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

Alveolar Osteitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04507009
• Other study ID #: A-2005
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2022
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Osteitis
• Dry Socket
• Osteitis

Intervention

Device:
• Ozone
topical gaseous ozone application

Other:
• CGF
concentrated growth factor (CGF) application
• Traditional treatment
Alvogyl application

Locations

Country	Name	City	State
Turkey	Ordu University	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oral hygiene degree	Oral hygiene of the patient will be evaluated in 3 groups as poor, moderate and good.; Good; Patients with a low incidence of active caries,; Patients with no bleeding and non-inflamed gums, as well as no plaque, calculus, and gingival pocket formation.; Bad; Patients with periodontitis, inflamed gums, bleeding on probing, pocket formation,calculus; Patients with active caries.; Moderate; Patients other than these two groups will be evaluated as moderate.	Evaluation of the oral hygiene before operation
Primary	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	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
Secondary	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
Secondary	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