- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07375004
Injectable PRF in Non-Surgical Periodontal Treatment (IPRF-PERIO)
Adjunctive Use of Injectable PRF in Non-surgical Periodontal Therapy: Clinical and Microbiological Outcomes ( Split - Mouth Randomized Controlled Trial )
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Baghdad, Iraq
- Mustansiriyah University, College of Dentistry.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: i-PRF + SRP
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
|
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
Other Names:
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
Other Names:
|
|
Active Comparator: Active Comparator: SRP Alone
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.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Probing Pocket Depth (PPD)
Time Frame: 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.
|
Baseline, 1 month, and 3 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Attachment Level (CAL)
Time Frame: 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.
|
Baseline, 1 month, and 3 months post-intervention
|
|
Bleeding on Probing (BOP)
Time Frame: Baseline, 1 month, and 3 months post intervention
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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)
Time Frame: Baseline, 1 month, and 3 months post intervention .
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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)
Time Frame: 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.
|
Baseline, 1 month, and 3 months post intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Bone Resorption
- Bone Diseases
- Musculoskeletal Diseases
- Periodontal Atrophy
- Periodontal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Alveolar Bone Loss
- Periodontitis
- Periodontal Pocket
- Digestive System and Oral Physiological Phenomena
- Dentistry
- Dental Physiological Phenomena
- Dental Scaling
- Dental Prophylaxis
- Periodontics
- Subgingival Curettage
- Preventive Dentistry
- proliferation regulatory factors, human urine
- Root Planing
- Tooth Exfoliation
Other Study ID Numbers
- UOM-DENT-ETHIC-2026-042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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