Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000396820
Ethics application status
Approved
Date submitted
24/01/2021
Date registered
9/04/2021
Date last updated
4/04/2022
Date data sharing statement initially provided
9/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A method of knotless wound closure in third molar surgery: a comparison between conventional absorbable sutures and knotless sutures using a split-mouth design.
Scientific title
A randomised controlled trial comparing the efficacy of conventional absorbable sutures and knotless absorbable sutures using a split-mouth design.
Secondary ID [1] 303036 0
Nil known
Universal Trial Number (UTN)
U1111-1259-5457
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impacted third molars 320117 0
Condition category
Condition code
Oral and Gastrointestinal 318056 318056 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 318057 318057 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The planned intervention uses COVIDIEN 3-0 V-Loc (VLOCM1824) knotless sutures for wound closure following surgical third molar removal. The intervention will be administered by the principal investigator, a dental council registered practitioner.

The overall duration of the procedure is between 60-90 minutes, 20-30 minutes for the removal of each third molar as well as the closure of the site using the 1) knotless suture in the intervention site/side and 2) closure using the control material (current institutional standard, 3-0 vicryl rapide).

The suture material is absorbable and do not commonly require removal.
Intervention code [1] 319335 0
Treatment: Other
Comparator / control treatment
The control involves wound closure using conventional absorbable sutures, ETHICON 3-0 Vicryl Rapide VR416, which is a commonly chosen material for intra-oral wound closure in New Zealand.

This will be administered by the principal investigator, a dental council registered practitioner. The overall duration of the procedure is between 60-90 minutes, 20-30 minutes for the removal of each third molar as well as the closure of the site using the 1) knotless suture in the intervention site/side and 2) closure using the control material (current institutional standard, 3-0 vicryl rapide).

The sutures are not commonly removed at a later time because the material is absorbable.
Control group
Active

Outcomes
Primary outcome [1] 326049 0
Post-operative pain

Assessed using a 100mm continuous visual analogue scale, with 0 representing no pain and the 100mm mark representing the worst pain imaginable to the patient. The distance between the 0 mark and the mark made by the patient denotes their perceived pain score.
Timepoint [1] 326049 0
48 hours

Patients will be individually reviewed 48h following the procedure, in a clinical setting.
Primary outcome [2] 326050 0
Post-operative swelling

Facial swelling will be determined by tape measurements between the tragus and soft tissue pogonion (A), tragus and lateral corner of the mouth (B), lateral corner of the eye and the angle of the mandible (C). Facial measurements will be calculated as: (A + B + C)/3, and facial swelling (%) will be calculated as: [(postoperative measurement - preoperative measurement)/preoperative measurement] × 100% (Baqain et al., 2012).
Timepoint [2] 326050 0
48h

Patients will be individually reviewed 48h following the procedure, in a clinical setting.
Primary outcome [3] 326051 0
Third molar wound closure time

The time taken to remove the third molar in question as well as the time taken to close the site/side with the a) intervention (knotless sutures) and b) control (conventional sutures). This is measured from the first point of application of the suture to the tissues to the time the final knot is cut. This will be measured using a digital stopwatch by a circulating staff member not directly involved in carrying out the procedure.
Timepoint [3] 326051 0
The wound closure time will be assessed at the completion of the procedure.
Secondary outcome [1] 389984 0
Post-operative pain

Assessed using a 100mm continuous visual analogue scale, with 0 representing no pain and the 100mm mark representing the worst pain imaginable to the patient. The distance between the 0 mark and the mark made by the patient denotes their perceived pain score.
Timepoint [1] 389984 0
Day 7

Patients will be individually reviewed 7 days following the procedure, in a clinical setting.
Secondary outcome [2] 389985 0
Post-operative swelling

Facial swelling will be determined by tape measurements between the tragus and soft tissue pogonion (A), tragus and lateral corner of the mouth (B), lateral corner of the eye and the angle of the mandible (C). Facial measurements will be calculated as: (A + B + C)/3, and facial swelling (%) will be calculated as: [(postoperative measurement - preoperative measurement)/preoperative measurement] × 100% (Baqain et al., 2012).
Timepoint [2] 389985 0
Day 7

Patients will be individually reviewed 7 days following the procedure, in a clinical setting.

