Endodontic Microsurgery, Osteotomy, Periapical Periodontitis
Conditions
Keywords
Endodontic surgery, Piezosurgery, Bone window
Brief summary
The goal of this clinical trial is to compare bone healing after using apical tooth microsurgery to remove root end infection, either by use of rotary burs for cutting bone and root end, or by use of piezoelectric surgery for the same procedures. The main questions it aims to answer are: * Is there a difference in bone healing and reformation between the two surgical procedures ? * Is there a difference in bone healing between cutting the bone with a rotary bur and cutting the bone with the 'bone window' technique that uses piezoelectric unit ?
Detailed description
The aim of this study is to prospectively compare postsurgical healing after the use of microsurgical technique to eliminate apical pathology, either by use of rotary burs for osteotomy and root resection, or by use of piezoelectric surgery for the same clinical procedures. Null hypothesis is that there is no difference in healing and buccal bone thickness reformation between the two surgical procedures Another purpose of the study is to prospectively evaluate healing after the application of a novel buccal bone preservation technique, called the 'bone window' technique. The technique will be applied in a subgroup of patients on maxillary and mandibular premolar and molar teeth with an intact buccal cortical bone and healing and buccal bone reformation will be assessed at follow up. Null hypothesis in this part, is that there is no difference in healing and buccal bone preservation between osteotomy with a bur and the 'bone window' technique.
Interventions
PROCEDUREendodontic microsurgery / rotary bur osteotomy
Endodontic microsurgery will be executed by use of a rotary bur
PROCEDUREEndodontic microsurgery / piezo osteotomy
Endodontic microsurgery will be performed by use of a piezosurgery unit
PROCEDUREEndodontic microsurgery / bone window
'Bone window' technique will be performed by use of piezoelectric surgery
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
For this prospective investigation, patients will be randomly allocated into two groups. In the experimental group, endodontic microsurgery will be performed by use of a rotary bur for osteotomy and apical root resection. In the control group, piezoelectric surgery will be used for the same clinical procedures. All surgical procedures will be performed by one operator. Postsurgical healing as well as certain preoperative and postoperative parameters will be assessed and compared in the two groups. In a subgroup of patients having at least 2mm of intact buccal cortical bone thickness preoperatively, piezoelectric surgery will be used to prepare a rectangular buccal 'bone window'. The buccal bone thickness will be measured preoperatively on the coronal slices of the Cone Beam Computed Tomography (CBCT). After completing the root end filling, the bone window will be repositioned at the original position
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two dimensional radiographic bone healing | From execution of the microsurgical procedure to one year or later follow up examination | Bone healing will be measured on periapical radiograph using well established two dimensional criteria for bone healing assessment. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing |
| Three dimensional radiographic bone healing | From execution of the microsurgical procedure to one year or later follow up examination | Bone healing will be measured on Cone Beam Computed Tomography (CBCT) scan using well established three dimensional criteria for bone healing assessment. Penn 3D criteria categorize healing using CBCT scans into three categories: complete healing, limited and unsatisfactory healing |
Countries
Greece
Contacts
STUDY_DIRECTORApostolos Tsolakis, DMD,MS,PhD
National and Kapodistrian University of Athens
Outcome results
None listed