Periodontitis, Periodontal Inflammation
Conditions
Keywords
Periodontal Disease, Hyaluronic Acid, Albumin Platelet-Rich Fibrin, Scaling and Root Planing
Brief summary
Periodontitis is a chronic inflammatory disease that leads to the destruction of the supporting tissues of the teeth. Non-surgical periodontal treatment is the first-line approach for the management of periodontitis; however, the use of adjunctive therapeutic agents may improve clinical outcomes. The aim of this randomized clinical trial is to evaluate the effects of hyaluronic acid gel and albumin platelet-rich fibrin (Alb-PRF) used as adjuncts to non-surgical periodontal treatment on clinical and biochemical parameters in patients with Stage III periodontitis. Participants will be randomly allocated into three groups: an Alb-PRF group, a hyaluronic acid gel group, and a control group receiving non-surgical periodontal treatment alone. Clinical periodontal parameters and biochemical markers obtained from gingival crevicular fluid will be assessed at baseline and at 1 and 3 months after treatment. The findings of this study are expected to contribute to the evaluation of the potential benefits of adjunctive biological and anti-inflammatory applications in the non-surgical periodontal treatment of patients with Stage III periodontitis.v
Detailed description
This study is designed as a randomized, parallel-group clinical trial conducted in patients diagnosed with Stage III periodontitis. The aim of the study is to evaluate the adjunctive effects of hyaluronic acid gel and albumin platelet-rich fibrin (Alb-PRF) when used in addition to non-surgical periodontal treatment. A total of 51 systemically healthy volunteers will be included in the study. Participants will be randomly allocated into three groups (17 patient per group). At the initial visit, all participants will undergo clinical periodontal examination, intraoral photography, and gingival crevicular fluid sampling. Supragingival scaling will be performed for all patients at baseline. One week later, full-mouth scaling and root planing will be completed in a single session. In the Alb-PRF group, albumin platelet-rich fibrin will be applied as an adjunctive therapy. In the hyaluronic acid group, hyaluronic acid gel will be applied following scaling and root planing and the application will be repeated at the second week. The control group will receive non-surgical periodontal treatment alone without any adjunctive application. Adjunctive treatments will be applied subgingivally immediately after periodontal therapy and one week later. To evaluate clinical and biochemical outcomes, clinical periodontal parameters and gingival crevicular fluid samples will be collected at baseline and at 1 and 3 months after treatment. Gingival crevicular fluid samples will be obtained using sterile paper strips as a non-invasive method. All collected data will be evaluated at the end of the study. The results of this study are expected to provide additional evidence regarding the effectiveness of adjunctive biological and anti-inflammatory approaches in the non-surgical treatment of Stage III periodontitis.
Interventions
PROCEDURENon-Surgical Periodontal Treatment
Supragingival scaling was performed at baseline. One week later, full-mouth scaling and root planing were completed in a single session using standard periodontal instruments.
OTHERAlbumin Platelet-Rich Fibrin (Alb-PRF)
Albumin platelet-rich fibrin (Alb-PRF) was applied subgingivally as an adjunctive therapy immediately after non-surgical periodontal treatment, with a second application performed one week later.
OTHERHyaluronic Acid Gel
Hyaluronic acid gel was applied subgingivally as an adjunct to non-surgical periodontal treatment immediately after the procedure, with a second application performed one week later.
Sponsors
Inonu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a three-arm, randomized, parallel-group clinical trial evaluating non-surgical periodontal therapy alone versus adjunctive hyaluronic acid gel or albumin platelet-rich fibrin (Alb-PRF) in patients with Stage III periodontitis
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Systemically healthy individuals aged between 30 and 60 years * No history of periodontal treatment or antibiotic use within the last 6 months * Non-smokers * Accepting to regularly attend the follow-up sessions planned during the study period * Diagnosis of Stage III periodontitis * Presence of at least 15 teeth in the oral cavity, with more than 30% of the existing teeth affected by periodontal disease * Presence of probing pocket depth ≥6 mm and clinical attachment loss ≥5 mm in affected teeth * Presence of vertical bone loss ≥3 mm * Radiographic evidence of alveolar bone loss extending to the middle third or beyond (≥33%) of the root length in affected teeth
Exclusion criteria
* Presence of any systemic disease * History of periodontal treatment or antibiotic use within the last 6 months * Pregnancy or lactation * Presence of acute oral lesions or necrotizing ulcerative periodontitis * Use of medications known to affect periodontal tissues * Current smoking * Presence of immune system disorders or use of immunosuppressive medications * Presence of prosthetic restorations on teeth selected for gingival crevicular fluid sampling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gingival Crevicular Fluid VEGF Levels | Baseline, 1. month and 3. months | Changes in vascular endothelial growth factor (VEGF) levels in gingival crevicular fluid will be analyzed to evaluate angiogenic activity. |
| Change in Gingival Crevicular Fluid IL-1 Beta Levels | Baseline, 1. month and 3. months | Changes in interleukin-1 beta (IL-1β) levels in gingival crevicular fluid will be assessed as a marker of inflammation. |
| Change in Gingival Crevicular Fluid IL-10 Levels | Baseline, 1. month and 3. months | Changes in interleukin-10 (IL-10) levels in gingival crevicular fluid will be evaluated to assess anti-inflammatory response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Pocket Depth | Baseline, 1. month and 3. months | Changes in probing pocket depth (PPD) measured in millimeters (mm) will be evaluated. |
| Change in Plaque Index | Baseline, 1. month and 3. months | Changes in plaque index scores will be evaluated. |
| Change in Gingival Index | Baseline, 1. month and 3. months | Changes in gingival index scores will be evaluated. |
| Change in Bleeding on Probing | Baseline, 1 month and 3 months | Changes in bleeding on probing (BOP), expressed as the percentage of bleeding sites (%), will be evaluated as an indicator of gingival inflammation. |
| Change in Clinical Attachment Level | Baseline, 1. month and 3. months | Changes in clinical attachment level (CAL) measured in millimeters (mm) will be evaluated. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORFurkan Kuşoğlu
Inonu University, Department of Periodontology Faculty of Dentistry
STUDY_CHAIRArife Sabancı, Dr
Inonu University, Department of Periodontology Faculty of Dentistry
Outcome results
None listed