MIST with PRF versus GBT (with or without PRF) for treating a single deep intrabony periodontal defect
Comparison of Minimally Invasive Surgical Therapy in Combination With Platelet Rich Fibrine and Guided Biofilm Therapy Combined With Platelet Rich Fibrine in the Treatment of Solitaire Intrabony Periodontal Defect A Prospective RCT.
This trial tests whether adding platelet-rich fibrin (PRF) to a minimally invasive surgical approach (MIST) or to guided biofilm therapy (GBT) improves healing of a single deep intrabony periodontal defect in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Locations | 1 site (Budapest, Budapest) |
| Trial ID | NCT06768424 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized controlled trial that enrolls adults with a solitary intrabony defect ≥4 mm and randomizes them to three arms: GBT alone (control), non-surgical GBT with PRF placed into the cleaned defect, or MIST with PRF placed after flap access. Clinical periodontal parameters are recorded at baseline and at six months and standardized radiographs are taken at six months to measure bone changes. The primary outcome is the change in clinical attachment level (delta CAL) at six months, with radiographic bone fill and standard clinical measures as secondary outcomes. Key eligibility includes good oral hygiene, low plaque and bleeding scores, minimal smoking, and no furcation involvement.
Who should consider this trial
Good fit: Ideal candidates are adults with a single intrabony periodontal defect of at least 4 mm, good oral hygiene (FMPS/FMBS <15%), light or non-smokers, no furcation involvement, and able to attend follow-up visits and give informed consent.
Not a fit: Patients with multiple or complex defects (for example steep defect angulation >25°), significant furcation involvement, poor oral hygiene, heavy smoking, or inability to attend follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could increase attachment gain and bone fill and may allow some patients to avoid more extensive surgery.
How similar studies have performed: Prior studies have shown favorable results for PRF and for minimally invasive surgical techniques in periodontal regeneration, but placing PRF without flap access is less well established and direct comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * solitaire intrabony periodontal defect at least 4 mm Exclusion Criteria: * Periodontitis with intrabony defect (Intrabony component ≥ 4mm, defect radiological angulation \> 25°, * The patient is able to comply with the study -related procedures (i.e. good level of oral hygiene, follow-up procedures). * Patients must not be heavy smokers (\<5 cigarettes/day). * furcation involvement * Full mouth plaque and bleeding scores (FMPS and FMBS) of \<15% (O'Leary et al. 1972). * The patient is able to fully understand the nature of the study, signed informed consent.
Where this trial is running
Budapest, Budapest
- Semmelweis University Department of Periodontology — Budapest, Budapest, Hungary (Recruiting)
Study contacts
- Study coordinator: Pál Nagy, DMD
- Email: kardpali@gmail.com
- Phone: +3613185222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.