Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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PACTR |
Last refreshed on:
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29 May 2023 |
Main ID: |
PACTR201805003296247 |
Date of registration:
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05/04/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Posterior root canal treatment outcome and antibacterial efficacy using conventional irrigation versus combined with passive ultrasonic irrigation
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Scientific title:
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Posterior root canal treatment outcome and antibacterial efficacy employing conventional irrigation alone versus combined with passive ultrasonic irrigation |
Date of first enrolment:
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03/05/2017 |
Target sample size:
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60 |
Recruitment status: |
Other |
URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3296 |
Study type:
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Interventional |
Study design:
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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
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Phase:
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Not Applicable
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Olabisi
Oderinu |
Address:
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Restorative dentistry department
12003
Lagos University Teaching Hospital, Idi-Araba
Nigeria |
Telephone:
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+234 802 307 7654 |
Email:
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bisioderinu@yahoo.co.uk |
Affiliation:
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Senior Lecturer/ Consultant |
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Name:
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Donna
Umesi |
Address:
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Restorative dentistry department
12003
Lagos University Teaching Hospital, Idi-Araba
Nigeria |
Telephone:
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+234 802 302 1700 |
Email:
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ukchioma@yahoo.com |
Affiliation:
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Associate Professor/ Consultant |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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.
Exclusion criteria: 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.
Age minimum:
18 Year(s)
Age maximum:
70 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Oral Health
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Irreversible pulpitis, apical periodontitis
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Oral Health Irreversible pulpitis, apical periodontitis
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Intervention(s)
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Passive ultrasonic irrigation
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Conventional syringe irrigation
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Primary Outcome(s)
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The comparison of the reduction in bacterial colony forming units between the experimental and control groups.
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Secondary Outcome(s)
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Comparison of pre-operative and post-operative radiographic changes between the experimental and control groups.
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Comparison of the incidence of pain, swelling,mobility, sinus tract and loss of function between the experimental and control groups.
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Source(s) of Monetary Support
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Adedayo Oreoluwa Lawal
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Ethics review
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Status: Approved
Approval date: 16/08/2016
Contact:
Lagos University Teaching Hospital Health Research Ethics Committee.
+234 1 5850737
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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