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The use of injectable platelet-rich fibrin (i-PRF) in both surgical and non-surgical dental treatments has become increasingly widespread. Hard tissue grafts can produce "sticky bone," and bone gain can have a positive effect on intrabony defects frequently seen in periodontal disease, compared to grafts alone. This study aims to clinically and radiographically evaluate the effectiveness of using bovine-derived xenogenic bone grafts in combination with i-PRF and bovine-derived xenogeneic bone grafts alone in patients with intrabony defects and stage III periodontitis.
Intrabony defects are frequently observed in periodontitis patients. Bovine-derived xenogenic grafts are widely used in their treatment. To date, the graft has been mixed with various materials to increase its regenerative efficacy. In recent years, studies have explored its use in combination with PRF derivatives. Furthermore, with the introduction of i-PRF in regenerative treatments, its application with various biomaterials has been attempted. Applications have been made with materials such as demineralized freeze-dried bone allografts, hydroxyapatite bone grafts, and nanohydroxyapatite, with successful results. However, no studies have been conducted to date on the application of i-PRF with bovine-derived xenogeneic grafts in intrabony periodontal defects. This study aims to demonstrate that bovine-derived xenogeneic graft materials, which are frequently preferred by patients, achieve more successful results in various clinical and radiographic parameters in the treatment of intrabony defects, thanks to the contribution of i-PRF. The aims are to reduce clinical parameters that favor the treatment, increase bone fill, and minimize the defect area. It is thought that the use of I-PRF, a tissue-friendly biological material, will contribute to positive results in these parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| i-PRF and xenogenic graft | Experimental | In this treatment protocol, bone graft and i-PRF will be used instead of physiological saline. The preparation time for i-PRF (centrifugation) is 3 minutes. Two 9-mL tubes of venous blood will be collected from each patient. |
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| Saline and xenogenic graft | Active Comparator | A bovine-derived xenogeneic bone graft, which is routinely used for the treatment of intraosseous defects, will be applied. The graft will be mixed with physiological saline prior to application. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open flap debridement with I-prf and xenogeneic graft | Procedure | During the surgical phase of treatment, patients will undergo open flap debridement surgery. Infiltrative local anesthesia will first be administered to the involved teeth. The gingiva will be incised within the gingival sulcus using a scalpel, and a full-thickness flap will be carefully elevated with a periosteal elevator. Granulation tissue and dental calculus will be completely removed using Gracey curettes (American Eagle, USA) and an ultrasonic scaler. Subsequently, a xenogeneic bone graft mixed with injectable platelet-rich fibrin (i-PRF) will be applied. The flap will then be sutured using 4-0 polypropylene sutures. |
| Measure | Description | Time Frame |
|---|---|---|
| Intrabony Defect Fill | The change in the defect size will be evaluated using computed tomography. Slices with a thickness of 1.0 mm will be acquired in the sagittal plane. The defect base, alveolar bone crest, and cementoenamel junction (CEJ) will be identified on the images, and the distances between these anatomical landmarks will be measured in millimeters. The distance between the defect base and the alveolar bone crest will be used to determine the depth of the intraosseous defect. | At enrollment and 6 months control visit |
| Clinical Attachment Level | It represents the value obtained by measuring the distance between the pocket base and the cementoenamel junction (CEJ) using a standard periodontal probe with a diameter of 0.4-0.5 mm, rounded to the nearest millimeter. The changes in clinical attachment level will be measured at baseline, as well as at the 3- and 6-month follow-up visits. | At enrollment, 3 and 6 months control visits |
| Measure | Description | Time Frame |
|---|---|---|
| Probing Pocket Depth | Probing pocket depth, defined as the distance between the base of the periodontal pocket and the free gingival margin, is one of the important clinical parameters used to monitor tissue healing after periodontal treatments. It will be measured in mm from the six surfaces of the involved tooth (buccal mesial, buccal middle, buccal distal, palatal/lingual mesial, palatal/lingual middle, and palatal/lingual distal) using a Williams or UNC-15 periodontal probe. Changes in probing pocket depth will be recorded at baseline, as well as at the 3- and 6-month follow-up visits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tuğçe Paksoy, Associate Professor | Contact | +905534490452 | tugceakap86@hotmai.com | |
| Alima Budakçı | Contact | +905319841597 | alima-97@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sağlık Bilimleri Üniversitesi | Recruiting | Istanbul | Üsküdar | Turkey (Türkiye) |
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| open flap debridement with saline and xenogenic graft | Procedure | During the surgical phase of treatment, patients will undergo open flap debridement surgery. Infiltrative local anesthesia will first be administered to the involved teeth. The gingiva will be incised within the gingival sulcus using a scalpel, and a full-thickness flap will be carefully elevated with a periosteal elevator. Granulation tissue and dental calculus will be thoroughly removed using Gracey curettes (American Eagle, USA) and an ultrasonic scaler. A xenogeneic bone graft mixed with physiological saline will then be applied. Finally, the flap will be sutured using 4-0 polypropylene sutures. |
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| At enrollment, 3 and 6 months control visits |
| Plaque Index | Patients' plaque indices will be recorded according to the Silness & Löe Index. After the teeth are air-dried, the amount of plaque near the gingival margin of each tooth will be examined with an inspection and a periodontal probe. Index values ranging from 0 to 3 are assigned based on the amount of plaque on the tooth surface. Based on this index: 0: No plaque
| At enrollment, 3 and 6 months control visits |
| Gingival Index | This index was developed by Löe & Silness. This system evaluates bleeding, the most fundamental sign of inflammation. The mesial, distal, vestibular, and lingual gingiva of the teeth are evaluated. They are scored from 0 to 3. These values are then summed and divided by four. This calculates the gingival index. Dividing the total by the number of teeth yields the individual score. According to this index: 0: Healthy gingiva, no inflammation.
| At enrollment, 3 and 6 months control visits |
| Pain Assasment | The Visual Analog Scale (VAS) is the most commonly used scale for both measuring pain intensity and monitoring the degree of pain relief. The VAS consists of a 10-cm line with endpoints of "no pain" and "worst possible pain." The patient marks the line that best describes their pain intensity. The average of the obtained values is calculated for each patient. The patient's pain, inability to chew, and procedural stress will be assessed with the VAS at two weeks postoperatively. | 2 weeks after the surgical intervention |
| The Amount of Painkiller Used | The amount of painkiller taken after the operation will be recorded in milligram. | 2 weeks after the surgical intervention |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| C043309 | proliferation regulatory factors, human urine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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