Oral ComplicationNCT06893523
Effect of CGF on Postoperative Edema in Third Molar Surgery
A study testing Concentrated Growth Factor and Non-CGF in people with Oral Complication, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the effects of concentrated growth factor (CGF) on edema after bilateral impacted third molar surgery and to determine its contribution to the healing process. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Complication
- What is being tested?
- Concentrated Growth Factor and Non-CGF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2017to 5 Jun 2018
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with bilateral, symmetrical, bone-retained (vertical, mesioangular, horizontal) impacted wisdom teeth in the mandible, regardless of gender
- Patients without any systemic disease
- Patients who have been informed about the duration, purpose and requirements of the study and who have signed the informed consent form voluntarily.-
Who cannot join
- Having a disease affecting general health that requires the application of prophylactic antimicrobial agents
- Having a systemic viral, fungal or bacterial infection
- Patients with acute or chronic maxillary sinusitis
- Suspected or diagnosed pregnancy and nursing mothers
- Patients with heart and vascular diseases
- Patients with liver disease, haematological disease and neoplastic disease
Show all 12Show fewer
- Patients who have recently received anti-inflammatory therapy
- Patients with chronic medication use (antihistamines, NSAIDs, steroids and antidepressants)
- Patients predisposed to psychotic or psychopathic tendencies
- Patients with rheumatic diseases, blood diseases, diabetes mellitus
- Patients at cardiological risk of infective endocarditis
- Patients under antibiotic pressure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Dentistry
Izmir, Bornova, 35040
About this study
Official title: Evaluation of the Effect of Concentrated Growth Factor (CGF) on Postoperative Edema in Bilateral Impacted Third Molar Surgery: A Randomized Controlled Clinical Study
The purpose of this study is to evaluate the effects of concentrated growth factor (CGF) on edema after bilateral impacted third molar surgery and to determine its contribution to the healing process.
The main question it aims to answer is:
Is CGF effective on reducing the edema in impacted third molar surgery? Researchers compare the edema amount on the CGF-applied and CGF free sides after impacted third molar surgery. The edema measurements are performed on the second and seventh days.
Read the detailed description
It has been observed that the treatment of impacted tooth extraction, which is the most commonly performed interventional procedure in oral and maxillofacial surgery clinics and affects the patient's comfort and daily life after the operation, has been investigated in many ways and new ideas are constantly emerging. Wound healing is a process controlled by many intracellular and extracellular mechanisms. In recent years, many studies have been conducted to make this process faster and more successful, and it has been observed that the use of platelet products in this area has yielded extremely successful results. Concentrated Growth Factor (CGF), which has gained an important place in regenerative medicine in recent years, has attracted attention due to its potential to minimize postoperative complications.
This randomized clinical trial was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ege University.
Forty-nine patients, regardless of gender, with bilateral, symmetrical, bone-retained (vertical, mesioangular, horizontal) impacted third molar in the mandible and without any systemic disease are included in the study. Before the impacted third molar surgery, detailed medical and dental history are taken from the patients.
The patients are informed in detail about the drugs to be used in the study, the applied method, the duration and purpose of the study.
In order to obtain the data required for statistical analysis of the amount of edema on the sides where CGF is used and not used after the operation, edema measurements are made at three points on the patients before the operation, on the 2nd and 7th days after the operation.
These measurements are made between the external canthus-angulus mandible, tragus-commissura and tragus-pogonium.
Wilcoxon Signed Ranks test is used to compare the means of two dependent samples and to determine the significance of the difference between them.
- Conditions
- Oral Complication
- Being tested
- Concentrated Growth Factor, Non-CGF
- Keywords
- Edema, Third molar
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated Growth FactorOther
Bilaterally impacted third molar of the patients areremoved surgically and concentrated growth factor isplaced in one of the extraction sockets.
Non-CGFOther
The other extraction socket is left empty for control purposes.
| Study group | Role | What they receive |
|---|---|---|
| CGF | Experimental | Participants received CGF after the operation on one side Receives: Other: Concentrated Growth Factor; Other: Non-CGF |
| non-CGF | No intervention | The other extraction socket is left empty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative edema amounts on CGF-applied and CGF free sides in bilateral impacted third molar surgery
Edema measurements are made at three points on the patients before the operation, on the 2nd and 7th days after the operation. These measurements are made between the external canthus-angulus mandible, tragus-commissura and tragus-pogonium. In order to ensure standardization, all measurements are made by the same physician with the patient's head position in the same direction.
