A Phase 4 interventional study of Injectable Platelet-Rich Fibrin (I-PRF) and Diode Laser Activation in Periodontitis, Smokers and Non Smokers, sponsored by Military Hospital of Tunis. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Military Hospital of Tunis · Phase 4, Interventional, and Treatment
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 50 is above the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Military Hospital of Tunis is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion: Patients with Stage II-IV Periodontitis; at least one bleeding pocket > 4 mm minimum in every quadrant.
Exclusion: patients who:
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Quadrants randomly assigned to receive I-PRF irrigation after SRP
Biological: Injectable Platelet-Rich Fibrin (I-PRF) · Procedure: Scaling and Root Planing
Quadrants randomly assigned to receive 1% povidone-iodine irrigation after SRP
Drug: Povidone-Iodine Irrigation (1%) · Procedure: Scaling and Root Planing
Quadrants randomly assigned to receive diode laser activation after SRP
Device: Diode Laser Activation · Procedure: Scaling and Root Planing
Quadrants randomly assigned to receive 0.9% saline irrigation after SRP
Procedure: Saline Irrigation (0.9%) · Procedure: Scaling and Root Planing
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
Following scaling and root planing, periodontal pockets in the assigned quadrant will receive adjunctive diode laser activation according to the study protocol
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.
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.
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.
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
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months, and 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Beginning 6 months after publication of the primary study results and ending 5 years after publication.
Access criteria: 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.
Started May 2026 (actual). Primary completion is estimated for May 2027, 11 months after the start.
Of 29 non-industry phase 4 interventional studies under Periodontitis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 22. This study's planned 11 months is below that.
Counting every sponsor, half of 30 studies reached it within 11 months; a quarter within 7 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
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Military Hospital of Tunis