Wound HealA-PRFNCT03703479
Effect of A-PRF After Removal of Wisdom Teeth
A study testing autologous blood clot made from the patient own clot without any additive in people with Wound Heal, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
To evaluate the healing effect of advanced platelet-rich fibrin (blood clot charged with growth factors) taken from the patient own blood on the extraction site. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- autologous blood clot made from the patient own clot without any additive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Oct 2018to 24 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients above 18 years old with mirror image vertical or mesioangular bilateral impacted mandibular third molars
Who cannot join
- Missing second molars or indicated for extraction (un-restorable and remaining roots).
- Patients under immunosuppressant and patients with acute infection.
- Patients who fail to attend for follow-up appointments.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdul Aziz University
Jeddah, Mecca Region, 21589
About this study
Official title: The Effect of Advanced Platelet Rich Fibrin in Alveolar Defect After Removal of Bilateral Mandibular Third Molar
To evaluate the healing effect of advanced platelet-rich fibrin (blood clot charged with growth factors) taken from the patient own blood on the extraction site.
Read the detailed description
This is a randomized double-blind clinical study. A preoperative and radiographic evaluation will be done in order to select the patients.
Inclusion criteria are healthy patients above 18 years old with vertical or mesioangular bilateral impacted mandibular third molars. Exclusion criteria are missing second molars or indicated for extraction (un-restorable and remaining roots), patients under immunosuppressant and patients with acute infection. Those who fail to attend for follow-up appointments will be excluded.
The probing depth (PD) and clinical attachment level (CAL) distal to the second molar will be measured before each procedure. All patients will undergo bilateral removal of 3rd molar in a single appointment. Envelope flap with distal extension and a full-thickness mucoperiosteal flap will be utilized and the teeth will be removed with elevators. Bone removal will be utilized if needed.
Following the extraction, venous blood will be withdrawn to fill 2 tubes of 10mL each (sterile vacuum plain tube for A-PRF™ +). The blood tubes will be spun in the centrifugation machine for 13 minutes at 1300 rpm then it is pressed in PRF Box to form PRF clots which will be placed in one the extraction socket while the other socket will not receive a PRF (control).Randomization will be done using a coin toss.
Both extraction cavities will be closed using 3-4 interrupted sutures using 3.0 chromic gut sutures.
Postoperatively, all patients will be treated with oral antibiotic amoxicillin 500 mg and non-steroidal anti-inflammatory medications ibuprofen 600mg in case. also, all patients will be instructed to rinse with 0.2 % Chlorhexidine mouthwash for seven days postoperative.
On the 7th,15th and 90th days, patients will be asked about pain using visual analog scale (VAS) and whether they have any concern related to extraction socket statuses like halitosis, empty socket, open socket, dehiscence, and infection signs including swelling, pus, or fever.
They will also undergo a clinical examination at this visit and the consecutive visits. The following measures will be assessed during each clinical examination: the presence of a pocket distal to the adjacent second molar measuring the pocket depth and clinical attachment level and any signs of infection.
Data will be analyzed using statistical software. Analysis of multivariate regression will be used. The healing status will be compared between the graft site and the control site. Results will be interpreted to be statistically significant if they have a P-value of less than 0.05
- Conditions
- Wound Heal
- Being tested
- autologous blood clot made from the patient own clot without any additive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous blood clot made from the patient own clot without any additiveOther
advanced Platelet-rich fibrin clot is made from venous blood withdrawn from the patient
| Study group | Role | What they receive |
|---|---|---|
| A-PRF group | Experimental | Socket site that will receive A-PRF clot Receives: Other: autologous blood clot made from the patient own clot without any additive |
| control | No intervention | socket site that will not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss)
Periodontal healing is evaluated based on changes in clinical attachment loss (mm)
Measured: At baseline and at follow-up 4 weeks and 12 weeks after extraction
Secondary outcomes (1)
Pain reported by the patient according to the visual analogue scale (VAS)
Pain reported by the patient according to the visual analogue scale (VAS) will be evaluated at first follow-up visit, the patient will score the pain suffered at each site on 0-10 scale where 0 = no pain and 10 = sever pain
Measured: 7 days after the extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start20 Oct 2018
- Primary completion20 Feb 2019
- Study completion24 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- spilt mouth design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, talal zahid, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703479
- Sponsor's protocol ID
- 085-10-17
- Acronym
- A-PRF
- Status last verified
- Mar 2019
- First submitted
- 8 Oct 2018
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zahid TM, Nadershah M. Effect of Advanced Platelet-rich Fibrin on Wound Healing after Third Molar Extraction: A Split-mouth Randomized Double-blind Study. J Contemp Dent Pract. 2019 Oct 1;20(10):1164-1170.
