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.: PACTR201804003323280 Date of Approval: 11/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Treatment outcome of manual versus rotary techniques in single-visit endodontics for patients in a Nigerian Teaching Hospital
Official scientific title A comparative study of the treatment outcome of protaper rotary and manual step-back root canal preparation techniques in single visit endodontic therapy for patients at the Lagos University Teaching Hospital
Brief summary describing the background and objectives of the trial Background: Canal preparation is the most significant step for a successful root canal treatment. Canal preparation techniques have evolved over time and the several advancements in Nickel-titanium (NiTi) rotary systems have assisted endodontists in performing root canal treatment in a single visit. NiTi rotary instruments have steadily gained grounds in the field of endodontics, however, they are at the introductory stage in Nigeria. Several studies have focussed on debris extrusion and post-operative pain when comparing the manual and rotary techniques, but there is paucity of reports when comparing the success/treatment outcomes. Objectives: This study was conducted to compare the treatment outcomes of single-visit root canal treatment when either manual step-back or rotary technique is used to prepare the canals, employing clinical and radiographic criteria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Irreversible pulpitis, Pulp necrosis, Apical periodontitis,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 07/04/2014
Actual trial start date 05/05/2014
Anticipated date of last follow up 11/05/2015
Actual Last follow-up date 06/07/2015
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
ADM/DCST/HREC/1684 Lagos University Teaching Hospital Health Reseach and Ethics Committee (NHREC: 19/12/2008a)
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 randomisation using by using procedures such as coin-tossing or dice-rolling 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 Rotary group Single treatment Less than 2 hours Modern approach to root canal preparation- rotary technique 60 Active-Treatment of Control Group
Control Group Manual group Single Less than 2.5 hours Conventional approach of root canal preparation: step-back technique 60 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Teeth with no pain to moderate pain Irreversible pulpitis Apical periodontitis not exceeding 2x2mm periapical radiolucency Necrotic teeth with/without apical lesion associated with a non-discharging sinus Teeth with weeping canals Acute abscess Excessively curved roots Unrestorable teeth 18 Year(s) 65 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 03/02/2014 Lagos University Teaching Hospital(LUTH) Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Idi-Araba Lagos 23 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of pain, swelling, mobility, tenderness to percussion, sinus tract and function of the treated tooth) and radiographic parameters (size of periapical radiolucency) 1 day 1 week 1 month 3 months 6 months
Secondary Outcome Incidence of pain, swelling, mobility, tenderness to percussion, sinus tract and function of the treated tooth) and radiographic parameters (size of periapical radiolucency) 1 day 1 week 1 month 3 months 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Idi-Araba Lagos 234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self-funded Idi-Araba Lagos 234 Nigeria
Parents- Dr. and Prof. (Mrs.) B.O. Makanjuola 13, Alvan Ikoku Crescent, University of Lagos Lagos 234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Parents- Dr. and Prof. (Mrs.) B.O. Makanjuola 13, Alvan Ikoku Crescent, University of Lagos Lagos 234 Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr. D.C. Umesi Idi-Araba Lagos 234 Nigeria
Dr. O.H. Oderinu Idi-Araba Lagos 234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator John Makanjuola jtmaks84@yahoo.ccom 234-8034096722 Idi-Araba
City Postal code Country Position/Affiliation
Lagos 234 Nigeria Lecturer I/ College of Medicine, University of Lagos
Role Name Email Phone Street address
Public Enquiries Donna Umesi ukchioma@yahoo.com 234-8023021700 Idi-Araba
City Postal code Country Position/Affiliation
Lagos 234 Nigeria Associate Professor & Consultant College of Medicine, University of Lagos
Role Name Email Phone Street address
Scientific Enquiries Olabisi Oderinu bisioderinu@yahoo.co.uk 234-8023077654 Idi-Araba
City Postal code Country Position/Affiliation
Lagos 234 Nigeria Senior Lecturer & Consultant/ College of Medicine, University of Lagos
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