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

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 ?

Study Overview

• Status: Unknown
• Conditions: Bone Loss; Endosseous Dental Implant Failure
• Intervention / Treatment: Procedure: Sterilized Clean; Procedure: Full-Mouth Dental Implants; Procedure: Duration of Surgery; Procedure: Sterilized Aseptic; Procedure: Single Dental Implants; Procedure: Partial Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal, 1600
    • University of Lisbon, School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All surgeries schedule for implant placement

Exclusion Criteria:

• Surgeries not made with local anesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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: 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 Names: Time for implant placement; Procedure: Sterilized Aseptic; Operatory room will be prepared totally aseptic; Other Names: aseptic operatory room
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: Sterilized Clean; Operatory room will be prepared clean but not aseptic; Other Names: 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 Names: Time for implant placement; Procedure: Single Dental Implants; place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.; Other Names: Dental Fixtures
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: 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 Names: Time for implant placement; Procedure: Sterilized Aseptic; Operatory room will be prepared totally aseptic; Other Names: aseptic operatory room; Procedure: Single Dental Implants; place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.; Other Names: Dental Fixtures
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 Names: 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 Names: Time for implant placement; Procedure: Partial Rehabilitation; two or more implants to support partial rehabilitation; Other Names: partial implant-supported rehabilitation
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: 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 Names: Time for implant placement; Procedure: Sterilized Aseptic; Operatory room will be prepared totally aseptic; Other Names: aseptic operatory room; Procedure: Partial Rehabilitation; two or more implants to support partial rehabilitation; Other Names: partial implant-supported rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Osseointegration	Measure the ability of dental implants to integrate into bone in both groups (aseptic vs clean)	At 8 weeks (T2) after Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient Satisfaction	measure the amount of post-operatory discomfort of the patient	At 2 weeks

Collaborators and Investigators

• Sponsor: Implantology Institute
• 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

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: October 19, 2013
• First Submitted That Met QC Criteria: October 22, 2013
• First Posted (Estimate): October 28, 2013

Study Record Updates

• Last Update Posted (Estimate): October 28, 2013
• Last Update Submitted That Met QC Criteria: October 22, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Surgery; dental implants; aseptic sterilized field; clean sterilized field
• Other Study ID Numbers: II-05