Alveolar Bone Loss, Periodontal Pocket, Periodontitis
Conditions
Keywords
Injectable Platelet-Rich Fibrin, i-PRF, Scaling and Root Planing, Non-Surgical Periodontal Therapy, Split-mouth design, Microbiological outcomes, Periodontitis, Regeneration
Brief summary
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 .
Detailed description
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.
Interventions
BIOLOGICALInjectable Platelet-Rich Fibrin (i-PRF).
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
PROCEDUREScaling and Root Planing (SRP).
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
Sponsors
Al-Mustansiriyah University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subjects aged 30 years and above. * No history of systemic diseases (e.g., diabetes mellitus). * Not currently under active periodontal therapy or joining other trial in the last 3 months. * Diagnosis with Stage II or III Periodontitis. * presence of interdental CAL affecting ≥2 non adjacent teeth or if CAL at buccal/lingual aspects associated with PPD \>4mm at ≥2 teeth.
Exclusion criteria
* Smokers or alcohol users. * Patients consuming antibiotics or anticoagulants. * Regular users of non-steroidal anti-inflammatory drugs. * Receipt of periodontal treatment within 3 months prior to the study. * Any bleeding or clotting disorders. * Teeth with Grade II or Grade III furcation involvement. * Pregnant or breastfeeding mothers. * Patients unwilling to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | Baseline, 1 month, and 3 months post-intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level (CAL) | Baseline, 1 month, and 3 months post-intervention | Measurement of the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket in millimeters. |
| Bleeding on Probing (BOP) | Baseline, 1 month, and 3 months post intervention | Assessment of the presence or absence of bleeding within 30 seconds after probing, recorded as a percentage of total sites. |
| Plaque Index (PI) | Baseline, 1 month, and 3 months post intervention . | Assessment of the amount of dental plaque on the tooth surfaces to evaluate the patient's oral hygiene during the study. |
| Microbiological Analysis (Bacterial Load) | Baseline, 1 month, and 3 months post intervention | Quantification of subgingival periodontal pathogens (P. gingivalis and F. nucleatum )using Quantitative Real-time PCR (qPCR) from subgingival plaque samples. |
Countries
Iraq
Outcome results
None listed