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.: PACTR201808614861015 Date of Approval: 31/08/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Reciprocating Single-file and Rotary Instrumentation on the Intensity of Post-operative Pain and Amount of Endotoxins in Primarily Infected Root Canals
Official scientific title Effect of Reciprocating Single-file and Rotary Instrumentation on the Intensity of Post-operative Pain and Amount of Endotoxins in Primarily Infected Root Canals
Brief summary describing the background and objectives of the trial Postoperative pain is one of the primary problems in endodontic treatment. one of the common factors influencing the occurrence of pain after root canal treatment is the extrusion of debris beyond the root apex. It is well known that a small, inadvertent extrusion of debris is common with both manual stainless steel and nickel-titanium rotary instrumentation techniques. However, recent studies have shown that reciprocating instrumentation techniques seem to significantly increase the amount of debris extruded beyond the apex and, consequently, the risk of postoperative pain. in addition, they are claimed of insufficient cleaning of infected root canals as only one file is used to shape the root canal completely from start to finish. So the objective of the trial is to test the null hypothesis which is: in patients with primarily infected root canals whether the reciprocating single-file systems differ from rotary instrumentation in intensity of postoperative pain and level of endotoxins.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 03/07/2018
Actual trial start date 12/07/2018
Anticipated date of last follow up 28/11/2018
Actual Last follow-up date 02/12/2018
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 42
Recruitment status 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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Rotary Instrumentation once one day assess postoperative pain and amount of endotoxins 21 Active-Treatment of Control Group
Experimental Group Reciprocating instrumentation once one day assess postoperative pain and amount of endotoxins 21
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age between 13-73 years old. 2- Males or Females. 3- Permanent mandibular molar teeth with: * Non-vital response of pulp tissue. * Absence of spontaneous pain. * Pain on palpation or tenderness to percussion. * Periapical radiolucency or widening of periodontal membrane space. 1- Patients who have: * Received antibiotic treatment during the last 3 months. * General diseases. 2- Teeth that have: * Periodontal pockets deeper than 4 mm. * Previous endodontic treatment Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 73 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 18/10/2015 research ethics committe
Ethics Committee Address
Street address City Postal code Country
11, Al-Saraya street, Al-Manial Giza 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain 6,12, 24, 48 hours
Secondary Outcome quantification of endotoxins before and after root canal treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of dentistry 11 Al-Saraya street, Al-Manial Giza 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shaimaa Bakry 11, 38 street , Hadayek Helwan Cairo 11731 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Bakry shaimaa30684@gmail.com 00201007417538 11, 38 street, Hadayek Helwan
City Postal code Country Position/Affiliation
Cairo 11731 Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries Geraldine Nasr geraldine.ahmed@dentistry.cu.edu.eg 00201226322227 11 Al-Saraya street, Al-Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Randa Boghdadi r.bogdadi@dentistry.cu.edu.eg 00201001509191 11 Al-Saraya street, Al-Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information