Clinical Investigation of the Efficacy of CGF and Ozone in the Treatment of Alveolar Osteitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Investigation of the Efficacy of CGF (Concentrated Growth Factor) and Ozone in the Treatment of Alveolar Osteitis

Conditions
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Alveolar Osteitis

Intervention / Treatment
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* Device: Ozone
* Other: CGF
* Other: Traditional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Traditional treatment group which alvogyl applied to the socket after irrigation | Other: Traditional treatment<br>* Alvogyl application<br>|
| Experimental: Ozone<br>Ozone group which Ozone (O3) applied after irrigation of the socket | Device: Ozone<br>* topical gaseous ozone application<br>|
| Experimental: CGF +Ozone<br>CGF + Ozone group which concentrated growth factor (CGF) after Ozone (O3) applied followed by irrigation of the socket. | Device: Ozone<br>* topical gaseous ozone application<br>Other: CGF<br>* concentrated growth factor (CGF) application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6th and 24th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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. | postoperative 7th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alveolitis, Dry socket, Ozone, CGF