Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001146583
Ethics application status
Approved
Date submitted
29/06/2024
Date registered
23/09/2024
Date last updated
23/09/2024
Date data sharing statement initially provided
23/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical and radiographic comparison of extraction socket healing of mandibular third molars following the use of autologous platelet-rich plasma and fibrin :randomized controlled trial.
Scientific title
Efficacy of Autologous Platelet Rich Plasma /Platelet Rich Fibrin in healing of the extraction sockets of mandibular third molars.
Secondary ID [1] 312427 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bony defect 334244 0
Condition category
Condition code
Oral and Gastrointestinal 330906 330906 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CONSORT guidelines 2010 will be followed for reporting the present study. Patients who fulfilled the eligibility criteria will be provided with the study information sheets at the visit, to allow sufficient time to consider whether or not they wished to participate. Preoperative radiographic examination including panoramic or periapical radiographs will be undertaken for all patients.

Preoperative data for each patient encompassed age, gender, , smoking habits, alcohol consumption, indications for extraction, tooth location, and the presence/absence of apical radiolucency. This comprehensive information aims to understand the diverse factors influencing tooth extraction outcomes, particularly in the context of platelet-rich plasma/Fibrin (PRP/PRF) application.

Platelet Rich plasma and Fibrin concentrate preparation

To prepare Platelet-Rich Fibrin (PRF), 5 ml of whole venous blood is collected in each of two sterile vacutainer tubes without anticoagulant. The tubes undergo centrifugation at 3000 rpm for 10 minutes, resulting in three layers: the lower red fraction (red blood cells), the upper straw-colored layer Platelet rich plasma PRP , and the middle fraction, which is collected 2 mm below the lower dividing line, representing the PRF.
Third Molar Extraction
A full-thickness mucoperiosteal flap wIll be raised, and one releasing incision will be made as needed to allow socket examination and facilitate closure. Tooth extractions will be performed in 60 minutes. Post-extraction, sockets In the PRP /PRF group, sockets will be filled with Platelet-Rich Plasma and PRF, while the control group Will receive none. Mucosal flaps will be closed using resorbable sutures, ensuring complete soft tissue closure. Antibiotics will be prescribed; post-operative pain control will be provided with pain killer .

Outcome measures
Health-related quality of life index

The health-related quality of life questionnaire assessed patient perception of recovery after tooth removal in four main areas:
pain,
oral function,
general activity
and other symptoms.

Pain definitions referred to the severity of pain and the consumption of analgesics.
Oral function dealt specifically with the ability to eat food, swallowing, mouth opening and speech.
General activity variables targeted ability to practise routine daily activities, sleeping and school/ work attendance.
Other symptoms included: presence of swelling, bruising, bleeding, bad taste or halitosis and food stagnation in surgical sites.

For each question, the patients will be ask to mark the answer best describing how they felt (1, not at all; 2, very little; 3, some; 4, quite a lot; and 5, very much).

The VAS consisted of a 10-cm line anchored at one end by the label ‘No pain’ and at the other end ‘Worst possible pain’. The patients were given a form with seven scales for the respective days after extraction. The questionnaire also included follow up visit assessment on day 1,3 and 7 and daily doses of the analgesics consumed on each postoperative day.

Socket complications

The patients will be assessed 1 week after extraction for an assessment of socket complications, if any. Normal healing was recorded on observation of an alveolus with normal granulation tissue in the presence or absence of pain. Criteria for socket complications were:

• Alveolar osteitis diagnosed by the presence of a persistent throbbing post-operative pain in and around the extraction socket, will not adequately relieved by prescribed analgesics.

Other complications will also be assessed
Flap Dehiscence
Flap dehiscence
Infection




Soft tissue healing index

At the same post-operative appointment at 1 week following extraction, an assessment of the soft tissue surrounding the socket using the healing index of Landry et al will carry out to evaluate the extent of soft tissue healing after tooth removal. This intended to assess and grade the colour of tissues, epithelialisation of wound margins, presence of bleeding on palpation, granulation and suppuration. Two oral surgeons will carried out the assessments independently.

Radiographic assessment
For the assessment of the newly formed bone in extraction sockets, standardised periapical radiographs will be taken .Two methods of radiographic assessment will be carry out: a subjective evaluation and bone density analysis.

Two observers, will carry out a radiographic evaluation of the bone density of the sockets. The observers, who will be both unaware of the patient allocation to PRP/PRF or control groups, will ask to assess bone density on two different automated softwares.
The observers will meet for calibration and discussions on image characteristics, and evaluations will be made by consensus agreement of the two observers.
In order to analyse the radiographic images by the image analysis software. All radiographs will be digitised at 600 dpi spatial resolution and 8-bit depth . An automated analysis of the images will be carry out through the use of the
image J histogram and adobe photoshop CS2 software.

For image analysis, three areas of interest (AOIs) or sampling boxes will be select for each socket:

• Sample one: the upper border of the AOI box will locate approximately 2 mm below a line connecting the mesial and distal margins of the extraction socket.

• Sample two: the AOI box will locate in the middle part of the socket.

