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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04507009
Enrollment
60
Registered
2020-08-10
Start date
2020-08-01
Completion date
2022-10-01
Last updated
2022-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Osteitis

Keywords

Alveolitis, Dry socket, Ozone, CGF

Brief 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.

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.

Interventions

DEVICEOzone

topical gaseous ozone application

OTHERCGF

concentrated growth factor (CGF) application

OTHERTraditional treatment

Alvogyl application

Sponsors

Ordu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in post-operative pain assessed: visual analog (VAS) scale6th and 24th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th dayFor 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.

Secondary

MeasureTime frameDescription
Granulation tissue healthpostoperative 1st, 3rd, 7th daysGranulation 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).
Inflamation severitypostoperative 1st, 3rd, 7th daysThe severity of inflammation will be assessed using the gingival index; From values 0 to 3; 0.Normal gingiva 1. Slight inflammation-slight discoloration, mild edema. no probing on bleeding, 2. Moderate inflammation - redness, edema. bleeding on probing, 3. Severe inflammation-marked redness and edema, ulceration and tendency to spontaneous bleeding
Change in the quality of postoperative life after the procedures performedpostoperative 7th dayThe 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.

Other

MeasureTime frameDescription
Oral hygiene degreeEvaluation of the oral hygiene before operationOral 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026