Alveolar OsteitisNCT04507009
Clinical Investigation of the Efficacy of CGF and Ozone in the Treatment of Alveolar Osteitis
A study testing Ozone, CGF and Traditional treatment in people with Alveolar Osteitis, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the efficacy of CGF and Ozone in the treatment of alveolitis and to develop a new treatment protocol that can enable a quick and effective solution of this clinical problem, which significantly affects patients' comfort of life. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Osteitis
- What is being tested?
- Ozone, CGF and Traditional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 1 Oct 2022
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have one or more of the following in addition to severe pain, which occur within and around the socket 1-3 days after extraction and do not decrease with pain killers;
- With a partially or completely disintegrated blood clot in the socket
- With exposed bone that gives a dark gray appearance
- With bad odor
Who cannot join
- Who does not want to be volunteer for the study,
- Smokers,
- During pregnancy or lactation,
- Has a chronic systemic disorder that will affect recovery,
- Has hematological disorder
- Cooperation cannot be established,
- Previously received radiotherapy or chemotherapy,
- Patients using oral contraceptives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation of the Efficacy of CGF (Concentrated Growth Factor) and Ozone in the Treatment of Alveolar Osteitis
The aim of this study is to investigate the efficacy of CGF and Ozone in the treatment of alveolitis and to develop a new treatment protocol that can enable a quick and effective solution of this clinical problem, which significantly affects patients' comfort of life.
Read the detailed description
In the present study, 60 healthy patients > 18 years old and have alveolitis, will included. 60 patient will divided randomly into three groups as Control, Ozone and Ozone+CGF. After irrigation of the sockets alvogyl, ozone and ozone+CGF will applied to the sockets respectively. Post operative pain, will measured at 1st to 7th days. Post operative infection, and granulation tissue will measured at 1st, 3rd and 7th days. Oral hygiene will evaluated at first visit. Quality of life will evaluated at 7th day.
- Conditions
- Alveolar Osteitis
- Being tested
- Ozone, CGF, Traditional treatment
- Keywords
- Alveolitis, Dry socket, Ozone, CGF
- Medical subject headings
- Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneDevice
topical gaseous ozone application
CGFOther
concentrated growth factor (CGF) application
Traditional treatmentOther
Alvogyl application
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Traditional treatment group which alvogyl applied to the socket after irrigation Receives: Other: Traditional treatment |
| Ozone | Experimental | Ozone group which Ozone (O3) applied after irrigation of the socket Receives: Device: Ozone |
| CGF +Ozone | Experimental | CGF + Ozone group which concentrated growth factor (CGF) after Ozone (O3) applied followed by irrigation of the socket. Receives: Device: Ozone; Other: CGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post-operative pain assessed: visual analog (VAS) scale
For the evaluation of the pain, the visual analog scale (VAS) will be used to express the absence of pain in the initial part on a straight line (0) and the end part to express the unbearable pain (10).
0 (no pain)--------------------------------------------------------------------------------10 (unbearable pain) Higher values of the scale represent worse outcome.
Measured: 6th and 24th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day
Secondary outcomes (3)
Granulation tissue health
Granulation tissue formation in the area after treatment will be evaluated clinically. Granulation tissue will be scored as healthy (pink color and no bleeding on probing) and unhealthy granulation tissue (dark red in color and usually bleeding on probing).
Measured: postoperative 1st, 3rd, 7th days
Inflamation severity
The severity of inflammation will be assessed using the gingival index; From values 0 to 3; 0.Normal gingiva
- Slight inflammation-slight discoloration, mild edema. no probing on bleeding,
- Moderate inflammation - redness, edema. bleeding on probing,
- Severe inflammation-marked redness and edema, ulceration and tendency to spontaneous bleeding
Measured: postoperative 1st, 3rd, 7th days
Change in the quality of postoperative life after the procedures performed
The evaluation of the change in postoperative quality of life will be done with a scale of post-operative symptom severity (PoSSe) consisting of 15-item questionnaire in which the effect of operation on eating, speech, sensation, appearance, pain, disease and daily activities is evaluated. This questionnaire was divided into subscales corresponding to seven main adverse effects, and for each possible answer there was a score ranging from 0 to a variable number. For total possible answer there was a score ranging from 0 to a 97.9. Higher values of the scale represent worse outcome.
