClinicalTrials.gov
Secondary trial Id
NCT00901810
Registration date
2009-05-12, 1388/02/22

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences, Research Affairs Management
Street address
Zand Ave.
City
Shiraz
Postal code
Approval date
1388-03-15, 769/01/-734
Ethics committee reference number
4492

Health conditions studied

1

Description of health condition studied
Root Canal Therapy
ICD-10 code
K04
ICD-10 code description
Diseases of pulp and periapical tissues

Primary outcomes

1

Description
Adequacy of final working length
Timepoint
Only one time after finishing Root Canal Therapy
Method of measurement
Evaulation of length adequacy of Master Cone Radiography

Secondary outcomes

1

Description
Length adequacy of Obturation
Timepoint
Once after finishing Obturation
Method of measurement
Evaluation of length adequacy in final radiography

Intervention groups

1

Description
3rd generation Apex locator in the intervention group
Category
Diagnosis

2

Description
radiographic length measurement in control group
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Dental School
Full name of responsible person
Street address
City

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Dr. Shohre Ravanshad
Street address
Ghasrodasht ave.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz Dental School
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
Shiraz Dental School
Full name of responsible person
Shohre Ravanshad
Position
Associate professor, Endodontics Department
Other areas of specialty/work
Street address
Ghasrodasht
City
Shiraz
Postal code
Phone
+98 71 1626 3193
Fax
Email
sravanshad@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Alireza Adl
Position
Assistant professor, Endodontics Department
Other areas of specialty/work
Street address
Ghasrodasht ave.
City
Shiraz
Postal code
Phone
+98 71 1626 3193
Fax
Email
adla@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Seyed Javad Anvar
Position
Resident of Endodontics
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
anvarj@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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