About this trial
This study aims to assess the effect of chlorhexidine augmented I-PRF together with MINST and I-PRF alone with MINST versus MINST alone in the treatment of stage III periodontitis patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient consulting in the outpatient clinic.
Age ≥ 18 years old.
Able to tolerate the study procedures.
Patient ready to perform oral hygiene instructions.
Disqualifiers
Medically compromised patients.
Pregnant or nursing women.
Uncooperative patients.
Smokers (> 10 cigarettes/day).
Trial design
Parallel
Treatments tested in this trial
Minimally Invasive Nonsurgical Therapy
Procedure/Surgerycareful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed.
Injectable Platelet-Rich Fibrin
Biological/Vaccinecareful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient.
Chlorhexidine 2%
Drugcareful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. Before the collection and centrifugation of the blood from volunteers, 200 microliter of the drug solution is dispensed at the bottom of the eppendorf vial microtube and kept ready. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient. Once I-PRF is obtained after centrifugation, 2 ml of it is added to the eppendorf vortexex
Treatment groups
Trial outcomes
Primary outcomes
Probing depth reduction (PD)
Will be measured from the gingival margin to the bottom of the gingival sulcus. Unit of Measurement Millimeter
Secondary outcomes
Clinical Attachment Level (CAL)
Will be measured from the CEJ to the bottom of the gingival sulcus. Unit of Measurement Millimeter
Gingival recessions (GR)
Will be measured from the CEJ to the gingival margin. Unit of Measurement Millimeter
Biochemical marker levels in GCF samples (TNF-α, IL-1β and IL-10 levels)
* GCF sampling will be collected from the deepest pocket in the interproximal sites of the selected teeth of all patients at baseline; 1 day after recording the clinical periodontal measurements, 3 and 6 months. * The site selected for sample collection will be isolated with cotton rolls and protected against saliva contamination. * The supragingival plaque in the site will be removed using cotton pellets. * Periopaper will be pushed into the gingival sulcus until mild resistance felt. * After 30 seconds, it will be removed, and its volume will be measured by the Periotron device. Before each sample collection, the standardization will be maintained by the calibration of the Periotron device. * The measured values will be converted to microliters. * Three GCF samples from each patient will be placed into single Eppendorf tubes and stored at -80 degrees until the biochemical analyses. * Enzyme-linked immunosorbent assay (ELISA) method will be used to determine the GCF levels
Patient reported outcomes
Oral health-related quality of life (OHRQoL) will be evaluated using the validated Oral Health Impact Profile (OHIP-14) questionnaire, a widely used instrument designed to assess the functional, psychological, and social effects of oral health conditions on daily life. The OHIP-14 includes 14 items distributed across seven conceptual domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Participants will complete the OHIP-14 questionnaire at baseline and again at the 6-month post-treatment follow-up to determine changes in their perceived oral health status and overall quality of life. The inclusion of this patient-reported outcome measure allows for a broader assessment of treatment outcomes, capturing patient perceptions and experiences in addition to clinical findings. Unit of Measurement: OHIP-1TO, OHIP-14
Locations
Sponsors and contacts
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