N/A
N=65
Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone
Edentulism
Bottom Line
View on ClinicalTrials.gov: NCT00807456 ↗Enrolled (actual)
65
Serious AEs
3.1%
Results posted
May 2016
Primary outcome: Primary: Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement — -0.02 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ASTRA TECH Implant System, OsseoSpeed™ (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dentsply Sirona Implants and Consumables
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement |
-0.02 | — |
| SECONDARY Implant Survival Rate |
65; 64; 59; 57 | — |
| SECONDARY Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level |
-0.28; -0.48; -0.29; -0.57 | — |
| SECONDARY Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP) |
2; 20; 16; 21 | — |
| SECONDARY Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration |
0.28; 0.31; 0.36 | — |
| SECONDARY Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration |
0.02; 0.14; 0.11 | — |
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
Data sourced from ClinicalTrials.gov (NCT00807456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.