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.: PACTR201809637478809 Date of Approval: 03/09/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFICACY OF DICLOFENAC TRANSDERMAL PATCH AND ORAL DICLOFENAC FOLLOWING TRANSALVEOLAR EXTRACTION: A COMPARATIVE STUDY.
Official scientific title EFFICACY OF DICLOFENAC TRANSDERMAL PATCH AND ORAL DICLOFENAC FOLLOWING TRANSALVEOLAR EXTRACTION: A COMPARATIVE STUDY.
Brief summary describing the background and objectives of the trial Pain, swelling and trismus are the most common post operative sequelae resulting from transalveolar extraction of impacted mandibular third molar. These sequelae affect patient’s quality of life and diclofenac which is the most commonly used non-steroidal anti-inflammatory drug (NSAID) has several routes of administration. . Diclofenac transdermal patch which is a form of topical route has the advantage of being an easy, simple route of administration with a constant and continuous delivery of drugs in a controlled manner without gastrointestinal adverse effect and a first pass metabolic effect which is commonly seen in oral diclofenac. Objectives : The objectives of this study is to determine and compare the efficacy of oral diclofenac and transdermal diclofenac patch on pain, swelling and trismus following transalveolar extraction of mandibular third molar.
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: Drugs
Anticipated trial start date 17/09/2018
Actual trial start date
Anticipated date of last follow up 14/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants)
Recruitment status Not yet 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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group EFFICACY OF ORAL DICLOFENAC 6 months each participant will be seen for 7 days Oral diclofenac sodium 50mg 12 hourly. For three days these drugs will be administer to the control group. It will be administered immediately after surgery. 32 Active-Treatment of Control Group
Experimental Group EFFICACY OF DICLOFENAC TRANSDERMAL PATCH Diclofenac transdermal patch 100mg daily for 3 days. Patch diclofenac sodium 100mg in a single dose daily, which will remain at site of application for 24 hours. For three days these drug will be administered to the experimental group. It will be administered immediately after surgery.Diclofenac transdermal patch which is adhesive on the skin, measures 7cm by 6cm in length and breadth respectively will be place on its longitudinal axis on the skin above the third molar-ascending ramus region with its highest point on the tragal-alar line and lowest point 3mm below the lowest margin of the posterior mandibular region. 32
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All subjects with moderate difficulty, using the Pederson’s difficulty index. 2. Subjects willing to sign consent. 3. Subjects presenting with clinical symptoms associated with impacted mandibular third molar 4. Subjects with pathology due to impacted mandibular third molar 5. Subjects with surgical site free of active infection. 6. All subjects literate enough to be able to tell pain experienced using the visual analogue scale. 1. Subjects declining consent 2. History of allergy to diclofenac 3. Pregnant or lactating subjects 4. Immunocompromised subjects 5. Presence of systemic diseases 6. Subjects on anticoagulant therapy 7. Subjects on analgesic at the time of presentation 8. Subjects on oral contraceptive 9. Subjects on corticosteroids 10. Surgical procedure extending beyond twenty five minutes. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 46 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 20/08/2018 UNIVERSITY OF BENIN TEACHING HOSPITAL ETHICS AND RESEARCH COMMITTEE
Ethics Committee Address
Street address City Postal code Country
UNIVERSITY OF BENIN TEACHING HOSPITAL, UGBOWO BENIN CITY 300283 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction in pain, swelling and trismus post transalveolar extraction of impacted mandibular third molar day1, day3, day 7 post operatively.
Secondary Outcome improved quality of life Day 1 to day 7 post operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UNIVERSITY OF BENIN TEACHING HOSPITAL UNIVERSITY OF BENIN TEACHING HOSPITAL ,UGBOWO BENIN CITY 300283 Nigeria
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 UNIVERSITY OF BENIN TEACHING HOSPITAL UNIVERSITY OF BENIN TEACHING HOSPITAL, UGBOWO BENIN CITY 300283 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AIMUAMWOSA OSAGIE osagie35@yahoo.com +2347037852620 UNIVERSITY OF BENIN TEACHING HOSPITAL, UGBOWO,
City Postal code Country Position/Affiliation
BENIN CITY 300283 Nigeria SENIOR REGISTRAR UNIVERSITY OF BENIN TEACHING HOSPITAL
Role Name Email Phone Street address
Public Enquiries OZOMENA OBUEKWE oxobuekwe@yahoo.com +2348038084336 UNIVERSITY OF BENIN TEACHING HOSPITAL, UGBOWO,
City Postal code Country Position/Affiliation
BENIN CITY 300283 Nigeria CONSULTANT UIVERSITY OF BENIN TEACHING HOSPITAL
Role Name Email Phone Street address
Scientific Enquiries Ekaniyere Edetanlen ehiben2002@yahoo.com +2348024223651 UNIVERSITY OF BENIN TEACHING HOSPITAL, UGBOWO,
City Postal code Country Position/Affiliation
BENIN CITY 300283 Nigeria CONSULTANT UIVERSITY OF BENIN TEACHING HOSPITAL
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