Dental Implant Study to Evaluate Bone and Gum Dimension Changes Around Implants Placed in Different Position Into the Bone.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dentsply International
ClinicalTrials.gov Identifier:
NCT01759537
First received: December 31, 2012
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to test two standard of care techniques of placing dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.


Condition Intervention
Mouth, Edentulous
Device: Ankylos dental endosseous implants.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Changes of Hard and Soft Tissues After Epi-crestal and Sub-crestal Placement of Ankylos Dental Implants.

Further study details as provided by Dentsply International:

Primary Outcome Measures:
  • Changes in mid-facial bone levels. [ Time Frame: 18 months and 30 months after implant placement. ] [ Designated as safety issue: No ]
    Changes in mid-facial bone levels to be measured by CAT scan.


Secondary Outcome Measures:
  • Changes of interproximal levels after loading. [ Time Frame: 18 months and 30 months after implant placement. ] [ Designated as safety issue: No ]
    Measured by periapical radiographs.

  • Changes in buccal soft tissue level. [ Time Frame: 18 months and 30 months after implant placement. ] [ Designated as safety issue: No ]
    Measured by CAT scan and clinically from a fixed reference point to the mid buccal soft tissue level using a stent.


Estimated Enrollment: 48
Study Start Date: September 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implants placed at sub-crestal position.
Test treatment where Ankylos dental implants are placed 1.5 - 2.0 mm subcrestally.
Device: Ankylos dental endosseous implants.
Active Comparator: Epi-crestal implants.
Control treatment where the Ankylos implant will be placed at epi-crestal position (0.0 mm).
Device: Ankylos dental endosseous implants.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects must have read, understood and signed an informed consent form;
  2. Subjects must be 18 to 70 years of age;
  3. Subjects must be able and willing to follow study procedures and instructions;
  4. Subjects must have indication to receive two implants in a bilateral maxillary or mandibular edentulous areas (for at least 4 months post extraction) in areas of pre-molars (first or second) and molars (firstor second) ;
  5. Sufficient width and height of bone to place at least 8mm length and any compatible in diameter Ankylos implant;
  6. Sufficient vertical clearance to place a single tooth crown replacement;
  7. No apical disorder/inflammation at the area of the implant site.

Exclusion Criteria:

  1. Subjects participating in other clinical studies within 1 month prior to screening and/or involving therapeutic intervention (either medical or dental) that could affect bone or soft tissue healing;
  2. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study;
  3. Subjects with parafunctional habits;
  4. Subjects who have failed to maintain good plaque control;
  5. Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy which would preclude periodontal surgery;
  6. Absence of occlusal stability in centric occlusion;
  7. Subjects with the presence of acute infectious lesions in the areas intended for surgery;
  8. History within the last 3 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per day)
  9. Present alcohol or drug abuse;
  10. Angulation requirements of the restoration exceeding approximately 15 degrees;
  11. Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration (e.g. calcium channel blocker, dilantin).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759537

Locations
United States, New York
Bluestone Center for Clinical Research
New York, New York, United States, 10010-4086
Sponsors and Collaborators
Dentsply International
Investigators
Principal Investigator: Stuart J Frooum, DDS Bluestone Center for Clinical Research
  More Information

Additional Information:
No publications provided

Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT01759537     History of Changes
Other Study ID Numbers: Ankylos-Bluestone
Study First Received: December 31, 2012
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on July 22, 2014