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The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception.
Randomization to one of two standard of care procedures:
The study is a split-mouth design, randomized, prospective clinical trial. The protocol will randomize gingival quadrants in subjects to one of two standard of care procedures OFD or OFD + L-PRF. Patients needing periodontal surgery to correct periodontal disease will be enrolled. There will be two subject groups in this study. Each subject will be randomized to one of the treatments for the first quadrant and the contralateral quadrant will receive the other treatment. No risk is expected from being assigned to either group as both procedures are standard of care, with possible benefit of enhanced wound healing and bone regeneration in the test group.
Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group OFD + L-PRF | Active Comparator | Open flap debridement (OFD) with L-PRF is used during periodontal surgical procedure that is used to improve periodontal health by providing access to the tooth roots and alveolar bone. |
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| Group OFD | Other | Open flap debridement (OFD) is one periodontal surgical procedure that is used to improve periodontal health by providing access to the tooth roots and alveolar bone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leukocyte Platelet-rich fibrin | Procedure | Leukocyte-PRF (L-PRF) contains neutrophils and macrophages that facilitate bacteria and necrotic tissue elimination via phagocytosis |
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| Measure | Description | Time Frame |
|---|---|---|
| Probing depth | Depth of gingival pocket | 3 months and 6 months |
| Postoperative Pain (PROM) | Change in Patient reported outcome measures measured by a 10 point scale with 0 being no pain and 10 is the worst pain ever experienced. | 12 to 168 hours post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Powell, DDS, MS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
All deidentified participant data will be shared with colleagues
After study completion in a peer review journal
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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The proposed study is a split-mouth design, randomized, prospective clinical trial in which we will use either OFD alone or OFD + L-PRF for periodontal surgery. Both procedures are standard of care
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Participants will be blinded to the intervention which they are randomized to.
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| Standard of care OFD | Other | Open flap debridement (OFD) is one periodontal surgical procedure that is used to improve periodontal health by providing access to the tooth roots and alveolar bone. |
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