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| ID | Type | Description | Link |
|---|---|---|---|
| BAP04-B-2024-5249 | Other Identifier | Ondokuz Mayıs University |
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The goal of this clinical trial is to learn if adding platelet-rich fibrin (PRF) or injectable platelet-rich fibrin (i-PRF), obtained from the participant's own blood, to standard non-surgical periodontal treatment helps improve gum health in individuals with periodontitis. It will also assess how these applications affect inflammation and bone-related markers in the gum fluid. The main questions it aims to answer are :
Participants will:
his study was designed as a randomized controlled clinical trial to evaluate the adjunctive effects of platelet-rich fibrin (PRF) and injectable platelet-rich fibrin (i-PRF) in individuals with periodontitis undergoing non-surgical periodontal therapy (NSPT).
A total of 56 participants were included in the study, comprising 42 systemically healthy patients diagnosed with periodontitis and 14 systemically and periodontally healthy individuals serving as controls. Periodontitis patients were randomly allocated into three treatment groups using a sealed-envelope method: NSPT alone (scaling and root planing, SRP), NSPT with adjunctive PRF application, and NSPT with adjunctive i-PRF application.
PRF and i-PRF were prepared from autologous venous blood obtained from the participants and were applied locally into periodontal pockets immediately following SRP.
Clinical periodontal parameters were recorded at baseline and at the 2nd, 4th, and 6th weeks following treatment. Gingival crevicular fluid (GCF) samples were collected at baseline and at the 2nd and 6th weeks. The levels of inflammatory cytokines (IL-1β, TNF-α, IL-6) and bone metabolism-related biomarkers (OPG and RANKL) in GCF were quantified using enzyme-linked immunosorbent assay (ELISA).
The findings of this study provided insight into the potential clinical and biochemical benefits of PRF and i-PRF as adjunctive approaches in NSPT and allowed comparison with periodontally healthy conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-surgical periodontal therapy (NSPT) | Active Comparator | Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). No adjunctive biomaterial was applied. |
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| NSPT + PRF | Experimental | Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). Following NSPT, platelet-rich fibrin (PRF) was applied into periodontal pockets. |
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| NSPT + i-PRF | Experimental | Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). Following NSPT, injectable platelet-rich fibrin (i-PRF) was applied into periodontal pockets. |
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| Healthy control | No Intervention | Periodontally and systemically healthy participants were included as controls. No periodontal treatment was performed. Gingival crevicular fluid (GCF) samples were collected, and oral hygiene instructions were provided |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-surgical periodontal therapy (NSPT) | Procedure | Non-surgical periodontal therapy (NSPT) consisted of full-mouth scaling and root planing (SRP), including the removal of supra- and subgingival deposits using ultrasonic devices and hand instruments. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in probing depth (PD) | Change in probing depth (PD) measured in millimeters at six sites per tooth using a periodontal probe, comparing baseline values with follow-up measurements. | Baseline, 2 weeks, 4 weeks, and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in clinical attachment level (CAL) | Change in clinical attachment level (CAL) measured in millimeters at six sites per tooth using a periodontal probe, comparing baseline and follow-up measurements. | Baseline, 2 weeks, 4 weeks, and 6 weeks |
| Change in plaque index (PI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ondokuz Mayıs University | Samsun | Atakum | 55200 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C043309 | proliferation regulatory factors, human urine |
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| Platelet-rich fibrin (PRF) | Biological | Platelet-rich fibrin (PRF) was prepared from autologous venous blood by centrifugation at 2700 rpm for 12 minutes, processed into a membrane, adapted to the size of the periodontal pocket, and placed into the periodontal pocket using hand instruments. |
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| Injectable platelet-rich fibrin (i-PRF) | Biological | Injectable platelet-rich fibrin (i-PRF) was prepared from autologous venous blood by low-speed centrifugation at 700 rpm for 3 minutes and injected into periodontal pockets. |
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Change in plaque index (PI) scores assessed at baseline and during follow-up visits. |
| Baseline, 2 weeks, 4 weeks, and 6 weeks |
| Change in gingival index (GI) | Change in gingival index (GI) scores evaluated at baseline and follow-up visits. | Baseline, 2 weeks, 4 weeks, and 6 weeks |
| Change in bleeding on probing (BoP) | Change in bleeding on probing (BoP) assessed at six sites per tooth at baseline and follow-up visits. | Baseline, 2 weeks, 4 weeks, and 6 weeks |
| Change in gingival crevicular fluid (GCF) IL-1β levels | Change in IL-1β levels in gingival crevicular fluid measured using ELISA. | Baseline, 2 weeks, and 6 weeks |
| Change in gingival crevicular fluid (GCF) TNF-α levels | Change in TNF-α levels in gingival crevicular fluid measured using ELISA. | Baseline, 2 weeks, and 6 weeks |
| Change in gingival crevicular fluid (GCF) IL-6 levels | Change in IL-6 levels in gingival crevicular fluid measured using ELISA. | Baseline, 2 weeks, and 6 weeks |
| Change in gingival crevicular fluid (GCF) OPG levels | Change in OPG levels in gingival crevicular fluid measured using ELISA. | Baseline, 2 weeks, and 6 weeks |
| Change in gingival crevicular fluid (GCF) RANKL levels | Change in RANKL levels in gingival crevicular fluid measured using ELISA. | Baseline, 2 weeks, and 6 weeks |