Alveolar OsteitisNCT04151147
Effect of CGF on Frequency of Alveolar Osteitis Following Partially Erupted Mandibular Third Molar Surgery
A study testing Concentrated Growth Factor (Test group) in people with Alveolar Osteitis and Impacted Tooth, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective study was to assess the effectiveness of concentrated growth factors (CGFs) in preventing the development of alveolar osteitis (AO) after the extraction of partially-erupted mandibular third molars. This study was designed as a randomized controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Osteitis, Impacted Tooth
- What is being tested?
- Concentrated Growth Factor (Test group)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2018to 30 Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients Age ≥ 18 years of age
- Willing and able to provide informed consent
- Ability to cooperate with the requirements of the study protocol
- Healthy patients without medical diseases or a history of bleeding problems
- Patients with the need of extraction of third molars
- The third molars had to be symmetrical, partially-erupted and in the Class I, Level B according to Pell \& Gregory classification and in the vertical angulations according to Winter's classification.
Who cannot join
- Patients who have pre-existing abscess or cellulitis, acute pericoronitis, or pre-existing conditions such as an odontogenic cyst or tumour associated with their third molars
- Patients who were pregnant and breastfeeding
- Patients with drug usage such as bisphosphonate, steroids and antidepressants
- Patients who had a smoking habit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Concentrated Growth Factors on Frequency of Alveolar Osteitis Following Partially Erupted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Study
The aim of this prospective study was to assess the effectiveness of concentrated growth factors (CGFs) in preventing the development of alveolar osteitis (AO) after the extraction of partially-erupted mandibular third molars.
This study was designed as a randomized controlled clinical trial. In each case, one socket received CGFs and the other served as a control. The predictor variable was the CGFs application and the sides were categorized as 'CGFs' and 'non-CGFs'. The outcome variable was the development of AO during the first postoperative week. Also, demographic variable included age and gender was noted.
Read the detailed description
The investigators designed and implemented a randomized single-blind clinical trial.Randomization was performed by simple coin toss to select the side of CGFs fibrin gel placement before the commencement of third molar surgery. In this way, the sides in each patient were randomly divided into 2 study groups:
Group I (test) - with CGFs placed in the extraction socket Group II (control) - without CGFs placement All operations were performed under local anesthesia by the same surgeon. An envelope flap was raised to provide access. Bone removal was done with the help of stainless steel burs. Constant irrigation with saline was used while removing bone to prevent thermal necrosis. Third molar was luxated with the help of straight elevator and then extracted with the help of third molar forceps. After extraction, any remains of the dental follicle were removed and the extraction sockets were irrigated with 60 mL of sterile saline. To prevent the flap laceration, bone contouring was also performed under sterile saline irrigation. CGFs fibrin gel was then randomly placed into one socket and the opposite side was considered as the control. Finally, wound closure was completed with silk suture.
The primary outcome variable was AO, classified as present or absent.It is characterized by postoperative pain in and around the extraction side, which increases in severity within first week after the extraction, accompanied by a partially or totally disintegrated blood clot within the alveolar socket, with or without halitosis. Other defining symptoms that have been reported in the literature are radiating pain towards the temporal region and ear, inflamed gingival margin, ipsilateral regional lymphadenopathy and, less commonly, low-grade fever.
- Conditions
- Alveolar Osteitis, Impacted Tooth
- Being tested
- Concentrated Growth Factor (Test group), Non-Concentrated Growth Factor (Control group)
- Keywords
- Third molar surgery, Alveolar osteitis, Platelet concentrates
- Medical subject headings
- Dry Socket, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated Growth Factor (Test group)Procedure or surgery
The patients' blood was collected in 9 ml glass tubes and immediately centrifuged to prevent coagulation in special centrifuge device. The CGF program was set up as follows: accelerated for 30 seconds so as to reach 2700 rpm, rotated for 2 minutes, then reduced to 2400 rpm, then rotated again for 4 minutes and accelerated to 2700 rpm, rotated for 4 minutes, then accelerated to 3000 rpm for 3 minutes, and decelerated for 36 seconds to stop. The middle layer in the tube was separated by the ''Buffy coat'' containing the CGFs fibrin gel using forceps and scissor. Then, this fibrin gel was inserted in the extraction cavity.