Measured: Before operation to the end of the operation at seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 May 2017
- Primary completion1 Jan 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral ComplicationStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mert Zeytinoğlu, Ege University
- Investigators
- Mert Zeytinoglu, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893523
- Sponsor's protocol ID
- EGE-DHF-MZ-001
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Concentrated Growth Factor (CGF) on Postoperative Edema in Bilateral Impacted Third Molar Surgery: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06893523
- Acronym / sponsor ID
- EGE-DHF-MZ-001
- Conditions
- Oral Complication
- Keywords
- Edema, Third molar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 25 Mar 2025 (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 purpose of this study is to evaluate the effects of concentrated growth factor (CGF) on edema after bilateral impacted third molar surgery and to determine its contribution to the healing process.
The main question it aims to answer is:
Is CGF effective on reducing the edema in impacted third molar surgery? Researchers compare the edema amount on the CGF-applied and CGF free sides after impacted third molar surgery. The edema measurements are performed on the second and seventh days.
Detailed description
It has been observed that the treatment of impacted tooth extraction, which is the most commonly performed interventional procedure in oral and maxillofacial surgery clinics and affects the patient's comfort and daily life after the operation, has been investigated in many ways and new ideas are constantly emerging. Wound healing is a process controlled by many intracellular and extracellular mechanisms. In recent years, many studies have been conducted to make this process faster and more successful, and it has been observed that the use of platelet products in this area has yielded extremely successful results. Concentrated Growth Factor (CGF), which has gained an important place in regenerative medicine in recent years, has attracted attention due to its potential to minimize postoperative complications.
This randomized clinical trial was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ege University.
Forty-nine patients, regardless of gender, with bilateral, symmetrical, bone-retained (vertical, mesioangular, horizontal) impacted third molar in the mandible and without any systemic disease are included in the study. Before the impacted third molar surgery, detailed medical and dental history are taken from the patients.
The patients are informed in detail about the drugs to be used in the study, the applied method, the duration and purpose of the study.
In order to obtain the data required for statistical analysis of the amount of edema on the sides where CGF is used and not used after the operation, edema measurements are made at three points on the patients before the operation, on the 2nd and 7th days after the operation.
These measurements are made between the external canthus-angulus mandible, tragus-commissura and tragus-pogonium.
Wilcoxon Signed Ranks test is used to compare the means of two dependent samples and to determine the significance of the difference between them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGF | Experimental | Other: Concentrated Growth Factor, Other: Non-CGFParticipants received CGF after the operation on one side |
| non-CGF | No intervention | –The other extraction socket is left empty |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with bilateral, symmetrical, bone-retained (vertical, mesioangular, horizontal) impacted wisdom teeth in the mandible, regardless of gender
- Patients without any systemic disease
- Patients who have been informed about the duration, purpose and requirements of the study and who have signed the informed consent form voluntarily.-
Key exclusion criteria (12 listed)
- Having a disease affecting general health that requires the application of prophylactic antimicrobial agents
- Having a systemic viral, fungal or bacterial infection
- Patients with acute or chronic maxillary sinusitis
- Suspected or diagnosed pregnancy and nursing mothers
- Patients with heart and vascular diseases
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 |
|---|---|---|
| Concentrated Growth FactorBilaterally impacted third molar of the patients areremoved surgically and concentrated growth factor isplaced in one of the extraction sockets. | Other | CGF |
| Non-CGFThe other extraction socket is left empty for control purposes. | Other | CGF |
Primary outcome
Postoperative edema amounts on CGF-applied and CGF free sides in bilateral impacted third molar surgery
Time frame: Before operation to the end of the operation at seven days
Edema measurements are made at three points on the patients before the operation, on the 2nd and 7th days after the operation. These measurements are made between the external canthus-angulus mandible, tragus-commissura and tragus-pogonium. In order to ensure standardization, all measurements are made by the same physician with the patient's head position in the same direction.
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 25 Mar 2025.
- 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.
Mert Zeytinoglu principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated Growth Factor and Non-CGF in people with Oral Complication, run by Ege University at 1 site in Turkey (Türkiye).
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 3 inclusion and 12 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 25 Mar 2025. 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 Turkey (Türkiye). 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?
Postoperative edema amounts on CGF-applied and CGF free sides in bilateral impacted third molar surgery (time frame: Before operation to the end of the operation at seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2025.