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

Edentulism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807456
• Other study ID #: YA-PRO-0001
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: December 2013

Study information

• Verified date: November 2022
• Source: Dentsply Sirona Implants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Edentulism

Intervention

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

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Praxis Dr Robert Nölken	Lindau
Italy	Studio Dentistico Donati	Perugia
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants

Countries where clinical trial is conducted

United States,  Germany,  Italy, 

References & 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. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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