Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2023-08-19
2025-12-16
Brief Summary
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Detailed Description
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1. Test group: After gingival flap reflection and debridement of bone and root surfaces L-PRF will be applied to the alveolar bone, tooth roots, and gingival flap prior to suturing.
2. Control group (Standard of care): Gingival flap reflection and debridement of bone and root surfaces, followed by suturing of the gingival flaps.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group OFD + L-PRF
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.
Leukocyte Platelet-rich fibrin
Leukocyte-PRF (L-PRF) contains neutrophils and macrophages that facilitate bacteria and necrotic tissue elimination via phagocytosis
Group OFD
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.
Standard of care OFD
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.
Interventions
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Leukocyte Platelet-rich fibrin
Leukocyte-PRF (L-PRF) contains neutrophils and macrophages that facilitate bacteria and necrotic tissue elimination via phagocytosis
Standard of care OFD
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients needing open flap debridement procedures for periodontal disease in one or more teeth in the same arch bilaterally (split mouth)
* Patients must be nonsmokers, former smokers, or current smokers who smoke \<10 cigarettes per day, by self-report
* Female patients to include non- pregnant women of child-bearing potential.
Exclusion Criteria
* Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
* Pregnant women or women intending to become pregnant during the study period
* Smokers who smoke \> 10 cigarettes per day
18 Years
89 Years
ALL
Yes
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Charles Powell, DDS, MS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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20230505HU
Identifier Type: -
Identifier Source: org_study_id
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