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This study aims to evaluate the clinical and microbiological effects of using injectable Platelet-Rich Fibrin (i-PRF) as an adjunct to non-surgical periodontal therapy (scaling and root planing) in patients with periodontitis. The study uses a split-mouth design where one side of the mouth receives the treatment with i-PRF and the other side receives standard treatment alone. Clinical parameters and bacterial counts will be compared at baseline, 1 month, and 3 months after intervention .
Patients with periodontitis will be recruited for this split-mouth randomized controlled trial. All participants will receive full-mouth supra and sub-gingival scaling and root planing (SRP). In the intervention side, i-PRF will be injected into the periodontal pockets, while the control side will receive SRP only.
Clinical measurements including Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), and Bleeding on Probing (BOP) will be recorded. Additionally, microbiological samples will be collected to assess the changes in the subgingival Porphyromonas gingivalis and Fusobacterium nucleatum . Follow-up visits are scheduled at 1 and 3 months post-intervention to assess the adjunctive benefit of i-PRF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: i-PRF + SRP | Experimental | This quadrant of the mouth will receive full-mouth scaling and root planing (SRP) followed by the subgingival injection of injectable Platelet-Rich Fibrin (i-PRF) into the periodontal pockets |
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| Active Comparator: SRP Alone | Active Comparator | This contralateral quadrant of the mouth will receive full-mouth scaling and root planing (SRP) only, serving as the control side to compare with the i-PRF intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectable Platelet-Rich Fibrin (i-PRF). | Biological | Ten ml of whole blood is collected from the participant into plain tubes and immediately centrifuged. The centrifugation protocol follows the low-speed concept (e.g., 700 rpm for 3 minutes). The upper orange-colored liquid (i-PRF) is then collected and injected subgingivally into the periodontal pockets using a 25-gauge needle immediately after scaling and root planing |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | Probing pocket depth will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a standardized periodontal probe (e.g., William's probe) at six sites per tooth. | Baseline, 1 month, and 3 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Attachment Level (CAL) | Measurement of the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket in millimeters. | Baseline, 1 month, and 3 months post-intervention |
| Bleeding on Probing (BOP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mustansiriyah University, College of Dentistry. | Baghdad | Iraq |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010514 | Periodontal Pocket |
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001862 | Bone Resorption |
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| ID | Term |
|---|---|
| C043309 | proliferation regulatory factors, human urine |
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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This is a split-mouth randomized controlled trial. Each participant receives both treatments in different quadrants of the mouth. One quadrant is randomly assigned to the intervention (Scaling and Root Planing + i-PRF) and the contralateral quadrant serves as the control (Scaling and Root Planing alone)
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The study follows a double-blind protocol regarding outcome assessment and data analysis. The clinical and microbiological examiner (Outcomes Assessor) is masked to the treatment allocation. Furthermore, the statistician (Statistical Investigator) will receive the data in a coded format (e.g., Side A and Side B) without knowing which side received the i-PRF intervention until the final analysis is completed
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| Scaling and Root Planing (SRP). | Procedure | Full-mouth non-surgical periodontal therapy including supra and sub-gingival scaling and root planing performed using ultrasonic devices and Gracey curettes to remove dental biofilm and calculus |
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Assessment of the presence or absence of bleeding within 30 seconds after probing, recorded as a percentage of total sites.
| Baseline, 1 month, and 3 months post intervention |
| Plaque Index (PI) | Assessment of the amount of dental plaque on the tooth surfaces to evaluate the patient's oral hygiene during the study. | Baseline, 1 month, and 3 months post intervention . |
| Microbiological Analysis (Bacterial Load) | Quantification of subgingival periodontal pathogens (P. gingivalis and F. nucleatum )using Quantitative Real-time PCR (qPCR) from subgingival plaque samples. | Baseline, 1 month, and 3 months post intervention |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |