Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000595516
Ethics application status
Approved
Date submitted
22/02/2024
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Date results provided
9/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Paracetamol and Ibuprofen on wound healing in dental extraction patients.
Scientific title
Evaluating and Comparing the Effects of Paracetamol and Ibuprofen on Wound Healing, MMP-9, and TGF-beta1 Levels in Patients Following Upper Third Molar Tooth Extraction.
Secondary ID [1] 311568 0
None
Universal Trial Number (UTN)
U1111-1304-4867
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tooth extraction wound healing. 332933 0
Condition category
Condition code
Surgery 329651 329651 0 0
Other surgery
Oral and Gastrointestinal 330073 330073 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
The volunteer participants were divided into 2 groups using the Block Randomization method as follows:
Group 1: Participants in this group were administered with 500 milligrams of Paracetamol after tooth extraction. They were instructed to take 1 tablet every 6 hours, totaling 10 tablets.
Group 2: Participants in this group were administered with 400 milligrams of Ibuprofen after tooth extraction. They were instructed to take 1 tablet after meals, totaling 10 tablets.
Both groups of volunteers will receive a checklist to remind them to take their medication as prescribed by the dentist and volunteers must bring the checklist to the dentist on the follow-up day.
Intervention code [1] 328031 0
Treatment: Drugs
Comparator / control treatment
This is a randomized controlled trial experimental study that compared the effects of Paracetamol and Ibuprofen on tooth extraction wounds in patients therefore paracetamol is to be used as the reference drug.
Control group
Active

Outcomes
Primary outcome [1] 337454 0
Modified Landry Turnbull and Howley indices (LTHI)
Timepoint [1] 337454 0
3 days and 7 days (primary timepoint) after tooth extraction.
Primary outcome [2] 337455 0
Concentration of MMP-9 (pg/ml) and TGFß1 (pg/ml).
The concentration of MMP-9 (pg/ml) and TGFß1 (pg/ml) indicates the level of wound healing. In cases where the wound heals well, there should be a low concentration of MMP-9 (pg/ml) and a high concentration of TGFß1 (pg/ml). Conversely, if wound healing is poor, there will be a high concentration of MMP-9 (pg/ml) and a low concentration of TGFß1 (pg/ml). MMP-9 and TGFß1 will be assessed together as a composite primary outcome.
Timepoint [2] 337455 0
Comparing the levels of MMP-9 (pg/ml) and TGFß1 (pg/ml) before tooth extraction, 3 days after tooth extraction and 7 days (primary timepoint) after tooth extraction
Secondary outcome [1] 433835 0
Nil
Timepoint [1] 433835 0
Nil

Eligibility
Key inclusion criteria
For the inclusion criteria, subjects were selected as patients who need to remove upper third molar tooth within an age range of 15-30 years, who were of healthy status (American Society of Anesthesiologists: ASA class I and II), and who reported a normal body mass index (BMI) within a range of 18.5-24.5 kg/m2. In addition, they were free from pathological conditions, denied having any history of chronic illnesses and drug allergies.
Minimum age
15 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The terms of exclusion were as follows: 1) Patients who were pregnant, heavy smokers, allergic to paracetamol, ibuprofen, or any anesthetic medications (e.g., mepivacaine and epinephrine-related drugs). 2) Patients who had undergone any pre-existing medical conditions such as hypertension, diabetes, liver disease, kidney disease, blood clotting disorders, and gastritis. 3) Patients who had wounds/injuries in various parts of their bodies prior to initiating the experimental study or those that had severe gingival inflammation (Gingival index > 2). 4). Patients who had taken medication or dietary supplements that could impact the wound healing process. 5) Patients who experienced psychological or communication disorders.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were divided into two groups by using the Block Randomization method from computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated according to the data obtained from the previous correlated study using the STATA® version 16.0 software (StataCorp, LLC, College Station, TX, USA). Initially, the total sample size was comprised of 16 individuals, who were then divided into two groups (n = 8 each). However, the researchers decided to increase the sample size to a total of twenty individuals, which were then divided into two groups (n = 10 each) by including additional participants.
Results were analyzed and expressed as interquartile range (IQR) using the STATA® version 16.0. Median concentrations of MMP-9 and TGF-beta1 in the saliva samples collected at different time points among patients who received paracetamol and ibuprofen were determined and compared using Mann-Whitney U test at a 95% confidence level. Proportions of LTHI values between patients who had received paracetamol and ibuprofen were determined and compared using Fisher’s exact test at a 95% confidence level. The relationship between LTHI values, MMP-9 concentrations, and TGF-beta1 concentrations were determined and compared using Spearman’s correlation coefficient at a 95% confidence level. Accordingly, at least p < 0.05 was considered significantly different.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/10/2022
Date of last participant enrolment
Anticipated
Actual
17/02/2023
Date of last data collection
Anticipated
Actual
17/03/2023
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 26164 0
Thailand
State/province [1] 26164 0
Chiang-Mai

Funding & Sponsors
Funding source category [1] 315868 0
University
Name [1] 315868 0
Residency Training Program in Oral and Maxillofacial, Surgery, Faculty of Dentistry, Chiang Mai University
Country [1] 315868 0
Thailand
Primary sponsor type
University
Name
Residency Training Program in Oral and Maxillofacial, Surgery, Faculty of Dentistry, Chiang Mai University
Address
Country
Thailand
Secondary sponsor category [1] 318040 0
None
Name [1] 318040 0
Address [1] 318040 0
Country [1] 318040 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314717 0
Faculty of Dentistry Human Experimentation Committee
Ethics committee address [1] 314717 0
Ethics committee country [1] 314717 0
Thailand
Date submitted for ethics approval [1] 314717 0
09/09/2022
Approval date [1] 314717 0
17/10/2022
Ethics approval number [1] 314717 0
57/2022

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132502 0
Dr Sumatee Yuthavong
Address 132502 0
Department of Oral and Maxillofacial surgery, Faculty of Dentistry, Chiang Mai University T. Suthep, A. Muang, Chiang Mai 50200 Thailand
Country 132502 0
Thailand
Phone 132502 0
+66876567560
Fax 132502 0
Email 132502 0
[email protected]
Contact person for public queries
Name 132503 0
Sumatee Yuthavong
Address 132503 0
Department of Oral and Maxillofacial surgery, Faculty of Dentistry, Chiang Mai University T. Suthep, A. Muang, Chiang Mai 50200 Thailand
Country 132503 0
Thailand
Phone 132503 0
+66876567560
Fax 132503 0
Email 132503 0
[email protected]
Contact person for scientific queries
Name 132504 0
Sumatee Yuthavong
Address 132504 0
Department of Oral and Maxillofacial surgery, Faculty of Dentistry, Chiang Mai University T. Suthep, A. Muang, Chiang Mai 50200 Thailand
Country 132504 0
Thailand
Phone 132504 0
+66876567560
Fax 132504 0
Email 132504 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21716Informed consent form  [email protected]
21717Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.