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Trial registered on ANZCTR


Registration number
ACTRN12619001349134
Ethics application status
Approved
Date submitted
24/05/2019
Date registered
1/10/2019
Date last updated
1/10/2019
Date data sharing statement initially provided
1/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of submucosal administration of methylprednisolone and dexamethasone in comparison to control group on pain, swelling, and trismus after third molar surgery
Scientific title
The effectiveness of submucosal administration of methylprednisolone and dexamethasone in comparison to placebo after third molar surgery: a double blinded parallel arm randomized clinical trial
Secondary ID [1] 298312 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Third molar surgery 312947 0
Pericoronitis 312948 0
Condition category
Condition code
Surgery 311434 311434 0 0
Other surgery
Oral and Gastrointestinal 311435 311435 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study will be conducted in oral and maxillofacial ward of Islamic International Dental College Islamabad
A double blinded, randomized controlled trial will be carried out.
A total of 90 patients will be included. 25 % patients were added to compensate for the drop out. There will be three groups. Group a will be given submucosal dexamethasone 8 mg once only before the start of the procedure. Group b will be given 40 mg submucosal methyl prednisolone once only and group c will not be given any drug preoperatively and would serve as control group.
An independent researcher "I" makes random allocation cards using computer-generated random numbers. He keeps the original random allocation sequences in an inaccessible third place and works with a copy. He will open the envelope for every patient at start of treatment and will tell Dr A that which patient gets what form of intervention. Dr A will give the patient one of two drugs. After this, Dr B will perform the surgical procedure i.e removal of the impacted third molar. Before the start of the surgical procedure patient will be asked the level of pain on the vas score from 1 to 5(1 being very less and 5 being worst). Trismus and mouth opening will be evaluated using the Vernier calipers and measuring the distance between upper and lower teeth. Swelling will be measured by measuring the distance between 4 points. Evaluated by a modification of tape measuring method described by Schultze-Mosgau et al. Two measurements were made between three reference points:Tragus and the corner of the mouth and progonion and center of mouth. The preoperative sum of the two measurements was considered as the baseline for that side. Data analysis would be done through SPSS. A p value of 0.05 will be considered to be arbitrarily significant.

Intervention code [1] 314545 0
Treatment: Drugs
Comparator / control treatment
group c will not be given any drug preoperatively and would serve as control group.
Control group
Active

Outcomes
Primary outcome [1] 320168 0
Post op trismus will be evaluated on 2st, 3rd and 7th post op day.
Trismus will be evaluated through measuring the interincisal opening at 2st ,3rd and 7th day.
Timepoint [1] 320168 0
3rd primary time point
2nd and 7th post op day post enrollment days
Primary outcome [2] 320519 0
Post op swelling will be evaluated on 2st, 3rd and 7th post op day.
Swelling will be evaluated by measuring the distance between tragus of ear and corner of mouth and then tragus of ear and progonion. The mean of two measurements will be recorded.

Timepoint [2] 320519 0
3rd post op day is primary time point
2nd nd 7th post op day is post enrollment time
Secondary outcome [1] 370755 0
Pain will be evaluated through the Vas score
Timepoint [1] 370755 0
2nd,3rd and 7th post op day
Secondary outcome [2] 372864 0
Number and time of analgesics taken described by the patient. The patient will keep a record in his diary
Timepoint [2] 372864 0
2nd, 3rd and 7th post op day

Eligibility
Key inclusion criteria
Patients in the age group – 20 to 50 years
Patients with mesioangular impactions Class II position B third molar according to the Pell and Gregory’s classification.
Patient with no medical conditions
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients requiring prophylactic antibiotics before surgical procedure. The following patients will be excluded because taking antibiotic before the treatment will subside the infection and pain and it will act as confounding factor with the study design
• Patients suffering from any mental disorders or with any chronic pain problems. The following patients will be excluded because of ethical concerns.
• Pregnant or lactating women. The following patients will be excluded to avoid any harm to pregnancy and fetus.
• Patients reporting hypersensitivity to steroids. The following patients will be excluded because intervention includes application of steroids and they can have hypersensitivity or anaphylactic reaction
• Patients taking nonsteroidal anti-inflammatory drugs in the 3 days before participation in the study. The following patients will be excluded because taking NSAIDS before the treatment will subside the infection and pain and it will act as confounding factor with the study design
• Patients having acute pulpitis, abscesses, or other acute infections. The following patients will be excluded because of ethical concerns.
• Patients with systemic disorders
• Patients on long-term steroids

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent researcher "I" makes random allocation cards using computer-generated random numbers. He keeps the original random allocation sequences in an inaccessible third place and works with a copy. He will open the envelope for every patient at start of treatment and will tell Dr A that which patient gets what form of intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2019
Actual
Date of last participant enrolment
Anticipated
15/01/2020
Actual
Date of last data collection
Anticipated
10/02/2020
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 21524 0
Pakistan
State/province [1] 21524 0

Funding & Sponsors
Funding source category [1] 302854 0
Self funded/Unfunded
Name [1] 302854 0
Dr Kinza Ayub
Country [1] 302854 0
Pakistan
Primary sponsor type
Individual
Name
Dr Kinza Ayub
Address
Islamic International Dental Hospital, Muhammad Mansha Yaar road G7/4 Islamabad postal code 44000
Country
Pakistan
Secondary sponsor category [1] 302804 0
Individual
Name [1] 302804 0
Dr Kamran Khan
Address [1] 302804 0
Islamic International Dental Hospital, Muhammad Mansha Yaar road G7/4 Islamabad postal code 44000
Country [1] 302804 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303428 0
Institutional review committee, Islamic International dental college, Riphah international university Islamabad
Ethics committee address [1] 303428 0
Riphah International University I-14 near Hajj complex Islamabad capital Territory 44000
Ethics committee country [1] 303428 0
Pakistan
Date submitted for ethics approval [1] 303428 0
20/12/2018
Approval date [1] 303428 0
28/12/2018
Ethics approval number [1] 303428 0

Summary
Brief summary
The purpose of the study is to compare the efficacy of submucosal injection of methylprednisolone, dexamethasone and placebo prior to thrid molar extraction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93646 0
Dr Kinza Ayub
Address 93646 0
Islamic International dental hospital Muhammad Mansha Yaar Road Islamabad 44000
Country 93646 0
Pakistan
Phone 93646 0
+92 315 5099957
Fax 93646 0
Email 93646 0
[email protected]
Contact person for public queries
Name 93647 0
Kinza Ayub
Address 93647 0
Islamic International dental hospital Muhammad Mansha Yaar Road Islamabad 44000
Country 93647 0
Pakistan
Phone 93647 0
+92 315 5099957
Fax 93647 0
Email 93647 0
[email protected]
Contact person for scientific queries
Name 93648 0
Kinza Ayub
Address 93648 0
Islamic International dental hospital Muhammad Mansha Yaar Road Islamabad 44000
Country 93648 0
Pakistan
Phone 93648 0
+92 315 5099957
Fax 93648 0
Email 93648 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participant number, type of intervention, results
When will data be available (start and end dates)?
after the completion of study, no end date for availability
Available to whom?
everyone
Available for what types of analyses?
Future studies
How or where can data be obtained?
in form of excel sheet by emailing the principle investigator [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2151Ethical approval    377647-(Uploaded-23-05-2019-04-32-18)-Study-related document.jpg



Results publications and other study-related documents

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