Measured: postoperative 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Aug 2020
- Primary completion1 Aug 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar OsteitisStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Damla Torul, Ordu University
- Investigators
- Damla Torul, DDS PhD, Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507009
- Sponsor's protocol ID
- A-2005
- Status last verified
- Nov 2022
- First submitted
- 4 Aug 2020
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can share with other researchers on demand
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Efficacy of CGF (Concentrated Growth Factor) and Ozone in the Treatment of Alveolar Osteitis
- ClinicalTrials.gov ID
- NCT04507009
- Acronym / sponsor ID
- A-2005
- Conditions
- Alveolar Osteitis
- Keywords
- Alveolitis, Dry socket, Ozone, CGF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 10 Aug 2020 (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 is to investigate the efficacy of CGF and Ozone in the treatment of alveolitis and to develop a new treatment protocol that can enable a quick and effective solution of this clinical problem, which significantly affects patients' comfort of life.
Detailed description
In the present study, 60 healthy patients > 18 years old and have alveolitis, will included. 60 patient will divided randomly into three groups as Control, Ozone and Ozone+CGF. After irrigation of the sockets alvogyl, ozone and ozone+CGF will applied to the sockets respectively. Post operative pain, will measured at 1st to 7th days. Post operative infection, and granulation tissue will measured at 1st, 3rd and 7th days. Oral hygiene will evaluated at first visit. Quality of life will evaluated at 7th day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Traditional treatmentTraditional treatment group which alvogyl applied to the socket after irrigation |
| Ozone | Experimental | Device: OzoneOzone group which Ozone (O3) applied after irrigation of the socket |
| CGF +Ozone | Experimental | Device: Ozone, Other: CGFCGF + Ozone group which concentrated growth factor (CGF) after Ozone (O3) applied followed by irrigation of the socket. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have one or more of the following in addition to severe pain, which occur within and around the socket 1-3 days after extraction and do not decrease with pain killers;
- With a partially or completely disintegrated blood clot in the socket
- With exposed bone that gives a dark gray appearance
- With bad odor
Key exclusion criteria (8 listed)
- Who does not want to be volunteer for the study,
- Smokers,
- During pregnancy or lactation,
- Has a chronic systemic disorder that will affect recovery,
- Has hematological disorder
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 |
|---|---|---|
| Ozonetopical gaseous ozone application | Device | CGF +Ozone, Ozone |
| CGFconcentrated growth factor (CGF) application | Other | CGF +Ozone |
| Traditional treatmentAlvogyl application | Other | Control |
Primary outcome
Change in post-operative pain assessed: visual analog (VAS) scale
Time frame: 6th and 24th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day
For the evaluation of the pain, the visual analog scale (VAS) will be used to express the absence of pain in the initial part on a straight line (0) and the end part to express the unbearable pain (10). 0 (no pain)--------------------------------------------------------------------------------10 (unbearable pain) Higher values of the scale represent worse outcome.
3 secondary outcomes
Granulation tissue health
Time frame: postoperative 1st, 3rd, 7th days
Inflamation severity
Time frame: postoperative 1st, 3rd, 7th days
Change in the quality of postoperative life after the procedures performed
Time frame: postoperative 7th day
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 9 Nov 2022.
- Individual participant dataSharing planned: No. IPD can share with other researchers on demand
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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.
Damla Torul, DDS PhD principal investigator
Ordu 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 Ozone, CGF and Traditional treatment in people with Alveolar Osteitis, run by Ordu 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 4 inclusion and 8 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 9 Nov 2022. 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?
Change in post-operative pain assessed: visual analog (VAS) scale (time frame: 6th and 24th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day). 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 9 Nov 2022.