An interventional study of open flap debridement with I-prf and xenogeneic graft and open flap debridement with saline and xenogenic graft in Periodontitis, Intrabony Periodontal Defect and Periodontal Diseases, sponsored by Saglik Bilimleri Universitesi. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Treatment
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 16 is below the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: open flap debridement with I-prf and xenogeneic graft
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.
Procedure: open flap debridement with saline and xenogenic graft
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.
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.
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.
Time frame: 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.
Time frame: At enrollment, 3 and 6 months control visits
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.
Time frame: 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 1. A thin layer of plaque is observed along the gingival margin. This thin layer can be detected with a periodontal probe. 2. A moderate layer of plaque is observed along the gingival margin. This plaque can be visually detected. 3. A considerable layer of plaque is observed at the gingival margin. The interdental spaces appear to be full of plaque.
Time frame: 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. 1. Mild gingival inflammation, discoloration, and mild edema. No bleeding on probing. 2. Moderate gingival inflammation, redness, and edema. Bleeding on probing. 3. Severe gingival inflammation, redness, and edema. Spontaneous bleeding occurs.
Time frame: 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.
Time frame: 2 weeks after the surgical intervention
The Amount of Painkiller Used
The amount of painkiller taken after the operation will be recorded in milligram.
Time frame: 2 weeks after the surgical intervention
Started Jul 2025 (actual). Primary completion is estimated for Dec 2026, 16 months after the start.
Of 480 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 16 months is close to that.
Counting every sponsor, half of 494 studies reached it within 16 months; a quarter within 8 and three quarters within 31.
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