Dental Implant Study to Evaluate Bone and Gum Dimension Changes Around Implants Placed in Different Position Into the Bone.
This study is currently recruiting participants.
Verified January 2013 by Dentsply International
Sponsor:
Dentsply International
Information provided by (Responsible Party):
Dentsply International
ClinicalTrials.gov Identifier:
NCT01759537
First received: December 31, 2012
Last updated: January 2, 2013
Last verified: January 2013
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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:
- Subjects must have read, understood and signed an informed consent form;
- Subjects must be 18 to 70 years of age;
- Subjects must be able and willing to follow study procedures and instructions;
- 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) ;
- Sufficient width and height of bone to place at least 8mm length and any compatible in diameter Ankylos implant;
- Sufficient vertical clearance to place a single tooth crown replacement;
- No apical disorder/inflammation at the area of the implant site.
Exclusion Criteria:
- 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;
- Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study;
- Subjects with parafunctional habits;
- Subjects who have failed to maintain good plaque control;
- 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;
- Absence of occlusal stability in centric occlusion;
- Subjects with the presence of acute infectious lesions in the areas intended for surgery;
- 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)
- Present alcohol or drug abuse;
- Angulation requirements of the restoration exceeding approximately 15 degrees;
- Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration (e.g. calcium channel blocker, dilantin).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759537
Locations
| United States, New York | |
| Bluestone Center for Clinical Research | Recruiting |
| New York, New York, United States, 10010-4086 | |
| Contact: Ismael Khouly, Dr. 212-998-9453 bluestoneimplants@gmail.com | |
| Principal Investigator: Stuart J Froum, DDS | |
Sponsors and Collaborators
Dentsply International
Investigators
| Principal Investigator: | Stuart J Frooum, DDS | Bluestone Center for Clinical Research |
More Information
Additional Information:
Related Info 
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: | January 2, 2013 |
| 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 May 22, 2013