Clinical trial NCT00807456: Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulism
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2008-12-12
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement
timeFrame: At baseline and 16 weeks
Secondary outcomes:
measure: Implant Survival Rate
timeFrame: 21 weeks, 12 months, 24 months and 36 months post implant placement.
measure: Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level
timeFrame: Baseline and 16 weeks, 21 weeks, 12 months, and 36 months post implant placement
measure: Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)
timeFrame: 21 weeks, 12 months, 24 months, and 36 months post implant placement
measure: Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
timeFrame: Baseline and 12 months, 24 months, and 36 months post implant placement
measure: Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration
timeFrame: Baseline and 12 months, 24 months, and 36 months post implant placement
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Department of Periodontology, College of Dental Medicine, Nova Southeastern University
state: Florida
city: Philadelphia
country: United States
facility: Department of Periodontics, Robert Schattner Center, School of Dental Medicine, University of Pennsylvania
state: Pennsylvania
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Lindau
country: Germany
facility: Praxis Dr Robert Nölken
city: Perugia
country: Italy
facility: Studio Dentistico Donati
Study officials:
affiliation: Department of Periodontology, Sahlgrenska Academy at University of Gothenburg
name: Tord Berglundh, Prof.
role: STUDY_CHAIR
References:
citation: Noelken R, Donati M, Fiorellini J, Gellrich NC, Parker W, Wada K, Berglundh T. Soft and hard tissue alterations around implants placed in an alveolar ridge with a sloped configuration. Clin Oral Implants Res. 2014 Jan;25(1):3-9. doi: 10.1111/clr.12079. Epub 2012 Dec 5.