Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201511001335246 Date of Approval: 02/11/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of Postoperative Pain after Working Length determination Using Electronic Apex Locator versus Digital Radiography in Multirooted Teeth
Official scientific title Evaluation of Postoperative Pain after Working Length determination Using Electronic Apex Locator versus Digital Radiography in Multirooted Teeth A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial postoperative pain is one of the primary problems in endodontic treatment and fear of pain is one of the major reasons for dental apprehension and is very annoying to the patient. There are several factors associated with postoperative pain that may be overlooked by the dentist such as the position of the apical foramen as a result of incorrect working length determination causing under or over instrumentation with possibility of apical tissue injury. So failure to accurately determine the length of the tooth may lead to either incomplete cleaning and apical leakage or apical perforation and overfilling with increased incidence of postoperative pain. Accurate working length determination helps to decide the extent to which the instruments are placed and worked in the root canal system and this will determine how effectively the unwanted items are removed from it. This will also limit the depth to which the canal filling may be placed. Correct working length determination will also affect the degree of pain and discomfort that the patient would feel following the appointment. Thus it plays an important role in determining the success of the treatment. A debate is present on which is more accurate in identifying the correct working length with subsequent reduction in postoperative pain and discomfort whether it is a digital radiograph or an apex locator. The purpose of this study is to evaluate the effect of working length determination by electronic apex locator or digital radiography on postoperative pain and to evaluate the number of days needed for this pain to dissappear and the number of analgesic tablets the patient may consume.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,postoperative pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/12/2015
Actual trial start date 01/12/2015
Anticipated date of last follow up 01/12/2016
Actual Last follow-up date 01/12/2016
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants) 54
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised A random sequence will be generated by computer software In the Center of Evidence Based Dentistry, CairoUniversity. Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group apex locator once determining working length using apex locator 27
Control Group digital radiograph once determining working length using a digital radiograph 27
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with irreversible pulpitis patients with vital pulp multirooted teeth permanent teeth patients with non vital pulp single rooted teeth deciduous teeth 12 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/07/2015 ethics commitee of faculty of oral and dental medicine, cairo university
Ethics Committee Address
Street address City Postal code Country
11 el saraya street cairo 11936 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post operative pain 4 hours 6 hours 12 hours 24 hours 48 hours
Secondary Outcome number of days taken by postoperative pain to dissappear 7 days
Secondary Outcome number of analgesic tablets consumed by the patient 7 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of oral and dental medicine, cairo university 11 el saraya street cairo 11936 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 5/3 elaselky street, new maadi cairo 11435 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of oral and dental medicine, cairo university 11 el saraya street cairo 11936 Egypt University
COLLABORATORS
Name Street address City Postal code Country
saeed abdelaziz 11 el saraya street cairo 11936 Egypt
geraldine ahmed 11 el saraya street cairo 11936 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator fatma mohamed fatma.abunaeem@dentistry.cu.edu.eg 01001324224 5/3 elaselky street, maadi
City Postal code Country Position/Affiliation
cairo 11435 Egypt assisstant lecturer
Role Name Email Phone Street address
Public Enquiries fatma mohamed fatma.abunaeem@dentistry.cu.edu.eg 01001324224 5/3 elaselky street, maadi
City Postal code Country Position/Affiliation
cairo 11435 Egypt assisstant lecturer
Role Name Email Phone Street address
Scientific Enquiries fatma mohamed fatma.abunaeem@dentistry.cu.edu.eg 01001324224 5/3 elaselky street, maadi
City Postal code Country Position/Affiliation
cairo 11435 Egypt assisstant lecturer
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information