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This study is a randomized, controlled, split-mouth clinical trial designed to evaluate and compare the effectiveness of four different subgingival adjuncts used along side standard Scaling and Root Planning (SRP). This protocol is designed to be a standardized therapeutic model. The subgingival adjuncts are standardized, ensuring that the results are not operator dependent and can be replicated across any dental unit. The primary goal of this study is to evaluate the clinical efficacy of three distinct adjunctive strategies: Biological (I-PRF), Antiseptic : Povidone- iodine , Diode-Laser activation, compared to a Saline Control in the initial treatment of stage 2, 3 and stage 4 of the 2018 AAP/EFP periodontal classification.
The investigators hypothesize that while all adjuncts will improve results over SRP and saline irrigation , the biological group (I-PRF) will show the most significant gains in the Smoker Subgroup due to its ability to stimulate local angiogenesis and tissue repair in a traditionally poor healing environment.
Investigator will explore if the regenerative properties of I-PRF can overcome the compromised healing response typically found in the Smoking Subgroup.
• Healing Quality: Investigator will identify which group shows the fastest reduction in inflammation, measured by Bleeding on Probing (BOP) and Clinical Attachment Level (CAL) gain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-PRF | Experimental | Quadrants randomly assigned to receive I-PRF irrigation after SRP |
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| Povidone-Iodine | Experimental | Quadrants randomly assigned to receive 1% povidone-iodine irrigation after SRP |
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| Diode Laser | Experimental | Quadrants randomly assigned to receive diode laser activation after SRP |
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| Saline Control | Sham Comparator | Quadrants randomly assigned to receive 0.9% saline irrigation after SRP |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectable Platelet-Rich Fibrin (I-PRF) | Biological | Following scaling and root planing, periodontal pockets in the assigned quadrant will receive 5 mL of injectable platelet-rich fibrin (I-PRF) prepared at 60 G for 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on Probing (BOP) | Bleeding on Probing (BOP) will be assessed within 15 seconds after gentle probing at six sites per tooth using a calibrated periodontal probe ( The instrument used (UNC-15 periodontal probe). The presence or absence of bleeding will be recorded and expressed as the percentage of bleeding sites per treatment quadrant. Measurements will be obtained by a blinded examiner at baseline, 3 months, and 6 months | Baseline, 3 months, and 6 months |
| Probing Pocket Depth (PPD) | Probing Pocket Depth (PPD) will be measured in millimeters using a calibrated UNC-15 periodontal probe at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual/palatal, midlingual/palatal, and distolingual/palatal). Measurements will be performed by a calibrated examiner blinded to treatment allocation at baseline, 3 months, and 6 months. | Baseline, 3 months, and 6 months |
| Clinical Attachment Level (CAL) | Clinical Attachment Level (CAL) will be measured in millimeters using a calibrated UNC-15 periodontal probe at six sites per tooth by measuring the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket. Assessments will be performed by a blinded calibrated examiner at baseline, 3 months, and 6 months. | Baseline, 3 months, and 6 months |
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Inclusion: Patients with Stage II-IV Periodontitis; at least one bleeding pocket > 4 mm minimum in every quadrant.
Exclusion: patients who:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hela Jegham, DDS - Professor | Contact | +21654241521 | hela.jegham@yahoo.fr | |
| hedi chouchene, DDS | Contact | +21652042177 | chouchanehadi76@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hela Jegham, DDS -Professor | Military Hospital of Instruction of Tunis | Study Director |
| hedi chouchene, DDS | Military Hospital of Instruction of Tunis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military Hospital of Instruction of Tunis | Recruiting | Tunis | Mont Fleury | 1008 | Tunisia |
identified individual participant data collected during the study will be shared, including demographic characteristics (age and sex), smoking status, baseline and follow-up periodontal measurements, including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), treatment allocation by quadrant, and outcome data used in the primary and secondary analyses.
Beginning 6 months after publication of the primary study results and ending 5 years after publication.
qualified researchers who provide a methodologically sound research proposal. Requests should be submitted to the principal investigator and will be reviewed in accordance with institutional policies, ethical requirements, and participant confidentiality protections.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2026 |
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| Diode Laser Activation | Device | Following scaling and root planing, periodontal pockets in the assigned quadrant will receive adjunctive diode laser activation according to the study protocol |
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| Povidone-Iodine Irrigation (1%) | Drug | Following scaling and root planing, periodontal pockets in the assigned quadrant will be irrigated with 5 mL of 1% povidone iodine solution delivered using a blunt-tip cannula. |
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| Saline Irrigation (0.9%) | Procedure | Following scaling and root planing, periodontal pockets in the assigned quadrant will be irrigated with 5 mL of sterile 0.9% saline solution delivered using a blunt-tip cannula. This intervention serves as the control treatment for comparison with the adjunctive therapies. |
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| Scaling and Root Planing | Procedure | Conventional non surgical periodontal therapy consisting of supra and subgingival scaling and root planing performed using hand and ultrasonic instruments. All study quadrants will receive SRP before adjunctive treatment allocation. |
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| Rym masmoudi, DDS - Associate Professor |
| Military Hospital of Instruction of Tunis |
| Study Director |
| yassmine rjeb, DDS | Military Hospital of Instruction of Tunis | Principal Investigator |
| Jul 10, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 6, 2026 | Jul 10, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D010514 | Periodontal Pocket |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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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 |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |
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