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

NCT00807456 | Completed Results

• 1 other identifier: YA-PRO-0001
• Study Type: interventional
• Target: 65
• Locations: 3 countries
• Sites: 5

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.

Conditions

Edentulism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Implant Survival Rate

  21 weeks, 12 months, 24 months and 36 months post implant placement.

• 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

• Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)

  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

  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

  Baseline and 12 months, 24 months, and 36 months post implant placement

Study Arms (1)

Subjects treated with ASTRA TECH Implant System, OsseoSpeed™ Profile implant

EXPERIMENTAL

Device: ASTRA TECH Implant System, OsseoSpeed™

Interventions

ASTRA TECH Implant System, OsseoSpeed™ DEVICE

ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.

Subjects treated with ASTRA TECH Implant System, OsseoSpeed™ Profile implant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (5)

Department of Periodontology, College of Dental Medicine, Nova Southeastern University

Fort Lauderdale, Florida, 33328-2018, United States

Location

Department of Periodontics, Robert Schattner Center, School of Dental Medicine, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Praxis Dr Robert Nölken

Lindau, D-88131, Germany

Location

Studio Dentistico Donati

Perugia, IT-06121, Italy

Location

Related Publications (1)

• 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.

  PMID: 23210667 RESULT

Results Point of Contact

• Title: Manager Global Clinical Affairs
• Organization: DENTSPLY Implants

ClinicalResearchMolndal@dentsplysirona.com

+46313763500

Study Officials

• Tord Berglundh, Prof.

  Department of Periodontology, Sahlgrenska Academy at University of Gothenburg

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 12, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 17, 2022
• Results First Posted: May 30, 2016

Record last verified: 2022-11

Locations

IT (1); US (2); DE (2)