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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00780273
Other study ID # DF 245
Secondary ID
Status Completed
Phase Phase 4
First received October 24, 2008
Last updated August 18, 2014
Start date September 2008
Est. completion date April 2012

Study information

Verified date August 2014
Source Dentsply International
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Change in crestal bone level implants at 5% significance level.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- age 18 to 80

- male or female (female non-pregnant)

- sufficient oral hygiene

- no inflammation/disorder in the area of implant site

- edentulous mandible and sufficient prosthetic and conservative

- sufficient width and height of bone to place implants with diameters of 4.8mm and length of 11 mm

- provide written informed consent

Exclusion Criteria:

- demonstrate a need for pre-surgical bone or soft tissue augmentation in planned implant areas

- exhibit angulation requirements of restoration exceeding 15 degrees

- systemic metabolic disorder that would compromise post-operative tissue regeneration or osseointegration

- taking medication that would compromise post-operative healing and/or osseointegration

- bone disorders such as osteoporosis, hyperparathyroidism, Paget's disease, diabetes mellitus

- oncology treatment

- oral infection

- acute gingivitis and/or periodontitis

- local bone defects in the area of planned implantation

- disorders of oral mucosa (e.g., leukoplakia, oral lichen, pemphigoid lesions)

- received investigational drug within 30 days

- history of illicit drugs or alcohol abuse

- history of addiction to medication

- allergic to dental materials

- nicotine abuse (> 20 cigarettes/day)

- pregnant or nursing

- clinical significant or unstable medical or physiological conditions that would compromise participation in study

- unable or unwilling to return for follow-up visits for a period of 24 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
Ankylos Implants
ANKYLOS Implant System vs Certain PREVAIL Implant
Biomet 3i Prevail Implants


Locations

Country Name City State
United States University of Rochester, Eastman Dept of Dentistry Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
Dentsply International

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants. 6 months after surgery No
Primary Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants. 12 months after surgery No
Primary Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants. 24 months after surgery No
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