Bony Defects, Periodontal Disease
Conditions
Keywords
Intrabony defects, periodontitis, MINST, i-PRF, CHX
Brief summary
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.
Detailed description
The microbial profile shift that occurs during the transition from periodontal health to gingivitis or periodontitis makes it clear that the initiation and progression of periodontal diseases depend totally upon the presence of a dental biofilm. This microbial shift provides the rationale for the main objective of periodontal therapy, which aims to convert the biofilm from being associated with disease to being associated with health. Accordingly, the most effective therapies depend on relatively nonspecific approaches that physically disrupt the biofilm and decrease the oral bacterial load (Craig, 2016). Using modified PRF with anti-bacterial properties can be highly important as a topical surgical tool that promotes tissue healing and prevents local infection (Polak, Clemer-Shamai and Shapira, 2019; El-Sayed et al., 2026). Moreover, such application may reduce the need for systemic antibiotic regimens (Polak, Clemer-Shamai and Shapira, 2019). More recently, a novel protocol termed minimally invasive nonsurgical therapy (MINST) has been proposed for the treatment of isolated deep pockets associated with intrabony defects. Treatment of deep periodontal pockets by means of MINST consists of careful scaling and root debridement using special ultrasonic devices with delicate tips and operating microscope under local anesthesia (Nibali et al., 2019). Since the incorporation of antiseptics into I-PRF hasn't been tested clinically yet, this study intends to evaluate the clinical and radiographic effects of using Chorhexidine augmented injrctable-platelet-rich fibrin together minimally invasive non-surgical periodontal therapy in the treatment stage III periodontitis patients.
Interventions
PROCEDUREMinimally Invasive Nonsurgical Therapy
careful 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.
BIOLOGICALInjectable Platelet-Rich Fibrin
careful 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.
DRUGChlorhexidine 2%
careful 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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient-related criteria: * Patient consulting in the outpatient clinic. * Age ≥ 18 years old. * Able to tolerate the study procedures. * Patient ready to perform oral hygiene instructions. * Compliance with the maintenance program. * Provide informed consent. * Accepts the 6 months follow-up period. Teeth related criteria: * Presence of at least one radiographic intrabony defect depth ≥3 mm. * Patients with at least 10 teeth per arch. * Presence at least of two teeth with PD ≥ 6 mm per quadrant. * Isolated inter-proximal defect on a single-rooted tooth or mandibular molar, not extending to the furcation area. * Untreated patients diagnosed with stage III with slow/moderate rate of progression grade (A/B) Periodontitis.
Exclusion criteria
* Patient-related criteria: * Medically compromised patients. * Pregnant or nursing women. * Uncooperative patients. * Smokers (\> 10 cigarettes/day). Teeth related criteria: * Furcation involvement. * Mobility ≥ degree 1 * Acute periodontal or endodontic abscesses * Third molars * Non-surgical periodontal treatment in the past 6 months, or surgical periodontal treatment in the past 12 months. * Antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy. * Previous periodontal surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth reduction (PD) | From enrollment to the end of treatment at 6 months | Will be measured from the gingival margin to the bottom of the gingival sulcus. Unit of Measurement Millimeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level (CAL) | From enrollment to the end of treatment at 6 months | Will be measured from the CEJ to the bottom of the gingival sulcus. Unit of Measurement Millimeter |
| Gingival recessions (GR) | From enrollment to the end of treatment at 6 months | 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) | From enrollment to the end of treatment at 6 months | * 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 | at end of treatment at 6 months | 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 |
| Perceived post-operative pain/discomfort | at the end of treatment at 6 months | * Visual Analog Scale (VAS): 0 (no pain) to 10 (worst pain). * Binary (Yes/No): Presence or absence of pain. unit of measurement: VAS Scale |
| Radiographic Linear defect depth (RLDD) | From enrollment to the end of treatment at 6 months | The radiographic linear defect depth (RLDD) will be calculated as the linear distance between the defect base (DB) and the point where a line projected from the alveolar crest (AC) intersects the long axis of the tooth at baseline and again at the 6-month follow-up. In addition, the baseline defect angle will be determined as the angle formed between the line joining the CEJ and DB and the lateral wall of the defect. Unit of Measurement : Millimeter |
| Plaque index (PI) | From enrollment to the end of treatment at 6 months | After drying the teeth in each quadrant with a blast of air, and presence of visible dental plaque and supragingival calculus will be recorded. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) will be given a score from 0-3. The scores from the four areas of the tooth will be added and divided by four to give the plaque index for the tooth with the following scores and criteria. Unit of measurement: Percentage of tooth sites revealing the presence of plaque |
| Bleeding on probing | From enrollment to the end of treatment at 6 months | By gentle probing of the orifice of the gingival crevice. The periodontal probe will be inserted 1 to2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded . Unit of measurement: Percentage of sites with bleeding on probing |
Contacts
CONTACTSalma ossama Zaaya, Master Degree
CONTACTKarim fawzy El-sayed, professor
STUDY_CHAIRKarim Fawzy El-sayed, Professor
Cairo University
STUDY_DIRECTORWeam Elbattawy, Professor
Cairo University
Outcome results
None listed