• Sample three: the lower border of the AOI box will locate approximately 2 mm coronal to the most apical extension of the socket visible on the radiograph.

This results in three AOIs for multi-rooted teeth. Dimensions of the AOI boxes will standardised at 1 mm in height (apical-coronal) and 1 mm in width (mesial-distal).

Maxillofacial surgeon will deliver the intervention (60mins)
Intervention code [1] 328934 0
Treatment: Surgery
Comparator / control treatment
control group underwent surgical extraction without placement of Platelet Rich Plasma Prp/ Platelet Rich Fibrin prf.
All variables assessed for intervention group will also be assessed in the similar manner for the control group as well.
Control group
Active

Outcomes
Primary outcome [1] 338670 0
hard tissue bone formation after 3 months
Timepoint [1] 338670 0
3 months post extraction of mandibular third molar
Primary outcome [2] 339232 0
clinical healing index of Landry et al will be used to evaluate the extent of soft tissue healing after third mandibular molar removal
Timepoint [2] 339232 0
7 days post extraction of mandibular third molar
Secondary outcome [1] 436955 0
Health-related quality of life index

The health-related quality of life questionnaire assessed patient perception of recovery after tooth removal in four main areas:
pain,
oral function,
general activity
and other symptoms.

Pain definitions referred to the severity of pain and the consumption of analgesics.
Oral function dealt specifically with the ability to eat food, swallowing, mouth opening and speech.
General activity variables targeted ability to practise routine daily activities, sleeping and school/ work attendance.
Other symptoms included: presence of swelling, bruising, bleeding, bad taste or halitosis and food stagnation in surgical sites.
Timepoint [1] 436955 0
7 days post extraction of mandibular third molar

For pain The patients were given a form with seven scales for the respective days after extraction. The questionnaire also included follow up visit assessment on day 1,3 and 7 and daily doses of the analgesics consumed on each postoperative day.
Secondary outcome [2] 439181 0
Socket Complication
Flap dehiscence
infection
Timepoint [2] 439181 0
7 days postoperatively

Eligibility
Key inclusion criteria
1 Healthy males and females of age range between 18 to 45 years.
2. Patients with a demonstrable need of removal of mandibular third molar under local anaesthesia.
3. Patients who are well oriented and capable and will be willing to cooperate with the requirements of the study protocol, and to provide an appropriate written informed consent.
4. Mesioangular and pell and greogery class II/ class B lower third molar impactions.( will be diagnosed on periapical radiographs and OPG)
5. Surgery duration less than 90 mins.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy, being a nursing mother or having childbearing potential
2. Platelet dysfunction syndrome or critical thrombocytopenia.
3. Under treatment with NSAIDs including aspirin, antibiotics, systematic corticosteroids, anticoagulants , immunosuppressive drugs and NOACs.
4. Surgery exceeding 90 mins.
5. Un cooperative patients

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
outcomes, differences between the PRP/PRF and control groups will be tested by non-parametric MannWhitney U-tests. Chi-square tests will be used to test differences in healing complications and subjective radiographic evaluation outcomes between groups. The statistical significance of any differences in trabecular parameters between the groups will be determined using independent sample t tests. All comparisons will be conducted at a 5% level of significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 26399 0
Pakistan
State/province [1] 26399 0
PUNJAB/islamabad
Country [2] 26400 0
Pakistan
State/province [2] 26400 0
PUNJAB/islamabad

Funding & Sponsors
Funding source category [1] 316839 0
Hospital
Name [1] 316839 0
shifa dental hospital
Country [1] 316839 0
Pakistan
Primary sponsor type
Individual
Name
Ufaq rao ,shifa dental hospital
Address
Country
Pakistan
Secondary sponsor category [1] 319073 0
Hospital
Name [1] 319073 0
Shifa dental hospital
Address [1] 319073 0
Country [1] 319073 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315608 0
SCD Ethics Evaluation No: SCD-2024/07
Ethics committee address [1] 315608 0
Ethics committee country [1] 315608 0
Pakistan
Date submitted for ethics approval [1] 315608 0
03/03/2024
Approval date [1] 315608 0
20/06/2024
Ethics approval number [1] 315608 0

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

Contacts
Principal investigator
Name 135234 0
Dr Ufaq Rao
Address 135234 0
Shifa Dental Hospital, 956 West Service Road, Sohan Interchange Dhok Kala Khan, Main Islamabad Expressway, Islamabad. 46000
Country 135234 0
Pakistan
Phone 135234 0
+92 332 5020301
Fax 135234 0
Email 135234 0
[email protected]
Contact person for public queries
Name 135235 0
Muhammad Adil Asim
Address 135235 0
Najran university, King Abdul Aziz Road, PO Box 1988 Najran KSA
Country 135235 0
Saudi Arabia
Phone 135235 0
+966537985134
Fax 135235 0
Email 135235 0
[email protected]
Contact person for scientific queries
Name 135236 0
Muhammad Adil Asim
Address 135236 0
Najran university, King Abdul Aziz Road, PO Box 1988 Najran KSA
Country 135236 0
Saudi Arabia
Phone 135236 0
+966537985134
Fax 135236 0
Email 135236 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?

No Supporting Document Provided



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.