Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses

Edentulism Clinical Trial

Official title:

Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in the Anterior Part of the Mandible and Restored With Fixed Prostheses: a Randomized, Split-mouth, Masked, Prospective, Open, Comparison, Monocenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780273
• Other study ID #: DF 245
• 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

• Edentulism

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