Clinical Investigation of the Efficacy of CGF and Ozone in the Treatment of Alveolar Osteitis
Primary Purpose
Alveolar Osteitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ozone
CGF
Traditional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Osteitis focused on measuring Alveolitis, Dry socket, Ozone, CGF
Eligibility Criteria
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
Sites / Locations
- Ordu University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control
Ozone
CGF +Ozone
Arm Description
Traditional treatment group which alvogyl applied to the socket after irrigation
Ozone group which Ozone (O3) applied after irrigation of the socket
CGF + Ozone group which concentrated growth factor (CGF) after Ozone (O3) applied followed by irrigation of the socket.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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
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.
Full Information
NCT ID
NCT04507009
First Posted
August 4, 2020
Last Updated
November 5, 2022
Sponsor
T.C. ORDU ÜNİVERSİTESİ
1. Study Identification
Unique Protocol Identification Number
NCT04507009
Brief Title
Clinical Investigation of the Efficacy of CGF and Ozone in the Treatment of Alveolar Osteitis
Official Title
Clinical Investigation of the Efficacy of CGF (Concentrated Growth Factor) and Ozone in the Treatment of Alveolar Osteitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
T.C. ORDU ÜNİVERSİTESİ
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Osteitis
Keywords
Alveolitis, Dry socket, Ozone, CGF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Traditional treatment group which alvogyl applied to the socket after irrigation
Arm Title
Ozone
Arm Type
Experimental
Arm Description
Ozone group which Ozone (O3) applied after irrigation of the socket
Arm Title
CGF +Ozone
Arm Type
Experimental
Arm Description
CGF + Ozone group which concentrated growth factor (CGF) after Ozone (O3) applied followed by irrigation of the socket.
Intervention Type
Device
Intervention Name(s)
Ozone
Intervention Description
topical gaseous ozone application
Intervention Type
Other
Intervention Name(s)
CGF
Intervention Description
concentrated growth factor (CGF) application
Intervention Type
Other
Intervention Name(s)
Traditional treatment
Intervention Description
Alvogyl application
Primary Outcome Measure Information:
Title
Change in post-operative pain assessed: visual analog (VAS) scale
Description
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.
Time Frame
6th and 24th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day
Secondary Outcome Measure Information:
Title
Granulation tissue health
Description
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).
Time Frame
postoperative 1st, 3rd, 7th days
Title
Inflamation severity
Description
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
Time Frame
postoperative 1st, 3rd, 7th days
Title
Change in the quality of postoperative life after the procedures performed
Description
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.
Time Frame
postoperative 7th day
Other Pre-specified Outcome Measures:
Title
Oral hygiene degree
Description
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.
Time Frame
Evaluation of the oral hygiene before operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damla Torul, DDS PhD
Organizational Affiliation
T.C. ORDU ÜNİVERSİTESİ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ordu University
City
Ordu
ZIP/Postal Code
52200
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD can share with other researchers on demand
Learn more about this trial
Clinical Investigation of the Efficacy of CGF and Ozone in the Treatment of Alveolar Osteitis
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