Validation of the Jawbone Anatomy Classification in Endosseous Dental Implant Treatment

NCT02054676 | Unknown

• 1 other identifier: MC-DS-9-43
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mandible; alveolar nerve inferior; anatomy; cross-sectional; dental implants; classification; reliability; validity

Outcome Measures

Primary Outcomes (1)

• Number of patients with proper clinical diagnosis based on classification

  Number of patients with proper diagnosis represent reliability of the classification

  One year

Study Arms (1)

Classification assessment.

EXPERIMENTAL

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: Intraoperative edentulous jaw segment parameters evaluation.; Device: Endosseous dental implant placement.; Radiation: Dental implant position evaluation.; Drug: Medications.; Procedure: Late postoperative soft tissue evaluation.

Interventions

Cone-Beam Computed Tomography preoperative evaluation. RADIATION

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.

Classification assessment.

Intraoperative edentulous jaw segment parameters evaluation. PROCEDURE

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.

Classification assessment.

Endosseous dental implant placement. DEVICE

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.

Classification assessment.

Dental implant position evaluation. RADIATION

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.

Classification assessment.

Medications. DRUG

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.

Also known as: Ospamox 500mg, Dalacin C 300mg, Ibuprofen Lannacher 600mg, Curasept 0,12% mouth rinse

Classification assessment.

Late postoperative soft tissue evaluation. PROCEDURE

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.

Classification assessment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Universidad de Granada: collaborator
• Hacettepe University: collaborator
• University of Messina: collaborator
• University of Michigan: collaborator

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, LT-44307, Lithuania

Location

Related Publications (5)

• Juodzbalys G, Kubilius M. Clinical and radiological classification of the jawbone anatomy in endosseous dental implant treatment. J Oral Maxillofac Res. 2013 Jul 1;4(2):e2. doi: 10.5037/jomr.2013.4202.

  PMID: 24422030 BACKGROUND

• Raes F, Renckens L, Aps J, Cosyn J, De Bruyn H. Reliability of circumferential bone level assessment around single implants in healed ridges and extraction sockets using cone beam CT. Clin Implant Dent Relat Res. 2013 Oct;15(5):661-72. doi: 10.1111/j.1708-8208.2011.00393.x. Epub 2011 Oct 18.

  PMID: 22008055 BACKGROUND

• Juodzbalys G, Wang HL. Identification of the mandibular vital structures: practical clinical applications of anatomy and radiological examination methods. J Oral Maxillofac Res. 2010 Jul 1;1(2):e1. doi: 10.5037/jomr.2010.1201. eCollection 2010.

  PMID: 24421966 BACKGROUND

• Juodzbalys G, Wang HL, Sabalys G, Sidlauskas A, Galindo-Moreno P. Inferior alveolar nerve injury associated with implant surgery. Clin Oral Implants Res. 2013 Feb;24(2):183-90. doi: 10.1111/j.1600-0501.2011.02314.x. Epub 2011 Nov 1.

  PMID: 22092662 BACKGROUND

• Juodzbalys G, Wang HL. Esthetic index for anterior maxillary implant-supported restorations. J Periodontol. 2010 Jan;81(1):34-42. doi: 10.1902/jop.2009.090385.

  PMID: 20059415 BACKGROUND

Related Links

• Click here for more information about this study: Clinical and Radiological Classification of the Jawbone Anatomy in Endosseous Dental Implant Treatment

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Interventions

Dosage Forms; Clindamycin

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Gintaras Juodzbalys, DDS,PhD

  Lithuanian University of Health Sciences

  STUDY CHAIR

• Hom-Lay Wang, DDS,MSD,PhD

  University of Michigan

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, Oral Surgeon, PhD Student

Study Record Dates

• First Submitted: February 2, 2014
• First Posted: February 4, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 2, 2016

Record last verified: 2016-03

Locations

LI (1)