Back to resultsCGF Influence on Post-operative Complications.
Primary Purpose
CGF, Bone Loss, Post-operative Wound Healing
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
CGF application
Sponsored by
About this trial
This is an interventional treatment trial for CGF
Eligibility Criteria
Inclusion Criteria:
- no known medical history of abnormal platelet counts,
- patients with symmetric teeth qualified for extraction,
Exclusion Criteria:
- systemic diseases,
- pregnancy,
- lactation,
- drugs known to affect the number or function of platelets,
- abnormal platelet counts
Sites / Locations
- Department of Oral SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Intensity of pain vs. CGF application
In order to evaluate the relationship between intensity of pain after surfery and filling the alveolus with platelet-rich plasma, , NRS (Numeric Rating Scale) pain scale is used.
NRS scale, ranges from 0 to 10; where 0 refers to no pain and 10 refers to most severe pain.
Secondary Outcome Measures
Occurrence of swelling
The presence of swelling was evaluated using zero one system.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03992573
Brief Title
CGF Influence on Post-operative Complications.
Official Title
The Influence of Concentrated Growth Factors (CGF) Application on Post-operative Complications.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (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 CGF application into post-operative soft tissue and bone defects on post-operative complications and wound healing.
Detailed Description
The research was conducted in twenty patients with symmetric single tooth qualified to extraction. On one side of dental arch, post-operative region was field with CGF material, while on the other side it was left to normal healing. In both cases pain, swelling, alveolar osteitis, antibiotics and analgesics intake in post-operative period were evaluated in the first, fourth and seventh day after surgery. Wound healing was assessed seven and thirty days after extraction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CGF, Bone Loss, Post-operative Wound Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
CGF application
Intervention Description
CGF application into post-operative soft tissue and bone defects
Primary Outcome Measure Information:
Title
Intensity of pain vs. CGF application
Description
In order to evaluate the relationship between intensity of pain after surfery and filling the alveolus with platelet-rich plasma, , NRS (Numeric Rating Scale) pain scale is used.
NRS scale, ranges from 0 to 10; where 0 refers to no pain and 10 refers to most severe pain.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Occurrence of swelling
Description
The presence of swelling was evaluated using zero one system.
Time Frame
24 hours
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:
no known medical history of abnormal platelet counts,
patients with symmetric teeth qualified for extraction,
Exclusion Criteria:
systemic diseases,
pregnancy,
lactation,
drugs known to affect the number or function of platelets,
abnormal platelet counts
Facility Information:
Facility Name
Department of Oral Surgery
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Janas-Naze, Prof.
Phone
+48601229495
Email
anna.janas@umed.lodz.pl
12. IPD Sharing Statement
Plan to Share IPD
No
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CGF Influence on Post-operative Complications.
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