Validation of the Jawbone Anatomy Classification in Endosseous Dental Implant Treatment
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|ClinicalTrials.gov Identifier: NCT02054676|
Recruitment Status : Unknown
Verified March 2016 by Marius Kubilius, Lithuanian University of Health Sciences.
Recruitment status was: Enrolling by invitation
First Posted : February 4, 2014
Last Update Posted : March 2, 2016
The purpose of this study is to evaluate validation and clinical assessment of the earlier proposed clinical and radiological classification of the jawbone anatomy in endosseous dental implant treatment.
- high accuracy of proposed classification for proper implantation risk degree evaluation.
- the proposed classification system based on anatomical and radiological jawbone quantity and quality evaluation will be a helpful tool for planning of treatment strategy and collaboration among specialists.
- good interobserver reliability of clinical and radiological edentulous jaw segment evaluation.
- good reliability between radiological and intraoperative investigations and postoperative data.
|Condition or disease||Intervention/treatment||Phase|
|Partially Edentulous Jaw||Radiation: Cone-Beam Computed Tomography preoperative evaluation. Procedure: Intraoperative edentulous jaw segment parameters evaluation. Device: Endosseous dental implant placement. Radiation: Dental implant position evaluation. Drug: Medications. Procedure: Late postoperative soft tissue evaluation.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation and Clinical Assessment of Clinical and Radiological Classification of the Jawbone Anatomy in Endosseous Dental Implant Treatment|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2016|
Experimental: Classification assessment.
Random group of the partially edentulous individuals will be assessed according to prepared classification evaluation protocol during dental implant treatment period. Cone-beam computed tomography preoperative evaluation will be made during preoperative stage. Intraoperative edentulous jaw segment parameters evaluation, endosseous dental implant placement parameters assessment during intraoperative stage will be made. Dental implant position evaluation during early postoperative stage will be made. Medications will be prescribed. Late postoperative soft tissue evaluation of edentulous jaw segment will be made during final crown placement. Cone-beam computed tomography analysis results will be compared with subsequent stages assessment results to evaluate reliability of the classification.
Radiation: Cone-Beam Computed Tomography preoperative evaluation.
Procedure: Cone-beam computed tomography (CBCT) preoperative evaluation (e.g. "i-CAT", Imaging Sciences International, Hatfield, Pennsylvania, USA). CBCT voxel size is about 0,2 - 0,25 mm . Manufacturer recommended software is used. CBCT evaluation of partially edentulous jaw segments are made during preoperative stage (see Appendix 1):
All graded measurements provide overall risk evaluation for implant treatment in non aesthetic and aesthetic zone without aesthetic parameters evaluation. Dental implant is selected if surgery is possible.
Procedure: Intraoperative edentulous jaw segment parameters evaluation.
Surgery is planned preliminary according to preoperative stage edentulous jaw segment evaluation results.
Intervention related study parameters are provided on Appendix 2. Aesthetic parameters related to implant treatment success are evaluated after mucoperiosteal flap elevation: alveolar ridge vertical position, mesial and distal interproximal bone peak height (in the aesthetic zone).
The additional parameters (non aesthetic) are evaluated after dental implant osteotomy preparation and implant placement:
Device: Endosseous dental implant placement.
Endosseous dental implant (e.g. "Bone Level SLA" implant, Straumann AG, Basel, Switzerland) is placed if possible during intraoperative stage according to study protocol in the aesthetic or non aesthetic zone edentulous jaw segment. Optimally positioned dental implant is surrounded by at least 1 mm of bone for successful treatment outcome in the non aesthetic zone.
Aesthetic zone implant is placed in the optimal three dimensional position. It is surrounded by bone at least 1 mm from lingual side and at least 2 mm from buccal side for successful treatment outcome.
Dental implant apex is at least 2 mm away from anatomically important jaw vital structures.
Dental implant parameters (length, width) are individual (depends on edentulous jaw segment parameters).
Bone and soft tissue augmentation are made if necessary after dental implant placement.
Radiation: Dental implant position evaluation.
Periapical radiograph (e.g. "Kodak RVG 6100 Intraoral Digital Imaging System", Carestream Health, Rochester, NY) evaluation is necessary (Appendix 2) to examine implant apex distance to anatomically important vital structures (possible injury) (mandibular canal, nose base) during early postoperative stage.
Digital periapical radiographs are used to assess the edentulous jaw segment after implant placement. The long cone paralleling technique should be used for taking periapical X-ray (prevention of possible creation of foreshortening and elongation).
Postoperative patient's neurosensory evaluation is necessary to assess possible inferior alveolar nerve and lingual nerve injury. After finishing of local anaesthesia patient should be contacted and if there are some sensory deficit complains, patient should be examined.
Patients will be given amoxicillin 500mg for every 8 hours or clindamycin 300mg for every 8 hours for 7 - 10 days after surgery.
Patients will be given Ibuprofen 600mg every 12 hours for pain relief following surgery at least for first three days as needed.
Patients will be given chlorhexidine 0,12% mouth rinse at least every 8 hours starting 24 hours after surgery for 14 days.
Procedure: Late postoperative soft tissue evaluation.
Mesial and distal papillae appearance, vertical soft tissue deficiency (Appendix 3) evaluation during late postoperative stage is necessary for classification accuracy assessment during final single-tooth implant crown placement in the region of aesthetic zone (both parameters are evaluated) and non aesthetic zone (soft tissue vertical deficiency) edentulous jaw segment.
The time after surgery is case depending before provisional and final crown placement.
Peri-implant soft tissue conditioning is recommended with screw retained provisional single-tooth implant crown for approximately 4 - 8 weeks.
Healing abutment placement after dental implant osseointegration is not recommended because of the treatment time saving.
- Number of patients with proper clinical diagnosis based on classification [ Time Frame: One year ]Number of patients with proper diagnosis represent reliability of the classification
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054676
|Lithuanian University of Health Sciences|
|Kaunas, Lithuania, LT-44307|
|Study Chair:||Gintaras Juodzbalys, DDS,PhD||Lithuanian University of Health Sciences|
|Study Chair:||Hom-Lay Wang, DDS,MSD,PhD||University of Michigan|
|Principal Investigator:||Marco Cicciu, DDS,MSc,PhD||University of Messina|
|Principal Investigator:||Pablo Galindo Moreno, DDS, PhD||Universidad de Granada|
|Principal Investigator:||Tolga Fikret Tosum, DDS, PhD||Hacettepe University|
|Principal Investigator:||Marius Kubilius, DDS||Lithuanian University of Health Sciences|
|Principal Investigator:||Inmaculada Ortega Oller, DDS||Universidad de Granada|
|Principal Investigator:||Yagmur Deniz Ilarslan, DDS||Hacettepe University|