The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is sloped in a lingual to buccal direction. The hypothesis is that the sloped marginal contour of the implant will help preserve the lingual/palatinal marginal bone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
Department of Periodontology, College of Dental Medicine, Nova Southeastern University
Fort Lauderdale, Florida, United States
Department of Periodontics, Robert Schattner Center, School of Dental Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medizinische Hochschule Hannover
Hanover, Germany
Praxis Dr Robert Nölken
Lindau, Germany
Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement
Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant, i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.
Time frame: At baseline and 16 weeks
Implant Survival Rate
The survival rate for individual implants was evaluated at each visit. Any removed implant was considered an implant loss, regardless of reason for removal.
Time frame: 21 weeks, 12 months, 24 months and 36 months post implant placement.
Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level
MBL alteration assessed by measuring the distance from the implant reference point to the most conical bone-to-implant contact on the mesial and distal side of the implant. The mean of all values for one subject was calculated and used for analysis.
Time frame: Baseline and 16 weeks, 21 weeks, 12 months, and 36 months post implant placement
Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)
BoP was assessed by recording bleeding after probing at the mesial, distal, buccal, and palatal surfaces of the implant site.
Time frame: 21 weeks, 12 months, 24 months, and 36 months post implant placement
Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
PPD was measured using a regular peridontal probe from the gingival margin to nearest whole millimeter. The average PPD change from permanent restoration is presented on implant level.
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Studio Dentistico Donati
Perugia, Italy
Time frame: Baseline and 12 months, 24 months, and 36 months post implant placement
Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration
CAL was measure with a probe from the crown margin (the interface between the abutment) to the crown at the mesial, buccal, distal, and lingual aspects of the implant. The average CAL change from permanent restoration is presented on implant level.
Time frame: Baseline and 12 months, 24 months, and 36 months post implant placement