Non-Concentrated Growth Factor (Control group)Procedure or surgery
Third molar extraction was performed under local anesthesia. Following the extraction, the socket was sutured and natural healing process was observed. This side was considered as a control group.
| Study group | Role | What they receive |
|---|---|---|
| CGF application in the extraction socket | Experimental | Partially impacted third molar was extracted with the help of straight elevator and third molar forceps. After extraction, any remains of the dental follicle were removed and the extraction sockets were irrigated with 60 mL of sterile saline. CGF fibrin gel was then randomly placed into one socket and wound closure was completed with silk suture. Receives: Procedure: Concentrated Growth Factor (Test group) |
| non-CGF application in the extraction socket | Experimental | Opposite side of the patient was considered as the control. After extraction of the third molar, dental follicle were removed and to prevent the flap laceration, bone contouring was also performed under sterile saline irrigation. Finally, wound closure was completed with silk suture. Receives: Procedure: Non-Concentrated Growth Factor (Control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of alveolar osteitis formation
Clinical data was collected with regard to alveolar osteitis formation on the 3rd and 7th days after surgery with the following characteristics: 1) progressive and severe pain in and around the extraction side within first week; 2) partially or totally loss of blood clot and exposure of the alveolar bone with or without halitosis. Patients who met one of the criterias, were taken to be alveolar osteitis.
Measured: Change of alveolar osteitis formation at 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start2 Jan 2018
- Primary completion15 Jul 2018
- Study completion30 Jul 2018
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 Alveolar OsteitisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Işık, Ege University
- Investigators
- Banu Özveri Koyuncu, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151147
- Sponsor's protocol ID
- Oral Surgery
- Status last verified
- Nov 2019
- First submitted
- 30 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozveri Koyuncu B, Isik G, Ozden Yuce M, Gunbay S, Gunbay T. Effect of concentrated growth factors on frequency of alveolar Osteitis following partially-erupted mandibular third molar surgery: a randomized controlled clinical study. BMC Oral Health. 2020 Aug 17;20(1):222. doi: 10.1186/s12903-020-01210-7.
PubMed 32807173
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Concentrated Growth Factors on Frequency of Alveolar Osteitis Following Partially Erupted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04151147
- Acronym / sponsor ID
- Oral Surgery
- Conditions
- Alveolar Osteitis, Impacted Tooth
- Keywords
- Third molar surgery, Alveolar osteitis, Platelet concentrates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 5 Nov 2019 (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 prospective study was to assess the effectiveness of concentrated growth factors (CGFs) in preventing the development of alveolar osteitis (AO) after the extraction of partially-erupted mandibular third molars.
This study was designed as a randomized controlled clinical trial. In each case, one socket received CGFs and the other served as a control. The predictor variable was the CGFs application and the sides were categorized as 'CGFs' and 'non-CGFs'. The outcome variable was the development of AO during the first postoperative week. Also, demographic variable included age and gender was noted.
Detailed description
The investigators designed and implemented a randomized single-blind clinical trial.Randomization was performed by simple coin toss to select the side of CGFs fibrin gel placement before the commencement of third molar surgery. In this way, the sides in each patient were randomly divided into 2 study groups:
Group I (test) - with CGFs placed in the extraction socket Group II (control) - without CGFs placement All operations were performed under local anesthesia by the same surgeon. An envelope flap was raised to provide access. Bone removal was done with the help of stainless steel burs. Constant irrigation with saline was used while removing bone to prevent thermal necrosis. Third molar was luxated with the help of straight elevator and then extracted with the help of third molar forceps. After extraction, any remains of the dental follicle were removed and the extraction sockets were irrigated with 60 mL of sterile saline. To prevent the flap laceration, bone contouring was also performed under sterile saline irrigation. CGFs fibrin gel was then randomly placed into one socket and the opposite side was considered as the control. Finally, wound closure was completed with silk suture.
