Impacted Wisdom ToothNCT04989127
Comparison The Postoperative Effects of Local and Systemic Antibiotics Applied With Platelets Rich Fibrin
An observational study of Impacted Wisdom Tooth, run by Ceren Melahat Donmezer at 1 site in Cyprus.
Trial summary
The aim of this study was investigate the comparison of postoperative effects of local antibiotics mixed with platelet-rich fibrin and postoperative systemic antibiotic applications prescribed for mandibular impacted third molar tooth extraction. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Impacted Wisdom Tooth
- What is being tested?
- Diagnosis, traditional osteotomies and Platelet Rich Fibrin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteCyprus
- Study dates
- 17 Mar 2019to 21 Feb 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: community aged between 18-40 without any important systemic disease.
Who may be able to join
- The patient had no systemic diseases, no taken opioids for a long period, no current infections or acute pericoronitis, no smoke or drink alcohol, no pregnancy, the absence of allergy to penicillin and presence of penicillin allergy.
Who cannot join
- pericoronitis, no inflammation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison The Postoperative Effects Of Local Antibiotic Versus Systemic Antibiotic With The Use Of Platelet Rich Fibrin On The Mandibular Third Molar Surgery
The aim of this study was investigate the comparison of postoperative effects of local antibiotics mixed with platelet-rich fibrin and postoperative systemic antibiotic applications prescribed for mandibular impacted third molar tooth extraction. The study included a total of 75 patients with impacted mandibular third molar. Patients were evaluated in 5 randomly separated groups. For the first and third group, Platelets Rich Fibrin+ systemic Antibiotics were applied into the tooth socket and for the second and fourth group, Platelets Rich Fibrin + local antibiotics were applied, respectively. There was a control group which only Platelets Rich Fibrin was applied into the socket. The outcome variables were pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed based on first, second, third, and seventh days following the operation.
- Conditions
- Impacted Wisdom Tooth
- Being tested
- Diagnosis, traditional osteotomies, Platelet Rich Fibrin, Antibiotics, Penicillin, Analgesic
- Keywords
- platelets rich fibrin, systemic antibiotic, local antibiotic, comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosisDiagnostic test
All of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant.
traditional osteotomiesProcedure or surgery
In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).
Platelet Rich FibrinBiological
Platelet rich fibrin (PRF), is an example and popular procedure for accelerate healing of soft and hard tissue because of the presence of various growth factors.a blood sample was taken without anticoagulant in 10 mL glass-coated plastic tubes that were immediately centrifuged (Elektro-mag M415P) at 3,000 rpm for 10 min (approximately 400 g) (13). The platelet-poor plasma that accumulated at the top of the tubes was discarded.PRF was dissected approximately 2 mm below its contact point with the red corpuscles situated beneath, to include any remaining platelets that may have localized below the junction between the PRF and red corpuscles.
Antibiotics, PenicillinDrug
Antibiotics are prescribed for the patients.
AnalgesicDrug
Analgesics are prescribed for the patients.
AntibioticDrug
Patients with penicillin allergy
| Study group | Role | What they receive |
|---|---|---|
| group 1 | platelet-rich fibrin placed into the socket of the extracted tooth.+ Augmentin 1 gr tablet prescribed 3 times a day Receives: Diagnostic Test: Diagnosis; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Antibiotics, Penicillin; Drug: Analgesic | |
| group 2 | platelet-rich fibrin + 0.5 ml amoklavin I.V. 1.2 gr placed into the socket of the extracted tooth. Receives: Diagnostic Test: Diagnosis; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Antibiotics, Penicillin; Drug: Analgesic | |
| group 3 | platelet-rich fibrin placed into the socket of extracted tooth + Clin 150 mg capsule prescribed 4 times a day Receives: Diagnostic Test: Diagnosis; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Analgesic; Drug: Antibiotic | |
| group 4 | platelet-rich fibrin + 0.5 ml Clin 600 mg/4 ml IM/IV, 0.5 ml placed into the socket of the extracted tooth. Receives: Diagnostic Test: Diagnosis; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Analgesic; Drug: Antibiotic | |
| control group | platelet-rich fibrin placed into the socket of extracted tooth and no antibiotic is prescribed. Receives: Diagnostic Test: Diagnosis; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Analgesic |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS)
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Measured: day 1
visual analogue scale (VAS)
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Measured: day 2
visual analogue scale (VAS)
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Measured: day 3
visual analogue scale (VAS)
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Measured: day 7
visual analogue scale (VAS)
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Measured: day 15
Trismus
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Measured: day 1
Trismus
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Measured: day 2
Trismus
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Measured: day 3
Trismus
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Measured: day 7
Trismus
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Measured: day 15
swelling
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
Measured: day 1
swelling
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
Measured: day 2
swelling
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
Measured: day 3
swelling
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
Measured: day 7
swelling
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
Measured: day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start17 Mar 2019
- Primary completion20 Feb 2021
- Study completion21 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Impacted Wisdom ToothStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceren Melahat Donmezer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ceren Melahat Donmezer, Near East University, Turkey
- Investigators
- Ceren Melahat Dönmezer, Principal investigator, Near East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989127
- Sponsor's protocol ID
- YDU/2019/67-774
- Status last verified
- Mar 2024
- First submitted
- 1 Jul 2021
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polak D, Clemer-Shamai N, Shapira L. Incorporating antibiotics into platelet-rich fibrin: A novel antibiotics slow-release biological device. J Clin Periodontol. 2019 Feb;46(2):241-247. doi: 10.1111/jcpe.13063.
