Periodontal Diseases
Conditions
Keywords
Open flap debridement, Periodontal surgery, Periodontal wound healing
Brief summary
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.
Detailed description
Randomization to one of two standard of care procedures: 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.
Interventions
PROCEDURELeukocyte Platelet-rich fibrin
Leukocyte-PRF (L-PRF) contains neutrophils and macrophages that facilitate bacteria and necrotic tissue elimination via phagocytosis
OTHERStandard 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.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to the intervention which they are randomized to.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients between age 18 and 89 * 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 disclose that they will not be able to cooperate with the follow-up schedule. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth | 3 months and 6 months | Depth of gingival pocket |
| Postoperative Pain (PROM) | 12 to 168 hours post surgery | 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. |
Countries
United States
Outcome results
None listed