Overview

This trial is active, not recruiting.

Condition mouth, edentulous
Treatments ankylos dental endosseous implants-sub-crestal, ankylos dental endosseous implants-epi-crestal
Sponsor Dentsply International
Start date September 2012
End date September 2017
Trial size 48 participants
Trial identifier NCT01759537, Ankylos-Bluestone

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Ankylos dental endosseous implants-sub-crestal
ankylos dental endosseous implants-sub-crestal
Implants placed subcrestally
(Active Comparator)
Ankylos dental endosseous implants-Epi-crestal
ankylos dental endosseous implants-epi-crestal
Implants placed Epi-crestally

Primary Outcomes

Measure
Changes in mid-facial bone levels.
time frame: 18 months and 30 months after implant placement.

Secondary Outcomes

Measure
Changes of interproximal levels after loading.
time frame: 18 months and 30 months after implant placement.
Changes in buccal soft tissue level.
time frame: 18 months and 30 months after implant placement.

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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).

Additional Information

Official title Evaluation of Changes of Hard and Soft Tissues After Epi-crestal and Sub-crestal Placement of Ankylos Dental Implants.
Principal investigator Stuart J Frooum, DDS
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Dentsply International.