PubMed 30629300Osunde OD, Adebola RA, Omeje UK. Management of inflammatory complications in third molar surgery: a review of the literature. Afr Health Sci. 2011 Sep;11(3):530-7.
PubMed 22275950Kreutzer K, Storck K, Weitz J. Current evidence regarding prophylactic antibiotics in head and neck and maxillofacial surgery. Biomed Res Int. 2014;2014:879437. doi: 10.1155/2014/879437. Epub 2014 Jul 8.
PubMed 25110703Uyanik LO, Bilginaylar K, Etikan I. Effects of platelet-rich fibrin and piezosurgery on impacted mandibular third molar surgery outcomes. Head Face Med. 2015 Jul 26;11:25. doi: 10.1186/s13005-015-0081-x.
PubMed 26209242
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison The Postoperative Effects Of Local Antibiotic Versus Systemic Antibiotic With The Use Of Platelet Rich Fibrin On The Mandibular Third Molar Surgery
- ClinicalTrials.gov ID
- NCT04989127
- Acronym / sponsor ID
- YDU/2019/67-774
- Conditions
- Impacted Wisdom Tooth
- Keywords
- platelets rich fibrin, systemic antibiotic, local antibiotic, comparison
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ceren Melahat DonmezerUniversity, hospital or other
- Study start
- 17 Mar 2019 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 21 Feb 2021 (actual)
- First posted
- 4 Aug 2021 (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.
The aim of this study was investigate the comparison of postoperative effects of local antibiotics mixed with platelet-rich fibrin and postoperative systemic antibiotic applications prescribed for mandibular impacted third molar tooth extraction. The study included a total of 75 patients with impacted mandibular third molar. Patients were evaluated in 5 randomly separated groups. For the first and third group, Platelets Rich Fibrin+ systemic Antibiotics were applied into the tooth socket and for the second and fourth group, Platelets Rich Fibrin + local antibiotics were applied, respectively. There was a control group which only Platelets Rich Fibrin was applied into the socket. The outcome variables were pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed based on first, second, third, and seventh days following the operation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Diagnostic Test: Diagnosis, Procedure: traditional osteotomies, Biological: Platelet Rich Fibrin, Drug: Antibiotics, Penicillin, Drug: Analgesicplatelet-rich fibrin placed into the socket of the extracted tooth.+ Augmentin 1 gr tablet prescribed 3 times a day |
| group 2 | – | Diagnostic Test: Diagnosis, Procedure: traditional osteotomies, Biological: Platelet Rich Fibrin, Drug: Antibiotics, Penicillin, Drug: Analgesicplatelet-rich fibrin + 0.5 ml amoklavin I.V. 1.2 gr placed into the socket of the extracted tooth. |
| group 3 | – | Diagnostic Test: Diagnosis, Procedure: traditional osteotomies, Biological: Platelet Rich Fibrin, Drug: Analgesic, Drug: Antibioticplatelet-rich fibrin placed into the socket of extracted tooth + Clin 150 mg capsule prescribed 4 times a day |
| group 4 | – | Diagnostic Test: Diagnosis, Procedure: traditional osteotomies, Biological: Platelet Rich Fibrin, Drug: Analgesic, Drug: Antibioticplatelet-rich fibrin + 0.5 ml Clin 600 mg/4 ml IM/IV, 0.5 ml placed into the socket of the extracted tooth. |
| control group | – | Diagnostic Test: Diagnosis, Procedure: traditional osteotomies, Biological: Platelet Rich Fibrin, Drug: Analgesicplatelet-rich fibrin placed into the socket of extracted tooth and no antibiotic is prescribed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- community aged between 18-40 without any important systemic disease.
