Validation of the Jawbone Anatomy Classification in Endosseous Dental Implant Treatment

Summary

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.

Expected results.

* 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.

Conditions

• Partially Edentulous Jaw

Interventions

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): * Non aesthetic and aesthetic zone edentulous jaw segment parameters (height, width, length, mandibular canal walls identification/jawbone quality type visual identification) evaluation; * Every edentulous jaw segment parameter should be graded following: Type I (low risk), Type II (moderate risk), Type III (high risk). 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: * implant drill slippage deeper than planned; * implant threads coverage; * etc.

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.

DRUG

Medications.

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.

Sponsors & Collaborators

• Universidad de Granada

  collaborator OTHER

• Hacettepe University

  collaborator OTHER

• University of Messina

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Lithuanian University of Health Sciences

  lead OTHER

Principal Investigators

• Gintaras Juodzbalys, DDS,PhD · Lithuanian University of Health Sciences

• Hom-Lay Wang, DDS,MSD,PhD · University of Michigan

• Marco Cicciu, DDS,MSc,PhD · University of Messina

• Pablo Galindo Moreno, DDS, PhD · Universidad de Granada

• Tolga Fikret Tosum, DDS, PhD · Hacettepe University

• Marius Kubilius, DDS · Lithuanian University of Health Sciences

• Inmaculada Ortega Oller, DDS · Universidad de Granada

• Yagmur Deniz Ilarslan, DDS · Hacettepe University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• Lithuania

Study Locations