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Trial registered on ANZCTR


Registration number
ACTRN12618000399291
Ethics application status
Approved
Date submitted
23/01/2018
Date registered
20/03/2018
Date last updated
20/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Evaluation and Comparison of the Effectiveness of Platelet Rich Fibrin versus Buccal Advancement Flap Surgery for the Immediate Closure of Acute Oroantral Communications
Scientific title
Comparison of the Clinical Outcomes (pain, analgesics doses taken, swelling) of PRF application versus Buccal Advancement Flap Surgery for the closure of acute oroantral communications (OACs).
Secondary ID [1] 293850 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute oroantral communications 306313 0
Condition category
Condition code
Surgery 305395 305395 0 0
Surgical techniques
Oral and Gastrointestinal 305981 305981 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
In 36 patients, following the extractions of maxillary posterior teeth, Acute oroantral communications (OACs) which were larger than 3mm diameter were detected. In group A, 21 patients were treated with the use of platelet rich fibrin (PRF) and in group B, buccal advancement flap was used in 15 patients.
1st intervention (group A): Two PRF clots were used for the treatment of acute OACs. Blood samples of each patient were taken directly into 2 x 10 mL glass-coated plastic tubes (excluding anticoagulant, and immediately centrifuged at 3000 rpm for 10 min (Elektro-mag, M415P, Istanbul). The platelet-poor plasma was separated from middle part (PRF) that accumulated at the top of the tube and collected the PRF from roughly 2 mm below its’ contact point with the red corpuscles to include any remaining platelets.Then, two PRF clots were gently placed into the extraction cavity and sutured to avoid them from escaping to the sinus and for stabilization.
2nd intervention (group B): Buccal advancement flap was used to close acute oroantral communications. The extraction socket was closed by sliding the buccal flap over the socket and suturing the flap to the undermined palatal mucosa.
All interventions were performed by oral and maxillofacial surgeon.
Intervention code [1] 300111 0
Treatment: Surgery
Comparator / control treatment
Group B: Buccal Advancement Flap surgery
Control group
Active

Outcomes
Primary outcome [1] 304534 0
A visual analogue scale (VAS) (0: no pain -100: severe pain) was used to assess pain.
Timepoint [1] 304534 0
pain was recorded with VAS only postoperatively on days 1, 2, 3, and 7.
Primary outcome [2] 304535 0
The number of analgesics taken was recorded by asking the patients. For the first day check 'how many analgesics did you use after the surgery to come first check up?'. For the second and third check up days 'how many analgesics did you use after the last check up'. and For the 7th day check up 'how many analgesics did you use last 24 hour'.
Timepoint [2] 304535 0
The number of analgesics doses recorded only postoperatively on days 1, 2, 3, and 7.
Primary outcome [3] 304536 0
Swelling was evaluated by using tape measure method by Gabka and Matsumara. Three preoperative measurements were taken with soft tape measure between 5 reference points: tragus to the outer corner of the nose, tragus to the outer corner of the mouth and lateral corner of the eye to the angle of the mandible, were repeated on the 1st, 2nd 3rd and 7th postoperative days. The sum of the 3 preoperative measurements was taken as the baseline for that side. The difference between maximum postoperative measurement and the baseline gave the value of facial swelling for each patient. The swelling values of each patient recorded as a percentage by using the following formula: [(Maximum postoperative value – preoperative value)/preoperative value] x 100 = % of facial swelling.
Timepoint [3] 304536 0
swelling was measured only postoperatively on days 1, 2, 3, and 7.
Secondary outcome [1] 342294 0
Mean duration of the procedure
Timepoint [1] 342294 0
In group A: the operating time was recorded from taking blood samples to the last stitch.
In group B: the operating time was the period between the beginning of incision to the last suture

Eligibility
Key inclusion criteria
Detection of acute oroantral communication (perforation) larger than 3 mm following the extraction of maxillary molar tooth. The volunteers who had neither systemic diseases nor signs of sinus disease. Also, they had no smoking or drinking habits.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who had chronic or acute systemic diseases.

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)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Statistical analyses were performed using Independent Samples t – Test (t), to compare the means of two independent groups. Whenever the data were not normally distributed, Mann - Whitney U test (z) was applied. In addition, the Chi-Square test (x2) was used to compare categorical variables. R statistical software package was used to perform statistical analysis (ver. 2.14.0). Statistical significance was defined at p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/11/2011
Date of last participant enrolment
Anticipated
Actual
28/06/2017
Date of last data collection
Anticipated
Actual
19/07/2017
Sample size
Target
36
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 9515 0
Cyprus
State/province [1] 9515 0
Nicosia

Funding & Sponsors
Funding source category [1] 298472 0
University
Name [1] 298472 0
Near East University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Country [1] 298472 0
Cyprus
Primary sponsor type
University
Name
Near East University, Faculty of Dentistry Department of Oral and Maxillofaical Surgery
Address
Near East University, Near East Boulevard, ZIP: 99138 Nicosia TRNC Mersin 10 - Turkey
Country
Cyprus
Secondary sponsor category [1] 298068 0
None
Name [1] 298068 0
Address [1] 298068 0
Country [1] 298068 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299459 0
Near East University Institutional Review Board
Ethics committee address [1] 299459 0
Ethics committee country [1] 299459 0
Cyprus
Date submitted for ethics approval [1] 299459 0
21/10/2016
Approval date [1] 299459 0
17/11/2016
Ethics approval number [1] 299459 0
NEU/2016/41-340

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

Contacts
Principal investigator
Name 80474 0
Dr Kani Bilginaylar
Address 80474 0
Near East University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Nicosia, Cyprus, Mersin 10 Turkey
Country 80474 0
Turkey
Phone 80474 0
+90 392 680 20 30
Fax 80474 0
+90 392 680 20 25
Email 80474 0
[email protected]
Contact person for public queries
Name 80475 0
Kani Bilginaylar
Address 80475 0
Near East University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Nicosia, Cyprus, Mersin 10 Turkey
Country 80475 0
Turkey
Phone 80475 0
+90 533 832 55 07
Fax 80475 0
+90 392 680 20 25
Email 80475 0
[email protected]
Contact person for scientific queries
Name 80476 0
Kani Bilginaylar
Address 80476 0
Near East University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Nicosia, Cyprus, Mersin 10 Turkey
Country 80476 0
Turkey
Phone 80476 0
+90 533 832 55 07
Fax 80476 0
+90 392 680 20 25
Email 80476 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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