We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of the Jawbone Anatomy Classification in Endosseous Dental Implant Treatment

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02054676
First Posted: February 4, 2014
Last Update Posted: March 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Universidad de Granada
Hacettepe University
University of Messina
University of Michigan
Information provided by (Responsible Party):
Marius Kubilius, Lithuanian University of Health Sciences
  Purpose

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.

Condition Intervention
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.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validation and Clinical Assessment of Clinical and Radiological Classification of the Jawbone Anatomy in Endosseous Dental Implant Treatment

Resource links provided by NLM:


Further study details as provided by Marius Kubilius, Lithuanian University of Health Sciences:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 80
Study Start Date: February 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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):

  • 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.

Other Names:
  • Ospamox 500mg
  • Dalacin C 300mg
  • Ibuprofen Lannacher 600mg
  • Curasept 0,12% mouth rinse
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.


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. general

    • systematically healthy (American Society of Anaesthesiologists I or II)
    • subject age 18 years or older women and men
    • availability of complete clinical records
    • compliance with all requirements in the study and signing the informed consent
    • absence of allergy to dental implants alloys
  2. local

    • subjects have one or more single limited by neighbouring teeth from both sides edentulous jaw segment
    • the tooth was lost two months or earlier prior the study
    • adjacent edentulous jaw segments have no implant
    • adjacent teeth are intact or have all no defective restorations over cementoenamel junction
    • patient will not wear any kind of removable prosthesis over the treatment area

Exclusion Criteria:

  1. local

    • acute infection at the region of edentulous jaw segment
    • active periodontal diseases
    • current orthodontic or periodontal treatments
    • heavy smokers (more than 10 cigarettes a day)
    • untreated teeth or defective restorations that can potentially exacerbate during the study
    • wisdom tooth edentulous jaw segment or edentulous jaw segment with unerupted tooth
    • central and lateral lower incisors edentulous jaw segments (individual case related treatment planning)
  2. general:

    • pregnancy or lactating mothers
    • history of alcoholism or drug abuse
    • bone disorders (Paget's disease, osteoporosis, or hyperparathyroidism)
    • a history of intravenous (IV) bisphosphonate use
    • neurologic or psychiatric disorders, systemic infections
    • chronic use of medications known to affect the periodontal status (calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications)
    • diseases of the immune system or any medical conditions that may influence the treatment outcome (e.g. uncontrolled diabetes)
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Lithuania
Lithuanian University of Health Sciences
Kaunas, Lithuania, LT-44307
Sponsors and Collaborators
Lithuanian University of Health Sciences
Universidad de Granada
Hacettepe University
University of Messina
University of Michigan
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Marius Kubilius, DDS, Oral Surgeon, PhD Student, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT02054676     History of Changes
Other Study ID Numbers: MC-DS-9-43
First Submitted: February 2, 2014
First Posted: February 4, 2014
Last Update Posted: March 2, 2016
Last Verified: March 2016

Keywords provided by Marius Kubilius, Lithuanian University of Health Sciences:
mandible
alveolar nerve inferior
anatomy
cross-sectional
dental implants
classification
reliability
validity

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action