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Study to Evaluate Bone and Gum Dimension Changes Around Dental Implants Placed in Different Positions in Bone.

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ClinicalTrials.gov Identifier: NCT01759537
Recruitment Status : Active, not recruiting
First Posted : January 3, 2013
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dentsply International

Brief Summary:
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 or disease Intervention/treatment Phase
Mouth, Edentulous Device: Ankylos dental endosseous implants-sub-crestal Device: Ankylos dental endosseous implants-Epi-crestal Not Applicable

Detailed Description:
The purpose of this study is to test epicrestal and subcrestal placement of dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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.
Study Start Date : September 2012
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: Implants placed at sub-crestal position.
Ankylos dental endosseous implants-sub-crestal
Device: Ankylos dental endosseous implants-sub-crestal
Implants placed subcrestally
Active Comparator: Epi-crestal implants.
Ankylos dental endosseous implants-Epi-crestal
Device: Ankylos dental endosseous implants-Epi-crestal
Implants placed Epi-crestally



Primary Outcome Measures :
  1. Changes in mid-facial bone levels. [ Time Frame: 18 months, 30 months and 66 months after implant placement. ]
    Changes in mid-facial bone levels to be measured by CAT scan.


Secondary Outcome Measures :
  1. Changes of interproximal levels after loading. [ Time Frame: 18 months, 30 months and 66 months after implant placement. ]
    Measured by periapical radiographs.

  2. Changes in buccal soft tissue level. [ Time Frame: 18 months, 30 months and 66 months after implant placement. ]
    Measured by CAT scan and clinically from a fixed reference point to the mid buccal soft tissue level using a stent.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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).

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): 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 Froum, DDS Bluestone Center for Clinical Research

Additional Information:
Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT01759537     History of Changes
Other Study ID Numbers: Ankylos-Bluestone
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

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