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.: PACTR201402000685621 Date of Approval: 22/10/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of irrigating solutions on post operative pain and intensity of bacteremia following single visit root canal treatment
Official scientific title The effect of irrigating solutions on post operative pain and intensity of bacteremia following single visit root canal treatment.
Brief summary describing the background and objectives of the trial Does MTAD as a final irrigant result in decreased intensity of postoperative pain, reduction of bacteria from the root canal system together with reduction of intensity of bacteremia when compared to Sodium hypochlorite used alone following single visit root canal treatment of non vital teeth ?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 22/09/2013
Actual trial start date 20/10/2013
Anticipated date of last follow up 31/10/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 using a randomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MTAD as a final irrigant 3 milliliter of the irrigant MTAD for 5 minutes at the end of chemomechanical preparation irrigating solution 20
Control Group Saline 3 milliliter of the irrigant 5 minutes irrigant 20
Experimental Group Sodium hypochlorite 3 milliliter of the irrigant 5 minutes irrigating solution 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- patients with no relevant comorbid conditions 2- permenant teeth with non vital pulps 3- no antibiotics,anti-inflammatory or analgesics at least 30 days before the study treatment 4- clinical study 5- one visit root canal treatment using MTAD or NaOCl as an irrigating solution 6- initial root canal treatment 7-permenant single rooted teeth with fully formed apices 8- patients having a diagnosis of pulpal necrosis with or without apical periodontitis 1- primary teeth 2- teeth with vital pulps 3- periapical abscess 4- previous endodontic treatment 5- invitro study 6- patients with calcified teeth, deep periodontal pockets,persistant exudates or incomplete root formation 17 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 15/10/2013 Ethics committee of scientific research- Faculty of oral and dental medicine-Cairo University
Ethics Committee Address
Street address City Postal code Country
El-Kasr El Einy street Cairo 002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain(binary) using a modified visual analogue scale -6 hours after appointment -12 hours -18 hours -24 hours -2 days -3 days -4 days -5 days -6 days -7 days
Secondary Outcome intracanal bacterial culture - immediately after access cavity preparation - immediately after terminating chemomechanical preparation.
Secondary Outcome intensity of bacteremia - Immediately before starting access cavity preparation - Immediately after terminating chemomechanical preparation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Patients will be selected from the outpatient clinic of Endodontics department-Cairo University EL-Kasr El Einy street Cairo 002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National research institute El- Bohooth street, aldokki square Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National research institute El- Bohooth street, aldokki square Cairo Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
National research institute El- Bohooth street, aldokki square Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jealan El- Shafei dr_jealan@yahoo.com 01005839012
City Postal code Country Position/Affiliation
Giza Egypt professor of Endo department-Cairo University.
Role Name Email Phone Street address
Public Enquiries Jeraldin Ahmed eyadelbatawi@hotmail.com 01226322227
City Postal code Country Position/Affiliation
cairo Egypt Lecturer of endodontics department-Cairo University
Role Name Email Phone Street address
Scientific Enquiries Nayra Mehanna eyadelbatawi@hotmail.com 01116555576
City Postal code Country Position/Affiliation
cairo Egypt Professor of microbiology - National Research Institute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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