Key inclusion criteria (1 listed)
- The patient had no systemic diseases, no taken opioids for a long period, no current infections or acute pericoronitis, no smoke or drink alcohol, no pregnancy, the absence of allergy to penicillin and presence of penicillin allergy.
Key exclusion criteria (1 listed)
- pericoronitis, no inflammation
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 |
|---|---|---|
| DiagnosisAll of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant. | Diagnostic test | control group, group 1, group 2, group 3, group 4 |
| traditional osteotomiesIn all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap). | Procedure or surgery | control group, group 1, group 2, group 3, group 4 |
| Platelet Rich FibrinPlatelet rich fibrin (PRF), is an example and popular procedure for accelerate healing of soft and hard tissue because of the presence of various growth factors.a blood sample was taken without anticoagulant in 10 mL glass-coated plastic tubes that were immediately centrifuged (Elektro-mag M415P) at 3,000 rpm for 10 min (approximately 400 g) (13). The platelet-poor plasma that accumulated at the top of the tubes was discarded.PRF was dissected approximately 2 mm below its contact point with the red corpuscles situated beneath, to include any remaining platelets that may have localized below the junction between the PRF and red corpuscles. | Biological | control group, group 1, group 2, group 3, group 4 |
| Antibiotics, PenicillinAntibiotics are prescribed for the patients. | Drug | group 1, group 2 |
| AnalgesicAnalgesics are prescribed for the patients. | Drug | control group, group 1, group 2, group 3, group 4 |
| AntibioticPatients with penicillin allergy | Drug | group 3, group 4 |
Primary outcome
visual analogue scale (VAS)
Time frame: day 1
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
visual analogue scale (VAS)
Time frame: day 2
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
visual analogue scale (VAS)
Time frame: day 3
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
visual analogue scale (VAS)
Time frame: day 7
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
visual analogue scale (VAS)
Time frame: day 15
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Trismus
Time frame: day 1
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Trismus
Time frame: day 2
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Trismus
Time frame: day 3
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Trismus
Time frame: day 7
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Trismus
Time frame: day 15
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
swelling
Time frame: day 1
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
swelling
Time frame: day 2
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
swelling
Time frame: day 3
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
swelling
Time frame: day 7
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
swelling
Time frame: day 15
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
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 22 Mar 2024.
- Background: PubMed 30629300Polak D, Clemer-Shamai N, Shapira L. Incorporating antibiotics into platelet-rich fibrin: A novel antibiotics slow-release biological device. J Clin Periodontol. 2019 Feb;46(2):241-247. doi: 10.1111/jcpe.13063.
- Background: PubMed 22275950Osunde OD, Adebola RA, Omeje UK. Management of inflammatory complications in third molar surgery: a review of the literature. Afr Health Sci. 2011 Sep;11(3):530-7.
- Background: PubMed 25110703Kreutzer K, Storck K, Weitz J. Current evidence regarding prophylactic antibiotics in head and neck and maxillofacial surgery. Biomed Res Int. 2014;2014:879437. doi: 10.1155/2014/879437. Epub 2014 Jul 8.
- Background: PubMed 26209242Uyanik LO, Bilginaylar K, Etikan I. Effects of platelet-rich fibrin and piezosurgery on impacted mandibular third molar surgery outcomes. Head Face Med. 2015 Jul 26;11:25. doi: 10.1186/s13005-015-0081-x.
- Individual participant dataSharing planned: No
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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.
Ceren Melahat Dönmezer principal investigator
Near East University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impacted Wisdom Tooth, run by Ceren Melahat Donmezer at 1 site in Cyprus.
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 1 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 22 Mar 2024. 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 Cyprus. 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?
visual analogue scale (VAS) (time frame: day 1). The study lists 15 primary outcomes in all. 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 NCT04989127, which also lists 4 linked publications.
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 22 Mar 2024.