Inonu University Faculty of Dentistry
Malatya, Battalgazi, 44280, Turkey (Türkiye)
NCT Number: NCT07415148
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
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Notify Me30 year–60 year
All sexes
Interventional
Not applicable
Malatya, Battalgazi, 44280, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Scaling and Root Planing
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.
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.
Other names: Hyaluronic acid (HA), HA gel
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1. month and 3. months
Changes in probing pocket depth (PPD) measured in millimeters (mm) will be evaluated.
Time frame: Baseline, 1. month and 3. months
Changes in plaque index scores will be evaluated.
Time frame: Baseline, 1. month and 3. months
Changes in gingival index scores will be evaluated.
Time frame: 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.
Time frame: Baseline, 1. month and 3. months
Changes in clinical attachment level (CAL) measured in millimeters (mm) will be evaluated.
Inonu University
Other
Evaluation of the Effects of Hyaluronic Acid and Albumin-PRF as Adjuncts to Non-Surgical Periodontal Treatment on Clinical and Biochemical Parameters
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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