Compare Sterilized Clean vs Sterilized Aseptic Dental Implant Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Instituto de Implantologia
Sponsor:
Information provided by (Responsible Party):
Andre Chen, Instituto de Implantologia
ClinicalTrials.gov Identifier:
NCT01970826
First received: October 19, 2013
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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 ?


Condition Intervention
Endosseous Dental Implant Failure
Bone Loss
Procedure: Single Dental Implants
Procedure: Sterilized Aseptic
Procedure: Sterilized Clean
Procedure: Full-Mouth Dental Implants
Procedure: Partial Rehabilitation
Procedure: Duration of Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sterilized Aseptic Versus Sterilized Clean Field for Dental Implant Placement - Randomized Clinical Control Trial for Non-inferiority Comparison

Resource links provided by NLM:


Further study details as provided by Instituto de Implantologia:

Primary Outcome Measures:
  • Post-Operatory Complications [ Time Frame: From Implant Placement (Baseline) to 4 weeks after (T1) ] [ Designated as safety issue: Yes ]
    Measure the amount of adverse effects in both groups (aseptic vs clean) that happen between time frame baseline to 4 weeks.

  • Osseointegration [ Time Frame: At 8 weeks (T2) after Baseline ] [ Designated as safety issue: Yes ]
    Measure the ability of dental implants to integrate into bone in both groups (aseptic vs clean)


Secondary Outcome Measures:
  • Marginal bone loss [ Time Frame: At Final Restoration placement - Expected Average of 12 Weeks after baseline ] [ Designated as safety issue: No ]
    measure the amount of marginal bone loss at the time of final restoration placement

  • Patient Satisfaction [ Time Frame: At 2 weeks ] [ Designated as safety issue: No ]
    measure the amount of post-operatory discomfort of the patient


Estimated Enrollment: 80
Study Start Date: January 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sterilized Clean Full-Mouth

The operatory room will be prepared with clean instruments but with no aseptic preparation.

Full-mouth dental implants placement will be made, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies.

There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or product.

It will be evaluated the duration of surgery.

Procedure: Sterilized Clean
Operatory room will be prepared clean but not aseptic
Other Name: Clean operatory room
Procedure: Full-Mouth Dental Implants
dental implants for full-mouth implant rehabilitation.
Other Names:
  • Full-mouth rehabilitation
  • Full mouth implant supported 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.
Other Name: Time for implant placement
Active Comparator: Sterilized Aseptic Full-Mouth

The operatory room will be prepared with sterilized aseptic clean instruments. Full-mouth dental implants placement will be performed and involves meticulous hand washing, use of a sterile field, use of sterile gloves for application of a sterile dressing, and use of sterile instruments and fluid only. Involves the use of only sterile instruments and materials in dressing.

There is no contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or products.

It will be evaluated the duration of surgery.

Procedure: Sterilized Aseptic
Operatory room will be prepared totally aseptic
Other Name: aseptic operatory room
Procedure: Full-Mouth Dental Implants
dental implants for full-mouth implant rehabilitation.
Other Names:
  • Full-mouth rehabilitation
  • Full mouth implant supported 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.
Other Name: Time for implant placement
Experimental: Sterilized Clean Single

The operatory room will be prepared with clean instruments but with no aseptic preparation.

Single dental implants placement will be made, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies.

There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or products.

It will be evaluated the duration of surgery.

Procedure: Single Dental Implants
place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.
Other Name: Dental Fixtures
Procedure: Sterilized Clean
Operatory room will be prepared clean but not aseptic
Other Name: Clean operatory room
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.
Other Name: Time for implant placement
Active Comparator: Sterilized Aseptic Single

The operatory room will be prepared with clean instruments but with no aseptic preparation.

Single dental implants placement will be made, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies.

There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or product.

It will be evaluated the duration of surgery.

Procedure: Single Dental Implants
place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.
Other Name: Dental Fixtures
Procedure: Sterilized Aseptic
Operatory room will be prepared totally aseptic
Other Name: aseptic operatory room
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.
Other Name: Time for implant placement
Experimental: Sterilized Clean - Partial

The operatory room will be prepared with clean instruments but with no aseptic preparation.

One or more dental implants will be made for partial rehabilitation, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies.

There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or product.

It will be evaluated the duration of surgery.

Procedure: Sterilized Clean
Operatory room will be prepared clean but not aseptic
Other Name: Clean operatory room
Procedure: Partial Rehabilitation
two or more implants to support partial rehabilitation
Other Name: partial implant-supported 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.
Other Name: Time for implant placement
Active Comparator: Sterilized Aseptic - Partial

The operatory room will be prepared with clean instruments but with no aseptic preparation.

One or more dental implants will be made for partial rehabilitation, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies.

There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or product.

It will be evaluated the duration of surgery.

Procedure: Sterilized Aseptic
Operatory room will be prepared totally aseptic
Other Name: aseptic operatory room
Procedure: Partial Rehabilitation
two or more implants to support partial rehabilitation
Other Name: partial implant-supported 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.
Other Name: Time for implant placement

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All surgeries schedule for implant placement

Exclusion Criteria:

  • Surgeries not made with local anesthesia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970826

Contacts
Contact: André Chen, Msc 00351919774343 tsouchen@gmail.com

Locations
Portugal
University of Lisbon, School of Dentistry Not yet recruiting
Lisbon, Portugal, 1600
Contact: joana velez       joana.velez@institutodeimplantologia.com   
Principal Investigator: Andre Chen, Msc         
Principal Investigator: João Caramês, Phd         
Principal Investigator: João Canta, Msc         
Principal Investigator: Helena Francisco, Msc         
Sponsors and Collaborators
Instituto de Implantologia
Investigators
Principal Investigator: Andre Chen, Msc University of Lisbon, College of Dentistry
Study Director: João Caramês, Phd University of Lisbon, College of Dentistry
Study Chair: João Canta, Msc University of Lisbon, School of Dentistry
Study Chair: Helena Francisco, Msc University of Lisbon, College of Dentistry
  More Information

No publications provided

Responsible Party: Andre Chen, Msc, Instituto de Implantologia
ClinicalTrials.gov Identifier: NCT01970826     History of Changes
Other Study ID Numbers: II-05
Study First Received: October 19, 2013
Last Updated: October 22, 2013
Health Authority: Portugal: Health Ethic Committee

Keywords provided by Instituto de Implantologia:
aseptic sterilized field
clean sterilized field
dental implants
Surgery

ClinicalTrials.gov processed this record on August 26, 2014