A Phase 1/2 interventional study of Minimally Invasive Nonsurgical Therapy and Injectable Platelet-Rich Fibrin in Bony Defects and Periodontal Disease, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Cairo University · Phase 1/2, Interventional, and Treatment
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.
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 63 is above the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Compared within Periodontitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Periodontal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient-related criteria:
Teeth related criteria:
Exclusion Criteria:
Patient-related criteria:
Teeth related criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Procedure: Minimally 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. 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.
Procedure: Minimally Invasive Nonsurgical Therapy · Biological: Injectable 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. 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
Procedure: Minimally Invasive Nonsurgical Therapy · Biological: Injectable Platelet-Rich Fibrin · Drug: Chlorhexidine 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.
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.
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
Probing depth reduction (PD)
Will be measured from the gingival margin to the bottom of the gingival sulcus. Unit of Measurement Millimeter
Time frame: From enrollment to the end of treatment at 6 months
Clinical Attachment Level (CAL)
Will be measured from the CEJ to the bottom of the gingival sulcus. Unit of Measurement Millimeter
Time frame: From enrollment to the end of treatment at 6 months
Gingival recessions (GR)
Will be measured from the CEJ to the gingival margin. Unit of Measurement Millimeter
Time frame: From enrollment to the end of treatment at 6 months
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
Time frame: From enrollment to the end of treatment at 6 months
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
Time frame: at end of treatment at 6 months
Perceived post-operative pain/discomfort
* Visual Analog Scale (VAS): 0 (no pain) to 10 (worst pain). * Binary (Yes/No): Presence or absence of pain. unit of measurement: VAS Scale
Time frame: at the end of treatment at 6 months
Radiographic Linear defect depth (RLDD)
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
Time frame: From enrollment to the end of treatment at 6 months
Plaque index (PI)
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
Time frame: From enrollment to the end of treatment at 6 months
Bleeding on probing
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
Time frame: From enrollment to the end of treatment at 6 months
No study locations are listed for this record.
Plan to share: Undecided
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Studies of the drug tested here: Chlorhexidine