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

Not Applicable

Completed

• Conditions: Edentulism
• Interventions: Device: ASTRA TECH Implant System, OsseoSpeed™

• Registration Number: NCT00807456
• Lead Sponsor: Dentsply Sirona Implants and Consumables

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-11
• Study First Submitted QC: 2008-12-11
• Study First Posted: 2008-12-12
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Results First Submitted: 2016-03-16
• Results First Submitted QC: 2016-04-26
• Results First Posted: 2016-05-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™ Profile implant	ASTRA TECH Implant System, OsseoSpeed™	-

Primary Outcome Measures

Name	Time	Method
Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement	At baseline and 16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration	Baseline and 12 months, 24 months, and 36 months post implant placement	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.
Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level	Baseline and 16 weeks, 21 weeks, 12 months, and 36 months post implant placement	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.
Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)	21 weeks, 12 months, 24 months, and 36 months post implant placement	BoP was assessed by recording bleeding after probing at the mesial, distal, buccal, and palatal surfaces of the implant site.
Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration	Baseline and 12 months, 24 months, and 36 months post implant placement	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.
Implant Survival Rate	21 weeks, 12 months, 24 months and 36 months post implant placement.	The survival rate for individual implants was evaluated at each visit. Any removed implant was considered an implant loss, regardless of reason for removal.

Trial Locations

Locations (5)

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

Praxis Dr Robert Nölken; 🇩🇪 Lindau, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Studio Dentistico Donati; 🇮🇹 Perugia, Italy