Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Open, Single Arm, Multi-center Study to Evaluate Maintenance of Lingual Bone in Healed Ridges With the ASTRA TECH Implant System, OsseoSpeed™ Profile Implant. A 3-year Follow-up Study

Conditions
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Edentulism

Intervention / Treatment
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* Device: ASTRA TECH Implant System, OsseoSpeed™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent Aged 18-75 years at enrolment A lingual-buccal difference in bone height between 2.0-5.0 mm at the implant site History of edentulism in the study area of at least 3 months Presence of alveolar bone crest dimensions judged by the investigator to allow ≥1mm of bone circumferential to the implant after implant placement. In need for a single implant replacing a missing tooth in any location with an adjacent natural tooth mesially, and an adjacent natural tooth or edentulous space distally to the planned implant position (i.e. no existing or planned implant adjacent to the planned study implant position) Deemed by the investigator as likely to present an initially stable implant situation Exclusion Criteria: Uncontrolled pathological processes in the oral cavity Known or suspected current malignancy History of radiation therapy in the head and neck region History of chemotherapy within 5 years prior to surgery Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration Uncontrolled diabetes mellitus Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration Smoking more than 10 cigarettes per day Present alcohol and/or drug abuse Current need for bone grafting in the planned implant area Previous enrolment in the present study Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months Involvement in the planning and conduct of the study (applies to both Sponsor staff or staff at the study site) Unlikely to be able to comply with study procedures, as judged by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects treated with ASTRA TECH Implant System, OsseoSpeed™ Profile implant<br> | Device: ASTRA TECH Implant System, OsseoSpeed™<br>* ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Baseline and 12 months, 24 months, and 36 months post implant placement |