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.: PACTR202005593102009 Date of Approval: 28/05/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Third Molar Surgery
Official scientific title Comparative study on the effect of perioperative dexamethasone, ketoprofen and ice pack compress on postoperative sequelae in mandibular third molar surgery.
Brief summary describing the background and objectives of the trial Surgical removal of impacted third molar is one of the most commonly carried out procedures by oral and maxillofacial surgeons. Different classes of anti-inflammatory drugs, cold packs with or without compression have been used in an attempt to reduce the postoperative sequelae after impacted lower third molar surgery. These sequelae, though transient, can be sources of fear, cause a loss of work hours, limit daily activities, social life, and recreation, and hence affect the quality of life (QoL). A randomized clinical study carried out to ascertain and compare the effect of ketoprofen, dexamethasone and ice pack compress on postoperative sequelae of impacted lower third molar surgery and to compare its effect on the quality of life. Objectives: 1. To ascertain the effect of ketoprofen on postoperative sequelae of impacted lower third molar surgery. 2. To ascertain the effect of dexamethasone on postoperative sequelae of impacted lower third molar surgery. 3. To ascertain the effect of ice packs on postoperative sequelae of impacted lower third molar surgery. 4. To compare the effect of the three therapies on the postoperative sequelae of impacted lower third molar surgery. 5. To compare the quality of life in subjects across the three therapies after ILTM surgery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 16/10/2017
Actual trial start date 08/01/2018
Anticipated date of last follow up 05/10/2018
Actual Last follow-up date 05/10/2018
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 78
Recruitment status Completed
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 from a statistics book 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 Tabs Dexamethasone 8mg stat Start dose Subjects had 8mg tablet of Dexamethasone 1hr preoperatively 27
Experimental Group Tabs Ketoprofen 100mg stat Start dose Subjects had 100mg tablet of Ketoprofen 1hr preoperatively 25
Control Group Ice pack Compress 500ml 500mls of ice pack applied intermittently for 20minutes and rest period of 10 minutes for 6hrs. 500mls of ice pack applied intermittently for 20minutes and rest period of 10 minutes for 6hrs. Each subject had four 500mls ice pack. 26 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects with an impacted lower third molar that necessitates surgical extraction under local anaesthesia. Subjects aged 18 – 45 years. Absence of inflammation Subjects with American Society of Anaesthesiologists (ASA) class 1 Moderately difficult impaction (Modified Pederson difficulty index score 5-6) Pregnant and breast-feeding subjects. Subjects on steroids including contraceptives. Subjects with a history of a hypersensitive reaction to any of the drugs that would be used. Subjects with bleeding dyscrasia. Subjects on anticoagulant therapy. History or presence of peptic ulcer disease. Subjects with renal, hepatic, or cardiovascular disease. Presence of pericoronitis. Subjects with a dental abscess. Subjects who are smokers. Subjects who had received analgesic or anti-inflammatory drugs within the past 72 hours before surgery. Subjects on antibiotics within 72hrs before surgery. Subjects with trismus (inter incisal distance less than 30mm) Subjects with Raynaud phenomenon. Subjects with complete bony impaction. Operating time exceeding30 minutes (time lapse between the beginning of bone removal to end of suturing)152. Subjects who did not consent. History of allergy to amoxicillin, metronidazole or co-codamol. Subjects who are illiterate. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 10/10/2017 University of Maiduguri Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Bama Road Maiduguri 600230 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain, swelling and Trismus. Post-operative day 1, 2 and 7
Secondary Outcome Quality of life Post-operative day 1, 2 and 7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of MAiduguri Teaching Hospital Bama road Maiduguri 600230 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Ibrahim Kayode Suleiman Bama road Maiduguri 600234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ibrahim Kayode Suleiman Bama road Maiduguri 600230 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Hector Oladapo Olasoji Bama Road Maiduguri 600234 Nigeria
Dr. Olutayo James Ishaga road Lagos 100254 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Suleiman kaysuleiman@yahoo.com +2348094855584 Bama road
City Postal code Country Position/Affiliation
Maiduguri 600230 Nigeria Senior Registrar Oral and Maxillofacial Surgery
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Suleiman kaysuleiman@yahoo.com +2348094855584 Bama road
City Postal code Country Position/Affiliation
Maiduguri 600230 Nigeria Senior Registrar Oral and Maxillofacial Surgery
Role Name Email Phone Street address
Public Enquiries Mukthar Modibbo dentmamodibbo@gmail.com +2348065596483 Bama road
City Postal code Country Position/Affiliation
Maiduguri 600230 Nigeria Senior Registrar Oral and Maxillofacial Surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data available on SPSS Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 3yrs open
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