An interventional study of Access Flap and Close Surgical Technique in Intrabony Periodontal Defect, Treatment and Residual, sponsored by Aristotle University Of Thessaloniki. Recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Aristotle University Of Thessaloniki · Not applicable, Interventional, and Treatment
A pioneer periodontal surgical approach employing the closed surgical technique (CST) has been designed to gain access to isolated interdental periodontal defects and retain the soft-tissue architecture. This technique is based on a modified tunnelling technique to retract full-thickness gingival flaps from the osseous defect in a closed manner retaining intact the interproximal papilla thus, suturing is not required. A randomized controlled clinical trial will determine the efficacy of the CST combined with i-PRF versus the modified papilla preservation technique (MPPT) combined with i-PRF over a period of 12 months
This randomized controlled clinical trial will compare the CST combined with i-PRF over the papilla preservation technique (MPPT) combined with i-PRF to treat isolated interdental defects in terms of gain in clinical attachment levels, radiographic evidence of bone apposition and local reduction of biomarkers (VEGF, OPG, RANKL) over a period of 12 months. For the preparation of i-PRF, 20 mL of venous blood is initially collected from each patient under aseptic conditions. The blood samples are then immediately centrifuged at a relative centrifugal force of 700 × g for 8 minutes.
130 studies on the registry are indexed under Periodontal Pocket; 35 are open to participants now.
This study's planned enrollment of 40 is above the median of 30 across 113 interventional studies indexed under Periodontal Pocket.
Browse Periodontal Pocket studies →Aristotle University Of Thessaloniki is the lead sponsor of 282 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Group A Intrasulcular incisions at the teeth adjacent to the defect, using the modified papilla preservation technique (MPPT). Granulation tissue is excised and debridement via hand and power-driven instruments follows. Flaps are repositioned and papilla are sutured with horizontal internal mattress doubled by a single interrupted interdental suture.
Procedure: Access Flap
Experimental: Group B Strictly intrasulcular incisions are performed at the teeth adjacent to the defect (mid-buccal to mid-lingual) without incising the interdental papilla. Full thickness gingival flaps, at the base of the papilla, which is retained intact, are elevated in a "closed"-tunneling manner, granting access to the interdental osseous defect. Debridement is performed via power-driven tips and mini curettes, without intentional excising the granulation tissue that lines the osseous defect. Flaps are repositioned by gentle pressure and suturing is not required.
Procedure: Close Surgical Technique
Procedure/Surgery: Access Flap Intrasulcular incisions at the teeth adjacent to the defect, using the modified papilla preservation technique (MPPT). Granulation tissue is excised and debridement via hand and power-driven instruments follows. Autologous injectable platelet-rich fibrin (i-PRF) is prepared by centrifugation and then injected into the periodontal intrabony defect as an autologous bioactive adjunct to surgical treatment. Flaps are repositioned and papilla are sutured with horizontal internal mattress doubled by a single interrupted interdental suture.
Strictly intrasulcular incisions are performed at the teeth adjacent to the defect (mid-buccal to mid-lingual) without incising the interdental papilla. Full thickness gingival flaps, at the base of the papilla, which is retained intact, are elevated in a "closed"-tunneling manner, granting access to the interdental osseous defect. Debridement is performed via power-driven tips and mini curettes, without intentionally excising the granulation tissue that lines the osseous defect. Autologous injectable platelet-rich fibrin (i-PRF) is prepared by centrifugation and then injected into the periodontal intrabony defect as an autologous bioactive adjunct to surgical treatment. Flaps are repositioned by gentle pressure and suturing is not required.
Clinical Attachment Level
Determined by a manual periodontal probe(Hu-Friedy XP-23/QW) by a single examiner at the nearest of 1mm
Time frame: baseline to 12 months
Cementoenamel junction to Bottom of the defect
Determined on standardized periapical radiographs obtained by the long cone parallel technique
Time frame: baseline to 12 months
Probing Pocket Depth
Determined by a manual periodontal probe
Time frame: baseline to 12 months
Recession
Determined by a manual periodontal probe
Time frame: baseline to 12 months
Reduction of biomarkers (VEGF, OPG, RANKL)
Determined by ELISA in GCF
Time frame: baseline to 12 months
Bleeding on Probing
Determined by a manual periodontal probe
Time frame: baseline to 12 months
Patient satisfaction and perception
Determined on questionnaires
Time frame: 2 weeks following surgery
Plan to share: No — Overall data but not on an individual basis will be disclosed and shared
Started Oct 2026 (actual). Primary completion is estimated for Jul 2028, 21 months after the start.
Of 59 non-industry interventional studies with no phase under Periodontal Pocket, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 26. This study's planned 21 months is above that.
Counting every sponsor, half of 63 studies reached it within 16 months; a quarter within 9 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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