Back to resultsUse of PRF in Treatment of Dry Socket.
Primary Purpose
Alveolar Osteitis
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
PRF application
Nipas application
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Osteitis focused on measuring dry socket, PRF
Eligibility Criteria
Inclusion Criteria:
- no known medical history of abnormal platelet counts,
- patients with symmetric teeth qualified for extraction,
Exclusion Criteria:
- patients treated previously for existing dry socket,
- patients allergic to acetylsalicylic acid ,
- systemic diseases,
- pregnancy,
- lactation,
- drugs known to affect the number or function of platelets,
- abnormal platelet counts,
Sites / Locations
- Department of Oral Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRF application
Aspirin application
Arm Description
Patients with alveolar osteitis in which PRF application was performed.
Patients with alveolar osteitis in which Nipas was used.
Outcomes
Primary Outcome Measures
Intensity of pain vs. PRF and Nipas application
In order to evaluate the relationship between intensity of pain after application of PRF and Nipas, Numeric Rating Scale pain scale is used. NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
The higher score means worse outcome in case of present study.
Influence of treatment on bacteria levels in wounds
The second part of the study was dedicated to analyzing the number of bacteria in tooth extraction wounds.
Secondary Outcome Measures
Full Information
NCT ID
NCT04476121
First Posted
July 15, 2020
Last Updated
April 23, 2021
Sponsor
Medical University of Lodz
1. Study Identification
Unique Protocol Identification Number
NCT04476121
Brief Title
Use of PRF in Treatment of Dry Socket.
Official Title
Evaluation of Platelet Rich Fibrin Use in the Treatment of Dry Socket.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lodz
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 the study is to evaluate the influence of PRF application in case of alveolar osteitis.
Detailed Description
The main objective was to compare the effects of using two different methods in the treatment of dry socket (alveolar osteitis), which is a postoperative complication of dental extraction. The first was Nipas, applied, if dry socket was diagnosed following a tooth extraction. In case of subsequent extraction of homonymous tooth and reoccurrence of dry socket, patients were treated with application of PRF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Osteitis
Keywords
dry socket, PRF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The first medicine was applied, if dry socket was diagnosed following a tooth extraction. In case of subsequent extraction of homonymous tooth in the same patient and reoccurrence of dry socket, patients were treated with PRF application.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRF application
Arm Type
Experimental
Arm Description
Patients with alveolar osteitis in which PRF application was performed.
Arm Title
Aspirin application
Arm Type
Active Comparator
Arm Description
Patients with alveolar osteitis in which Nipas was used.
Intervention Type
Procedure
Intervention Name(s)
PRF application
Intervention Description
PRF application into post-operative wound.
Intervention Type
Drug
Intervention Name(s)
Nipas application
Other Intervention Name(s)
Aspirin paste
Intervention Description
Nipas application into post-operative wound.
Primary Outcome Measure Information:
Title
Intensity of pain vs. PRF and Nipas application
Description
In order to evaluate the relationship between intensity of pain after application of PRF and Nipas, Numeric Rating Scale pain scale is used. NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
The higher score means worse outcome in case of present study.
Time Frame
24 hours
Title
Influence of treatment on bacteria levels in wounds
Description
The second part of the study was dedicated to analyzing the number of bacteria in tooth extraction wounds.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
no known medical history of abnormal platelet counts,
patients with symmetric teeth qualified for extraction,
Exclusion Criteria:
patients treated previously for existing dry socket,
patients allergic to acetylsalicylic acid ,
systemic diseases,
pregnancy,
lactation,
drugs known to affect the number or function of platelets,
abnormal platelet counts,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Janas-Naze, Prof.
Organizational Affiliation
Medical University of Lodz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oral Surgery
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Use of PRF in Treatment of Dry Socket.
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