NCT01970826

Compare Sterilized Clean vs Sterilized Aseptic Dental Implant Surgery

Sterilized Aseptic Versus Sterilized Clean Field for Dental Implant Placement - Randomized Clinical Control Trial for Non-inferiority Comparison

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Implantology Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In patients that require dental implants , does performing the surgery in clean sterile field compared to aseptic field, produces more post-operatory complications, implant morbidity or patient discomfort ?

Detailed description

The investigators intend to compare two types of operatory room preparation (aseptic versus clean), used world wide, for placing dental implants. The investigators want to see if it has impact on post-operatory healing, osseointegration and success rate of dental implants. Before Study begins the investigators will perform inter-observer agreement in surgical preparation of the surgical suite, implant placements and operatory-room behavior.

Conditions

• Endosseous Dental Implant Failure
• Bone Loss

Interventions

Type	Name	Description
PROCEDURE	Single Dental Implants	place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.
PROCEDURE	Sterilized Aseptic	Operatory room will be prepared totally aseptic
PROCEDURE	Sterilized Clean	Operatory room will be prepared clean but not aseptic
PROCEDURE	Full-Mouth Dental Implants	dental implants for full-mouth implant rehabilitation.
PROCEDURE	Partial Rehabilitation	two or more implants to support partial rehabilitation
PROCEDURE	Duration of Surgery	it will be measure the amount of time to perform the dental implant surgery. It will be measured from the time that the surgeon does the first incision until the last suture is made.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-01-01
• Completion: 2015-06-01
• First posted: 2013-10-28
• Last updated: 2013-10-28

Locations

1 site across 1 country: Portugal