PubMed 31883251
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Advanced Platelet Rich Fibrin in Alveolar Defect After Removal of Bilateral Mandibular Third Molar
- ClinicalTrials.gov ID
- NCT03703479
- Acronym / sponsor ID
- A-PRF / 085-10-17
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 24 Mar 2019 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the healing effect of advanced platelet-rich fibrin (blood clot charged with growth factors) taken from the patient own blood on the extraction site.
Detailed description
This is a randomized double-blind clinical study. A preoperative and radiographic evaluation will be done in order to select the patients.
Inclusion criteria are healthy patients above 18 years old with vertical or mesioangular bilateral impacted mandibular third molars. Exclusion criteria are missing second molars or indicated for extraction (un-restorable and remaining roots), patients under immunosuppressant and patients with acute infection. Those who fail to attend for follow-up appointments will be excluded.
The probing depth (PD) and clinical attachment level (CAL) distal to the second molar will be measured before each procedure. All patients will undergo bilateral removal of 3rd molar in a single appointment. Envelope flap with distal extension and a full-thickness mucoperiosteal flap will be utilized and the teeth will be removed with elevators. Bone removal will be utilized if needed.
Following the extraction, venous blood will be withdrawn to fill 2 tubes of 10mL each (sterile vacuum plain tube for A-PRF™ +). The blood tubes will be spun in the centrifugation machine for 13 minutes at 1300 rpm then it is pressed in PRF Box to form PRF clots which will be placed in one the extraction socket while the other socket will not receive a PRF (control).Randomization will be done using a coin toss.
Both extraction cavities will be closed using 3-4 interrupted sutures using 3.0 chromic gut sutures.
Postoperatively, all patients will be treated with oral antibiotic amoxicillin 500 mg and non-steroidal anti-inflammatory medications ibuprofen 600mg in case. also, all patients will be instructed to rinse with 0.2 % Chlorhexidine mouthwash for seven days postoperative.
On the 7th,15th and 90th days, patients will be asked about pain using visual analog scale (VAS) and whether they have any concern related to extraction socket statuses like halitosis, empty socket, open socket, dehiscence, and infection signs including swelling, pus, or fever.
They will also undergo a clinical examination at this visit and the consecutive visits. The following measures will be assessed during each clinical examination: the presence of a pocket distal to the adjacent second molar measuring the pocket depth and clinical attachment level and any signs of infection.
Data will be analyzed using statistical software. Analysis of multivariate regression will be used. The healing status will be compared between the graft site and the control site. Results will be interpreted to be statistically significant if they have a P-value of less than 0.05
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- spilt mouth design
| Arm | Type | Receives |
|---|---|---|
| A-PRF group | Experimental | Other: autologous blood clot made from the patient own clot without any additiveSocket site that will receive A-PRF clot |
| control | No intervention | –socket site that will not receive any intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy patients above 18 years old with mirror image vertical or mesioangular bilateral impacted mandibular third molars
Key exclusion criteria (3 listed)
- Missing second molars or indicated for extraction (un-restorable and remaining roots).
- Patients under immunosuppressant and patients with acute infection.
- Patients who fail to attend for follow-up appointments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous blood clot made from the patient own clot without any additiveadvanced Platelet-rich fibrin clot is made from venous blood withdrawn from the patient | Other | A-PRF group |
Primary outcome
Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss)
Time frame: At baseline and at follow-up 4 weeks and 12 weeks after extraction
Periodontal healing is evaluated based on changes in clinical attachment loss (mm)
1 secondary outcome
Pain reported by the patient according to the visual analogue scale (VAS)
Time frame: 7 days after the extraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Derived from this study: PubMed 31883251Zahid TM, Nadershah M. Effect of Advanced Platelet-rich Fibrin on Wound Healing after Third Molar Extraction: A Split-mouth Randomized Double-blind Study. J Contemp Dent Pract. 2019 Oct 1;20(10):1164-1170.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous blood clot made from the patient own clot without any additive in people with Wound Heal, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss) (time frame: At baseline and at follow-up 4 weeks and 12 weeks after extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03703479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.