Eligibility
Key inclusion criteria
1. Patients referred for third molar removal from a primary care provider
2. Patients who volunteer participation
3. Patients may be either male or female
4. The patient has been screened by the primary investigator or supervising specialist for suitability to participate in the study
5. Are aged between 18 and 44 years
6. Are able to understand verbal and written instructions.
7. Present with bilateral similarly impacted mandibular third molars as determined using Winter’s (1926) classification system , requiring surgical removal
8. Are able to tolerate outpatient oral surgery under local anaesthetic and intravenous sedation
9. ASA l or ll
10. The patient has provided informed consent regarding:
a. Participation in the study
i. The use of knotless sutures in the closure of the surgical wound
b. Surgical removal of third molars under local anaesthetic and intravenous sedation
Minimum age
18 Years
Maximum age
44 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. American society of anaesthesiologists (ASA) physical classification III or IV
2. Polypharmacy (greater than or equal to 5) medications
4. Patients contraindicated to undergo surgical third molar removal
5. Patients contraindicated to treatment under monoagent midazolam IV sedation
6. Opioid and illict drug addiction
7. Patients that have allergies or contraindications to the procedural usage of:
a. midazolam
b. dexamethasone
c. parecoxib
d. paracetamol
e. ibuprofen
f. co-amoxiclav
g. cefazolin
h. clindamycin
i. chlorhexidine
8. The presence of symptomatic pericoronitis.
9. The presence of other pathology in the oral cavity.
10. Patients with poor oral hygiene (plaque >1/3 of tooth surface).
11. Pregnant or lactating women.
12. Male patients who do not agree to facial hair removal.
13. Patients who are unable to give informed consent.
14. Patients who decline participation.
15. Patients who are unable to attend the required follow-up appointments.
16. Patients who are unable to comprehend directions and instructions.
17. Patients unwilling to trim facial hair for the purposes for the measurement of facial swelling

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation

Allocations of the intervention to each side will be sealed in opaque envelopes, drawn at random and recorded in the patient's file.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Split-mouth design (parallel case-cross over):
One side is randomly allocated the intervention and the contralateral side is allocated the control treatment. The number of right and left sided interventions will be equal to control for the handedness of the clinician.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size.
Power analysis yielded a sample size of 63 participants based on a paired sample t-test analysis with alpha of 0.01, power of 0.9, and a moderate effect size (Cohen’s d = 0.5). Previous research supports that moderate to large effect sizes can be expected for our key outcome, closure time (Durand, 2017; Zhu et al., 2017). Furthermore, a simulation study on the sample considerations of split mouth designs also indicated that a sample size of approximately 60 participants would be appropriate. 70 participants will be recruited to account for possible drop-out and data loss from participant protocol deviation.

Statistical approach.
Statistical analyses will be conducted using the statistical programming language R. Our outcome variables, closure time, inflammation, and pain, will be modelled using separate mixed models Analyses of Variance (ANOVA) with suture type as a within-subjects variable and age, sex, and X, Y, Z as between-subjects variables. In the case of inflammation and pain, we will use a repeated measures design to account for multiple follow-ups. A post-hoc polynomial comparison of follow-up outcomes by suture type will also be used to determine whether the trajectory of healing differed significantly between suture types. In all cases, we will use an alpha of 0.01, more stringent than the traditional 0.05. Using a lower alpha allows us to be more certain of our findings and also implicitly controls for the multiple comparisons we’re making across different outcome variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2021
Actual
31/05/2021
Date of last participant enrolment
Anticipated
6/12/2021
Actual
15/03/2022
Date of last data collection
Anticipated
23/12/2021
Actual
25/03/2022
Sample size
Target
70
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 23300 0
New Zealand
State/province [1] 23300 0
Southland
Country [2] 23301 0
New Zealand
State/province [2] 23301 0
Otago

Funding & Sponsors
Funding source category [1] 307449 0
University
Name [1] 307449 0
Sir John Walsh Research Institute, University of Otago
Country [1] 307449 0
New Zealand
Primary sponsor type
Individual
Name
Nigel Tan
Address
PO Box 7039
South Invercargill 9844
Invercargill
Southland
Country
New Zealand
Secondary sponsor category [1] 308122 0
None
Name [1] 308122 0
Address [1] 308122 0
Country [1] 308122 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307527 0
Health and disability ethics committee New Zealand
Ethics committee address [1] 307527 0
Ethics committee country [1] 307527 0
New Zealand
Date submitted for ethics approval [1] 307527 0
24/01/2021
Approval date [1] 307527 0
10/05/2021
Ethics approval number [1] 307527 0
21/NTA/30

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

Contacts
Principal investigator
Name 107550 0
Mr Nigel Tan
Address 107550 0
Sir John Walsh Research Institute
Faculty of Dentistry, University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 107550 0
New Zealand
Phone 107550 0
+64 2102844135
Fax 107550 0
Email 107550 0
[email protected]
Contact person for public queries
Name 107551 0
Nigel Tan
Address 107551 0
Sir John Walsh Research Institute
Faculty of Dentistry, University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 107551 0
New Zealand
Phone 107551 0
+64 3479 5661
Fax 107551 0
Email 107551 0
[email protected]
Contact person for scientific queries
Name 107552 0
Nigel Tan
Address 107552 0
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 107552 0
New Zealand
Phone 107552 0
+64 3479 5661
Fax 107552 0
Email 107552 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
To protect participant anonymity and privacy.


What supporting documents are/will be available?




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.