- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02546713
Abutment Macro Design and Peri-implant Tissues
The Influence of Abutment Macro-design on Peri-implant Tissue Dimensions for Guided Placed and Restored Implants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Implant placement and abutment design will be planned with a computer software for guided implant treatment (SIMPLANT). The surgical implant placement will be performed under manufacturer's protocol by placing the implant platform 1mm below the buccal aspect of the osteotomy (Koutouzis et al 2013). Virtually designed, permanent CAD-CAM fabricated abutments (ATLANTIS, DENTSPLY) with different configuration of the subcritical contour (emergence shape) will be connected to the implants and temporary crowns will be delivered.
Implants of the Group 1 will have permanent abutments with a concave configuration of the subcritical contour (emergence shape).
Implants of the Group 2 will have permanent abutments with a convex configuration of the subcritical contour (emergence shape).
The patients will be restored with single crowns 3 months following implant installation.
A randomization protocol will be produced from a computer-generated list for the distribution of subjects in the two treatment groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Fort Lauderdale, Florida, United States, 33328
- Nova Southeastern University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
General Inclusion criteria:
- - Age more than 21 years
- Absence of relevant medical conditions
- Availability for 12 month follow-up
Specific Inclusion criteria:
- One missing tooth in the maxillary premolar region
- Presence of two adjacent teeth at the implant site
- Absence of periodontal disease
- Healed osseous architecture enough to receive an implant with a diameter of at least 3.5 mm and a sufficient amount of bone for placing implants with a length of at least 9 mm
General Exclusion Criteria:
- - Pregnancy at the screening visit.
- Smoking more than 10 cig/day
Specific Exclusion criteria:
- Adjacent implants
- Presence of periapical radiolucency at the adjacent teeth
- Missing adjacent teeth
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Group 1
Abutments with a concave configuration of the subcritical contour (emergence shape).
|
Implants will be restored with abutments with concave configuration of the subcritical contour
|
Other: Group 2
Abutments with convex configuration of the subcritical contour (emergence shape)
|
Implants will be restored with abutments with convex configuration of the subcritical contour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peri-implant mucosa margin position change
Time Frame: Day 7-10 to the Day 360
|
The primary outcome variable will be change on peri-implant mucosa margin position.
|
Day 7-10 to the Day 360
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Theofilos Koutouzis, DDS, Nova Southeastern University
Publications and helpful links
General Publications
- Koutouzis T, Neiva R, Nair M, Nonhoff J, Lundgren T. Cone beam computed tomographic evaluation of implants with platform-switched Morse taper connection with the implant-abutment interface at different levels in relation to the alveolar crest. Int J Oral Maxillofac Implants. 2014 Sep-Oct;29(5):1157-63. doi: 10.11607/jomi.3411.
- Koutouzis T, Koutouzis G, Tomasi C, Lundgren T. Immediate loading of implants placed with the osteotome technique: one-year prospective case series. J Periodontol. 2011 Nov;82(11):1556-62. doi: 10.1902/jop.2011.100751. Epub 2011 May 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- I-AA-14-075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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