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.: PACTR201805003296247 Date of Approval: 05/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Posterior root canal treatment outcome and antibacterial efficacy using conventional irrigation versus combined with passive ultrasonic irrigation
Official scientific title Posterior root canal treatment outcome and antibacterial efficacy employing conventional irrigation alone versus combined with passive ultrasonic irrigation
Brief summary describing the background and objectives of the trial The objectives of this trial are to compare the reduction in bacteria counts, the clinical signs and symptoms, and the radiographic changes between passive ultrasonic irrigation combined with conventional syringe irrigation and conventional syringe irrigation alone during root canal treatment in posterior teeth.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Irreversible pulpitis, apical periodontitis,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 03/05/2017
Actual trial start date 03/05/2017
Anticipated date of last follow up 05/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Closed to recruitment,follow-up continuing
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 randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Passive ultrasonic irrigation This is used in the final phase of chemomechanical preparation of the root canals in the tooth. It is used for one minute in each root canal in the tooth Passive ultrasonic irrigation is used for one minute in each root canal at the end of the chemomechanical preparation of the canals during which conventional syringe irrigation had been used 30
Control Group Conventional syringe irrigation This is used in the final phase of chemomechanical preparation of the root canals in the tooth. It is used for one minute in each root canal in the tooth. Conventional syringe iirrigation is used for one minute in each root canal at the end of the chemomechanical preparation of the canals during which this same type of irrigation had been used. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Posterior teeth except the third molars requiring root canal treatment due to irreversible pulpitis, pulp necrosis, traumatic pulpal exposure. Teeth with apical periodontitis with none or minimal (0-2mm) periapical radiolucency. Presence of none or mild to moderate pain. Permanent teeth with closed apex. Presence of favorable tooth morphology (absence of pulp stones and sclerosis, excessive root curvature). Restorable tooth following root canal treatment. Teeth which are deemed unrestorable. Teeth which have had previous endodontic treatment. Teeth with open apices. Acute apical periodontitis with severe pain on percussion. Teeth with apical lesion that are asymptomatic and no sinus tract. Symptomatic non-vital teeth with periapical radiolucency and no sinus tract. Presence of cysts. Patients with temporomandibular joint disorders. Teeth with unfavorable morphology. Teeth with internal or external root resorption. Patients with debilitating medical conditions. Periodontally compromised teeth. Teeth requiring surgical endodontics. Patients with acute apical abscess that would require incision and drainage. Presence of weeping canal(s) that cannot be dried. Patients who have received antibiotic therapy within the last three months. Uncooperative, poorly motivated, and patients not interested in being part of the research. 18 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 16/08/2016 Lagos University Teaching Hospital Health Research Ethics Committee.
Ethics Committee Address
Street address City Postal code Country
Ishaga road Idi-Araba, Lagos state 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The comparison of the reduction in bacterial colony forming units between the experimental and control groups. After the samples taken during treatment have been assessed in the microbiology laboratory.
Secondary Outcome Comparison of the incidence of pain, swelling,mobility, sinus tract and loss of function between the experimental and control groups. One day. One week. One month. Three months. Six months. Twelve months.
Secondary Outcome Comparison of pre-operative and post-operative radiographic changes between the experimental and control groups. One day. One week. One month. Three months. Six months. Twelve months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dental clinic, Lagos University Teaching Hospital Ishaga road Idi-Araba, Lagos state 12003 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Adedayo Oreoluwa Lawal 51, Agege Motor road, Bishop street Junction Surulere, Lagos state Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adedayo Oreoluwa Lawal 51 Agege motor road, Bishop street junction Surulere, Lagos state Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Donna Umesi Restorative dentistry department Lagos University Teaching Hospital,Idi-Araba 12003 Nigeria
Olabisi Oderinu Restorative dentistry department Lagos University Teaching Hospital, Idi-Araba 12003 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adedayo Lawal oreoluwa84@yahoo.com +234 802 320 2167 51 Agege motor road, Bishop street junction
City Postal code Country Position/Affiliation
Surulere, Lagos state Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Donna Umesi ukchioma@yahoo.com +234 802 302 1700 Restorative dentistry department
City Postal code Country Position/Affiliation
Lagos University Teaching Hospital, Idi-Araba 12003 Nigeria Associate Professor/ Consultant
Role Name Email Phone Street address
Scientific Enquiries Olabisi Oderinu bisioderinu@yahoo.co.uk +234 802 307 7654 Restorative dentistry department
City Postal code Country Position/Affiliation
Lagos University Teaching Hospital, Idi-Araba 12003 Nigeria Senior Lecturer/ Consultant
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