Compare Sterilized Clean vs Sterilized Aseptic Dental Implant Surgery

Implantology Institute

Status: Unknown

Conditions: Endosseous Dental Implant Failure; Bone Loss

Treatments: Procedure: Duration of Surgery; Procedure: Partial Rehabilitation; Procedure: Sterilized Aseptic; Procedure: Single Dental Implants; Procedure: Sterilized Clean; Procedure: Full-Mouth Dental Implants

Study type: Interventional

Funder types: Other

Identifiers

NCT01970826

II-05

Details and patient eligibility

About

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 ?

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All surgeries schedule for implant placement

Exclusion criteria

• Surgeries not made with local anesthesia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 6 patient groups

Sterilized Clean Full-Mouth

Experimental group

Description:

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.

Treatment:

Procedure: Full-Mouth Dental Implants

Procedure: Sterilized Clean

Procedure: Duration of Surgery

Sterilized Aseptic Full-Mouth

Active Comparator group

Description:

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.

Treatment:

Procedure: Full-Mouth Dental Implants

Procedure: Duration of Surgery

Procedure: Sterilized Aseptic

Sterilized Clean Single

Experimental group

Description:

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.

Treatment:

Procedure: Sterilized Clean

Procedure: Single Dental Implants

Procedure: Duration of Surgery

Sterilized Aseptic Single

Active Comparator group

Description:

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.

Treatment:

Procedure: Single Dental Implants

Procedure: Duration of Surgery

Procedure: Sterilized Aseptic

Sterilized Clean - Partial

Experimental group

Description:

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.

Treatment:

Procedure: Sterilized Clean

Procedure: Duration of Surgery

Procedure: Partial Rehabilitation

Sterilized Aseptic - Partial

Active Comparator group

Description:

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.

Treatment:

Procedure: Duration of Surgery

Procedure: Partial Rehabilitation

Procedure: Sterilized Aseptic