The primary outcome variable was AO, classified as present or absent.It is characterized by postoperative pain in and around the extraction side, which increases in severity within first week after the extraction, accompanied by a partially or totally disintegrated blood clot within the alveolar socket, with or without halitosis. Other defining symptoms that have been reported in the literature are radiating pain towards the temporal region and ear, inflamed gingival margin, ipsilateral regional lymphadenopathy and, less commonly, low-grade fever.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGF application in the extraction socket | Experimental | Procedure: Concentrated Growth Factor (Test group)Partially impacted third molar was extracted with the help of straight elevator and third molar forceps. After extraction, any remains of the dental follicle were removed and the extraction sockets were irrigated with 60 mL of sterile saline. CGF fibrin gel was then randomly placed into one socket and wound closure was completed with silk suture. |
| non-CGF application in the extraction socket | Experimental | Procedure: Non-Concentrated Growth Factor (Control group)Opposite side of the patient was considered as the control. After extraction of the third molar, dental follicle were removed and to prevent the flap laceration, bone contouring was also performed under sterile saline irrigation. Finally, wound closure was completed with silk suture. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients Age ≥ 18 years of age
- Willing and able to provide informed consent
- Ability to cooperate with the requirements of the study protocol
- Healthy patients without medical diseases or a history of bleeding problems
- Patients with the need of extraction of third molars
Key exclusion criteria (4 listed)
- Patients who have pre-existing abscess or cellulitis, acute pericoronitis, or pre-existing conditions such as an odontogenic cyst or tumour associated with their third molars
- Patients who were pregnant and breastfeeding
- Patients with drug usage such as bisphosphonate, steroids and antidepressants
- Patients who had a smoking habit
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 Factor (Test group)The patients' blood was collected in 9 ml glass tubes and immediately centrifuged to prevent coagulation in special centrifuge device. The CGF program was set up as follows: accelerated for 30 seconds so as to reach 2700 rpm, rotated for 2 minutes, then reduced to 2400 rpm, then rotated again for 4 minutes and accelerated to 2700 rpm, rotated for 4 minutes, then accelerated to 3000 rpm for 3 minutes, and decelerated for 36 seconds to stop. The middle layer in the tube was separated by the ''Buffy coat'' containing the CGFs fibrin gel using forceps and scissor. Then, this fibrin gel was inserted in the extraction cavity. | Procedure or surgery | CGF application in the extraction socket |
| Non-Concentrated Growth Factor (Control group)Third molar extraction was performed under local anesthesia. Following the extraction, the socket was sutured and natural healing process was observed. This side was considered as a control group. | Procedure or surgery | non-CGF application in the extraction socket |
Primary outcome
Presence of alveolar osteitis formation
Time frame: Change of alveolar osteitis formation at 7 days.
Clinical data was collected with regard to alveolar osteitis formation on the 3rd and 7th days after surgery with the following characteristics: 1) progressive and severe pain in and around the extraction side within first week; 2) partially or totally loss of blood clot and exposure of the alveolar bone with or without halitosis. Patients who met one of the criterias, were taken to be alveolar osteitis.
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 5 Nov 2019.
- Derived from this study: PubMed 32807173Ozveri Koyuncu B, Isik G, Ozden Yuce M, Gunbay S, Gunbay T. Effect of concentrated growth factors on frequency of alveolar Osteitis following partially-erupted mandibular third molar surgery: a randomized controlled clinical study. BMC Oral Health. 2020 Aug 17;20(1):222. doi: 10.1186/s12903-020-01210-7.
- Individual participant dataSharing planned: No
Related trials for Alveolar Osteitis
Recruiting
Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction
Wound Healing, Alveolitis of Jaw
Not yet recruiting
Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis
Alveolar Osteitis
Not yet recruiting
Effectiveness of Telephonic and Digital Postoperative Follow-up Communication Strategies on Patient Compliance, Clinical Recovery, and Quality of Life After Dental Extraction
Tooth Extraction, Postoperative Care
RecruitingObservational study
PERIodontal Disease, Microbiota and Miscarriage
Miscarriage, Parodontitis
Active, not recruitingEarly Phase 1
Ozone Oil-based Gel and CHX Gel After Lower Third Molar Removal
Pain, Dry Socket
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.
Banu Özveri Koyuncu study director
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 (Test group) in people with Alveolar Osteitis and Impacted Tooth, 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 6 inclusion and 4 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 5 Nov 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 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?
Presence of alveolar osteitis formation (time frame: Change of alveolar osteitis formation at 7 days.). 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 NCT04151147, 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 5 Nov 2019.