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

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Osteitis
• Intervention / Treatment: Other: Traditional treatment; Device: Ozone; Other: CGF

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ordu, Turkey, 52200
    • Ordu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral hygiene degree	Oral hygiene of the patient will be evaluated in 3 groups as poor, moderate and good.; GoodPatients 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.; BadPatients with periodontitis, inflamed gums, bleeding on probing, pocket formation,calculusPatients with active caries.; ModeratePatients other than these two groups will be evaluated as moderate.	Evaluation of the oral hygiene before operation

Collaborators and Investigators

• Sponsor: T.C. ORDU ÜNİVERSİTESİ
• Investigators: Principal Investigator: damla torul, DDS PhD, T.C. ORDU ÜNİVERSİTESİ

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 5, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Dry socket; Alveolitis; Ozone; CGF
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Bone Diseases; Osteitis; Dry Socket
• Other Study ID Numbers: A-2005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD can share with other researchers on demand

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No