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Immediate Implant Placement in the Esthetic Zone

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Hacettepe University
Universidad de Granada
University of Michigan
Information provided by (Responsible Party):
Povilas Daugela, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01533571
First received: February 7, 2012
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  Purpose

This study aims to examine dimensional alveolar ridge alterations and prevent buccal plate resorption and soft tissue recession following immediate implant placement in extraction sockets in the maxillary esthetic zone using different socket morphology-guided treatment modalities.

Expected results of the study are:

  • To have found the optimal materials and GBR procedures modalities for buccal plate resorption degree reduction;
  • Soft tissue recession and best esthetic result achievement. There will be possibilities to study socket morphology influence on final esthetic result achievement.

Condition Intervention
Unspecified Atrophy of Edentulous Alveolar Ridge
 Procedure: Immediate implant placement with simultaneous bone grafting

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immediate Implant Placement After Tooth Extraction in the Esthetic Zone: Extraction Socket Morphology-Guided Treatment Modalities and Esthetic Outcome

Resource links provided by NLM:

MedlinePlus related topics: Bone Grafts
U.S. FDA Resources

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

Primary Outcome Measures:
  • Complex Esthetic Index (CEI) [ Time Frame: One year ] [ Designated as safety issue: No ]
    CEI will be evaluated by two calibrated observers and mean will be calculated. Complex esthetic index is composed of three components: the soft tissue index (S), predictive index (P) and implant supported restoration index (R).


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate implant + xenogenic graft
Treatment with immediate implant and GBR using xenogenic bone graft material
 Procedure: Immediate implant placement with simultaneous bone grafting
  • Flapless surgery is used for surgical implant installation.
  • Implant is placed in the cingulum position of adjacent teeth incisal edge.
  • After placement of optimal implant the remaining gap between the implant and the surrounding bony walls should be at least 2 mm or should be need for GBR of buccal plate outside the socket.
  • Two types of bone graft materials will be applied for two groups of patients: Group I - natural bovine bone grafting material + resorbable natural soft tissue membrane; Group II - processed human allograft + resorbable natural soft tissue membrane .

Crown can be fixed on abutment if there is initial stability under 35 Ncm insertion torque. If insertion torque will be less, crown should be bond to neighboring teeth using composite material.

Other Names:
  • Cerabone
  • Jason membrane
  • Maxgarft
  • Straumann Bone level implant
Active Comparator: Immediate implant + allogenic graft
Treatment with immediate implant and GBR using allogenic bone graft material.
 Procedure: Immediate implant placement with simultaneous bone grafting
  • Flapless surgery is used for surgical implant installation.
  • Implant is placed in the cingulum position of adjacent teeth incisal edge.
  • After placement of optimal implant the remaining gap between the implant and the surrounding bony walls should be at least 2 mm or should be need for GBR of buccal plate outside the socket.
  • Two types of bone graft materials will be applied for two groups of patients: Group I - natural bovine bone grafting material + resorbable natural soft tissue membrane; Group II - processed human allograft + resorbable natural soft tissue membrane .

Crown can be fixed on abutment if there is initial stability under 35 Ncm insertion torque. If insertion torque will be less, crown should be bond to neighboring teeth using composite material.

Other Names:
  • Cerabone
  • Jason membrane
  • Maxgarft
  • Straumann Bone level implant

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • General health satisfactory
  • Single-tooth replacement in the maxillary anterior segments
  • Extraction socket Type I and Type II (Juodzbalys et al.)
  • Non-adjacent implant sites and prosthetic restorations
  • Patient will not wear any kind of removable prosthesis over the treatment area;
  • Availability of complete clinical records.

Exclusion Criteria:

  • Uncontrolled diabetes
  • Immunodeficiency diseases
  • Heavy smokers (more than 10 cigarettes a day)
  • Untreated periodontal disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533571

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Lithuania
Lithuanian University of Health Sciences
Kaunas, Lithuania
Spain
University of Granada
Granada, Spain
Turkey
Hacettepe University
Ankara, Turkey
Sponsors and Collaborators
Lithuanian University of Health Sciences
Hacettepe University
Universidad de Granada
University of Michigan
Investigators
Study Chair: Gintaras Juodzbalys, Professor Lithuanian University of Health Sciences (Lithuania)
Study Chair: Hom-Lay Wang, Professor University of Michigan
Principal Investigator: Pablo Galindo-Moreno, Professor University of Granada (Spain)
Principal Investigator: Tolga F Tozum, Professor Hacettepe University (Turkey)
Principal Investigator: Povilas Daugela, Dr. Lithuanian University of Health Sciences (Lithuania)
Principal Investigator: Algirdas Puisys, Dr. Lithuanian University of Health Sciences (Lithuania)
  More Information

Additional Information:
Journal of Oral & Maxillofacial Research (JOMR)  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Povilas Daugela, Principal Investigator, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT01533571     History of Changes
Other Study ID Numbers: Juodzbalys
Study First Received: February 7, 2012
Last Updated: February 29, 2012
Health Authority: Lithuania: Bioethics Committee

Keywords provided by Lithuanian University of Health Sciences:
Guided Bone Regeneration
Dental Implant
Alveolar Ridge Augmentation
Socket graft

Additional relevant MeSH terms:
Mouth, Edentulous
Atrophy
Mouth Diseases
 Stomatognathic Diseases
Tooth Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013