Bone healing after root-end microsurgery using a rotary bur versus a piezoelectric device
Prospective Healing Assessment After Application of Endodontic Microsurgery for Elimination of Apical Pathology By Use of Either a Rotary Bur for Osteotomy and Apical Root Resection, or Piezoelectric Unit for the Same Clinical Procedures
NA · National and Kapodistrian University of Athens · NCT07197658
This test will see if adults with persistent root infection heal better when bone and the root tip are cut with a rotary bur or with a piezoelectric device.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National and Kapodistrian University of Athens (other) |
| Locations | 2 sites (Athens, Attica and 1 other locations) |
| Trial ID | NCT07197658 on ClinicalTrials.gov |
What this trial studies
This prospective comparison enrolls adults undergoing apical microsurgery for periapical periodontitis and compares bone and root resection using rotary burs versus a piezoelectric unit. A predefined subgroup with intact buccal cortical bone will receive a piezoelectric 'bone window' preservation technique to compare buccal bone reformation. Healing and buccal bone thickness are measured with baseline and follow-up CBCT imaging, including at least one CBCT at 12 months. The main outcomes are radiographic bone healing and buccal bone thickness reformation between the techniques.
Who should consider this trial
Good fit: Adults (≥18) with prior root canal treatment and radiographic apical periodontitis, lesion size ≤10 mm on CBCT, an intact coronal restoration, and ASA I–II medical status are the ideal candidates.
Not a fit: Patients with lesions >10 mm, nonrestorable or traumatized teeth, tooth mobility grade I or higher, advanced medical comorbidities (ASA III–V), or microsurgical classifications D–F are excluded and unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the results could identify the technique that leads to better bone healing and buccal bone preservation, helping clinicians choose methods that improve long-term tooth stability after microsurgery.
How similar studies have performed: Prior literature indicates piezoelectric bone cutting can reduce soft-tissue trauma and aid bone preservation, but direct head-to-head evidence in apical microsurgery and for the 'bone window' technique is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years and older consenting to the surgical procedure as well as agreeing to preoperative, postoperative and at least one follow-up CBCT evaluation after 12 months * Noncontributory medical history (American Society of Anesthesiologists class I and II) * A history of previous endodontic treatment with radiographic presence of apical periodontitis * A true endodontic lesion: microsurgical classification A, B, or C according to Kim and Kratchman, 2006. * Lesion size 10 mm or smaller in diameter measured on preoperative CBCT * Coronal restoration should be present at the time of follow up examination. Exclusion Criteria: * Nonconsenting patients and patients younger than 18 years of age * Medical history with American Society of Anesthesiologists class III to V * Insufficient coronal restoration * Nonrestorability or traumatized teeth * Teeth with microsurgical classification D, E, or F according to Kim and Kratchman, 2006. * Mobility I or higher * Radiographic presence of nonapical root resorption * Teeth with a vertical root fracture or coronal/ midroot perforation * Lesion size larger than 10 mm in diameter measured on preoperative CBCT * Use of bone graft material for regeneration
Where this trial is running
Athens, Attica and 1 other locations
- Private Dental Office — Athens, Attica, Greece (RECRUITING)
- Spyros Floratos Private Dental Office — Athens, Attica, Greece (RECRUITING)
Study contacts
- Study coordinator: Spyros Floratos, DMD, PhDCand
- Email: sflo_@hotmail.com
- Phone: +30 697 745 8959
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.
Conditions: Periapical Periodontitis, Endodontic Microsurgery, Osteotomy, Endodontic surgery, Piezosurgery, Bone window