PeriodontitisNCT07146776
Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts
A study testing open flap debridement with I-prf and xenogeneic graft and open flap debridement with saline and xenogenic graft in people with Periodontitis and Intrabony Periodontal Defect, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Intrabony Periodontal Defect, Periodontal Diseases
- What is being tested?
- open flap debridement with I-prf and xenogeneic graft and open flap debridement with saline and xenogenic graft
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jul 2025to 30 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18-65 years
- Patients with Stage III Periodontitis according to the AAP-EFP 2017 Periodontal Disease Classification
- PPD≥5 mm (if persistent 6 weeks after initial periodontal treatment)
- Intrabony defects in the interproximal region with 2 or 3 walls and a depth of at least ≥3 mm
- Non-smokers (those who smoke up to 10 per day may be included)
Who cannot join
- Patients under 18 years of age or older than 65 years of age
- Patients unable to consent
- Systemic diseases that could affect the success of surgery, such as uncontrolled diabetes
- Single-walled intrabony defects
- Those who have taken antibiotics, anti-inflammatory or immunosuppressive drugs, or birth control pills within the three months prior to the study
- Those who have received active periodontal treatment within the last six months and periodontal surgery within the last year
Show all 12Show fewer
- Smoking more than 10 cigarettes per day
- Pregnancy or breastfeeding
- Those taking medications that affect the gums (e.g., calcium channel blockers, phenytoin or cyclosporine)
- Teeth with furcation defects
- Those undergoing active orthodontic treatment
- Those who are allergic to the biomaterials used in the study or prescribed medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sağlık Bilimleri Üniversitesi
Istanbul, Üsküdar
Tuğçe Paksoy, Associate Professor, +905534490452, tugceakap86@hotmai.com
About this study
Official title: Evaluation of the Effect of Injectable Platelet-Rich Fibrin in the Treatment of Periodontal Intrabony Defects With Xenogenic Grafts: a Randomized Controlled Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Periodontitis, Intrabony Periodontal Defect, Periodontal Diseases, Periodontal Defect, Periodontal Bone Loss
- Being tested
- open flap debridement with I-prf and xenogeneic graft, open flap debridement with saline and xenogenic graft
- Keywords
- i-prf, injectable prf, injectable platelet rich fibrin, xenogenic graft, xenogenic bone graft, xenograft
- Medical subject headings
- Periodontitis, Periodontal Diseases, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open flap debridement with I-prf and xenogeneic graftProcedure or surgery
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.
open flap debridement with saline and xenogenic graftProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: open flap debridement with I-prf and xenogeneic graft |
| 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. Receives: Procedure: open flap debridement with saline and xenogenic graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At enrollment, 3 and 6 months control visits
Secondary outcomes (5)
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.
Measured: 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
- A thin layer of plaque is observed along the gingival margin. This thin layer can be detected with a periodontal probe.
- A moderate layer of plaque is observed along the gingival margin. This plaque can be visually detected.
- A considerable layer of plaque is observed at the gingival margin. The interdental spaces appear to be full of plaque.
Measured: 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.
- Mild gingival inflammation, discoloration, and mild edema. No bleeding on probing.
- Moderate gingival inflammation, redness, and edema. Bleeding on probing.
- Severe gingival inflammation, redness, and edema. Spontaneous bleeding occurs.
Measured: 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.
Measured: 2 weeks after the surgical intervention
The Amount of Painkiller Used
The amount of painkiller taken after the operation will be recorded in milligram.
Measured: 2 weeks after the surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start12 Jul 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe Paksoy, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146776
- Sponsor's protocol ID
- 25-19
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No