Impacted Wisdom ToothNCT05678296
Investigation of Effectiveness of Local Antibiotic With Platelet Rich Fibrin on Third Molar Surgery Outcomes In Vivo
An observational study of Impacted Wisdom Tooth and Pain, run by Ceren Melahat Donmezer at 1 site in Cyprus.
Trial summary
The aim of this study was investigate the effectiveness of Local Antibiotic Applications With Platelet Rich Fibrin on Third Molar Surgery Outcomes In Vivo and In Vitro. The study included a total of 60 patients with impacted mandibular third molar. Patients were evaluated in 3 randomly separated groups. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Impacted Wisdom Tooth, Pain, Staphylococcus Aureus
- What is being tested?
- Diagnosis, Analgesic and traditional osteotomies
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCyprus
- Study dates
- 20 Apr 2020to 23 Apr 2022
- 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: The patients with no systemic diseases aged between 19-45
Who may be able to join
- patient with no systemic diseases, no current infection, no smoke, no pregnancy
Who cannot join
- no inflammation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Effectiveness of Local Antibiotic Applications With Platelet Rich Fibrin on Third Molar Surgery Outcomes In Vivo and In Vitro
The aim of this study was investigate the effectiveness of Local Antibiotic Applications With Platelet Rich Fibrin on Third Molar Surgery Outcomes In Vivo and In Vitro. The study included a total of 60 patients with impacted mandibular third molar. Patients were evaluated in 3 randomly separated groups. For the first and second group, Platelets Rich Fibrin+ local antibiotics were applied into the tooth socket. For the first group, amoxicillin was applied and for the second group, clindamycin was applied. 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, Pain, Staphylococcus Aureus
- Being tested
- Diagnosis, Analgesic, traditional osteotomies, Platelet Rich Fibrin, Antibiotic
- Keywords
- local antibiotic, comparison, platelets rich fibrin
- Medical subject headings
- Pain, Staphylococcal Infections
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.
AnalgesicDrug
Analgesics are prescribed for the patients for all groups.
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.
AntibioticDrug
no systemic antibiotics are prescribed for the patients for all groups.
| Study group | Role | What they receive |
|---|---|---|
| control group | platelet-rich fibrin placed into the socket of extracted tooth and no antibiotic is prescribed. Receives: Diagnostic Test: Diagnosis; Drug: Analgesic; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin | |
| group 1 | platelet-rich fibrin + 0.5 ml amoklavin I.V. 1.2 gr placed into the socket of the extracted tooth. Receives: Diagnostic Test: Diagnosis; Drug: Analgesic; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Antibiotic | |
| group 2 | 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; Drug: Analgesic; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Antibiotic |
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
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start20 Apr 2020
- Primary completion17 Feb 2022
- Study completion23 Apr 2022
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
- 60 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
- NCT05678296
- Sponsor's protocol ID
- 67-774-2019
- Status last verified
- Jan 2023
- First submitted
- 28 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donmezer CM, Bilginaylar K. Comparison of the Postoperative Effects of Local Antibiotic versus Systemic Antibiotic with the Use of Platelet-Rich Fibrin on Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Study. Biomed Res Int. 2021 Dec 2;2021:3040661. doi: 10.1155/2021/3040661. eCollection 2021.
PubMed 34901267Caymaz MG, Uyanik LO. Comparison of the effect of advanced platelet-rich fibrin and leukocyte- and platelet-rich fibrin on outcomes after removal of impacted mandibular third molar: A randomized split-mouth study. Niger J Clin Pract. 2019 Apr;22(4):546-552. doi: 10.4103/njcp.njcp_473_18.
PubMed 30975961Polak 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 30629300Uyanik 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 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Effectiveness of Local Antibiotic Applications With Platelet Rich Fibrin on Third Molar Surgery Outcomes In Vivo and In Vitro
- ClinicalTrials.gov ID
- NCT05678296
- Acronym / sponsor ID
- 67-774-2019
- Conditions
- Impacted Wisdom Tooth, Pain, Staphylococcus Aureus
- Keywords
- local antibiotic, comparison, platelets rich fibrin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ceren Melahat DonmezerUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 23 Apr 2022 (actual)
- First posted
- 10 Jan 2023 (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 effectiveness of Local Antibiotic Applications With Platelet Rich Fibrin on Third Molar Surgery Outcomes In Vivo and In Vitro. The study included a total of 60 patients with impacted mandibular third molar. Patients were evaluated in 3 randomly separated groups. For the first and second group, Platelets Rich Fibrin+ local antibiotics were applied into the tooth socket. For the first group, amoxicillin was applied and for the second group, clindamycin was applied. 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
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | – | Diagnostic Test: Diagnosis, Drug: Analgesic, Procedure: traditional osteotomies, Biological: Platelet Rich Fibrinplatelet-rich fibrin placed into the socket of extracted tooth and no antibiotic is prescribed. |
| group 1 | – | Diagnostic Test: Diagnosis, Drug: Analgesic, Procedure: traditional osteotomies, Biological: Platelet Rich Fibrin, Drug: Antibioticplatelet-rich fibrin + 0.5 ml amoklavin I.V. 1.2 gr placed into the socket of the extracted tooth. |
| group 2 | – | Diagnostic Test: Diagnosis, Drug: Analgesic, Procedure: traditional osteotomies, Biological: Platelet Rich Fibrin, 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients with no systemic diseases aged between 19-45
Key inclusion criteria (1 listed)
- patient with no systemic diseases, no current infection, no smoke, no pregnancy
Key exclusion criteria (1 listed)
- 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 |
| AnalgesicAnalgesics are prescribed for the patients for all groups. | Drug | control group, group 1, group 2 |
| 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 |
| 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 |
| Antibioticno systemic antibiotics are prescribed for the patients for all groups. | Drug | group 1, group 2 |
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.
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.
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.
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 11 Jan 2023.
- Results publication: PubMed 34901267Donmezer CM, Bilginaylar K. Comparison of the Postoperative Effects of Local Antibiotic versus Systemic Antibiotic with the Use of Platelet-Rich Fibrin on Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Study. Biomed Res Int. 2021 Dec 2;2021:3040661. doi: 10.1155/2021/3040661. eCollection 2021.
- Results publication: PubMed 30975961Caymaz MG, Uyanik LO. Comparison of the effect of advanced platelet-rich fibrin and leukocyte- and platelet-rich fibrin on outcomes after removal of impacted mandibular third molar: A randomized split-mouth study. Niger J Clin Pract. 2019 Apr;22(4):546-552. doi: 10.4103/njcp.njcp_473_18.
- Results publication: 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.
- Results publication: 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 and Pain, 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 11 Jan 2023. 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 NCT05678296, 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 11 Jan 2023.