Non Smokers, Periodontal Disease, Periodontitis, Smokers
Conditions
Keywords
Injectable platelet-rich fibrin (I-PRF), Diode Laser, iodine solution, Periodontal Pockets, periodontal debridement, lasers, Regenerative periodontal therapy
Brief summary
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.
Detailed description
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. * By including smokers, this study addresses "the down to reality " challenge in dentistry. Smoking often impairs the blood supply to the gums; this trial investigates: if a biological approach like I-PRF (which introduces fresh growth factors) or a high-volume Antiseptic irrigation with Povidone-iodine, or a 980nm diode laser activation can overcome these healing barriers . The Key Research Goals: is to determine if the Biological group (I-PRF), which introduces high concentrations of growth factors and leukocytes, provides superior Probing Pocket Depth (PPD) reduction compared to an antiseptic group (Povidone-Iodine) and photobiomodulation group (diode laser activation). * The Smoking Factor: 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.
Interventions
BIOLOGICALInjectable Platelet-Rich Fibrin (I-PRF)
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
DEVICEDiode Laser Activation
Following scaling and root planing, periodontal pockets in the assigned quadrant will receive adjunctive diode laser activation according to the study protocol
DRUGPovidone-Iodine Irrigation (1%)
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.
PROCEDURESaline Irrigation (0.9%)
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.
PROCEDUREScaling and Root Planing
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.
Sponsors
Military Hospital of Tunis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: Patients with Stage II-IV Periodontitis; at least one bleeding pocket \> 4 mm minimum in every quadrant. Exclusion: patients who: * Pregnant /Lactating * History of radiotherapy or chemotherapy in the head/neck region. * Known hypersensitivity to Iodine or Methylene blue solution * Systematic antibiotic use within the last 30 days * Long-term use of immunosuppressants or corticosteroids (daily use) * type 1 / 2 diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on Probing (BOP) | Baseline, 3 months, and 6 months | 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 |
| Probing Pocket Depth (PPD) | Baseline, 3 months, and 6 months | 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. |
| Clinical Attachment Level (CAL) | Baseline, 3 months, and 6 months | 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. |
Countries
Tunisia
Contacts
CONTACTHela Jegham, DDS - Professor
CONTACThedi chouchene, DDS
STUDY_DIRECTORHela Jegham, DDS -Professor
Military Hospital of Instruction of Tunis
PRINCIPAL_INVESTIGATORhedi chouchene, DDS
Military Hospital of Instruction of Tunis
STUDY_DIRECTORRym masmoudi, DDS - Associate Professor
Military Hospital of Instruction of Tunis
PRINCIPAL_INVESTIGATORyassmine rjeb, DDS
Military Hospital of Instruction of Tunis
Outcome results
None listed