Compare Sterilized Clean vs Sterilized Aseptic Dental Implant Surgery

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01970826
• Other study ID #: II-05
• Status: Not yet recruiting
• Phase: N/A
• First received: October 19, 2013
• Last updated: October 22, 2013
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2013
• Source: Instituto de Implantologia
• Contact: André Chen, Msc
• Phone: 00351919774343
• Email: tsouchen[@]gmail.com
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Interventional

Clinical Trial 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 ?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All surgeries schedule for implant placement

Exclusion Criteria:

• Surgeries not made with local anesthesia

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Loss
• Endosseous Dental Implant Failure

Intervention

Procedure:
• Single Dental Implants
place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.
• Sterilized Aseptic
Operatory room will be prepared totally aseptic
• Sterilized Clean
Operatory room will be prepared clean but not aseptic
• Full-Mouth Dental Implants
dental implants for full-mouth implant rehabilitation.
• Partial Rehabilitation
two or more implants to support partial rehabilitation
• 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.

Locations

Country	Name	City	State
Portugal	University of Lisbon, School of Dentistry	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Implantologia

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Operatory Complications	Measure the amount of adverse effects in both groups (aseptic vs clean) that happen between time frame baseline to 4 weeks.	From Implant Placement (Baseline) to 4 weeks after (T1)	Yes
Primary	Osseointegration	Measure the ability of dental implants to integrate into bone in both groups (aseptic vs clean)	At 8 weeks (T2) after Baseline	Yes
Secondary	Marginal bone loss	measure the amount of marginal bone loss at the time of final restoration placement	At Final Restoration placement - Expected Average of 12 Weeks after baseline	No
Secondary	Patient Satisfaction	measure the amount of post-operatory discomfort of the patient	At 2 weeks	No