Compare Sterilized Clean vs Sterilized Aseptic Dental Implant Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endosseous Dental Implant Failure, Bone Loss

Intervention / Treatment
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* Procedure: Single Dental Implants
* Procedure: Sterilized Aseptic
* Procedure: Sterilized Clean
* Procedure: Full-Mouth Dental Implants
* Procedure: Partial Rehabilitation
* Procedure: Duration of Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All surgeries schedule for implant placement Exclusion Criteria: Surgeries not made with local anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sterilized Clean Full-Mouth<br>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<br>* Operatory room will be prepared clean but not aseptic<br>* Other names: Clean operatory room;Procedure: Full-Mouth Dental Implants<br>* dental implants for full-mouth implant rehabilitation.<br>* Other names: Full mouth implant supported rehabilitation;Procedure: Duration of Surgery<br>* 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.<br>* Other names: Time for implant placement;|
| Active Comparator: Sterilized Aseptic Full-Mouth<br>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<br>* Operatory room will be prepared totally aseptic<br>* Other names: aseptic operatory room;Procedure: Full-Mouth Dental Implants<br>* dental implants for full-mouth implant rehabilitation.<br>* Other names: Full mouth implant supported rehabilitation;Procedure: Duration of Surgery<br>* 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.<br>* Other names: Time for implant placement;|
| Experimental: Sterilized Clean Single<br>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<br>* place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.<br>* Other names: Dental Fixtures;Procedure: Sterilized Clean<br>* Operatory room will be prepared clean but not aseptic<br>* Other names: Clean operatory room;Procedure: Duration of Surgery<br>* 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.<br>* Other names: Time for implant placement;|
| Active Comparator: Sterilized Aseptic Single<br>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<br>* place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.<br>* Other names: Dental Fixtures;Procedure: Sterilized Aseptic<br>* Operatory room will be prepared totally aseptic<br>* Other names: aseptic operatory room;Procedure: Duration of Surgery<br>* 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.<br>* Other names: Time for implant placement;|
| Experimental: Sterilized Clean - Partial<br>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<br>* Operatory room will be prepared clean but not aseptic<br>* Other names: Clean operatory room;Procedure: Partial Rehabilitation<br>* two or more implants to support partial rehabilitation<br>* Other names: partial implant-supported rehabilitation;Procedure: Duration of Surgery<br>* 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.<br>* Other names: Time for implant placement;|
| Active Comparator: Sterilized Aseptic - Partial<br>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<br>* Operatory room will be prepared totally aseptic<br>* Other names: aseptic operatory room;Procedure: Partial Rehabilitation<br>* two or more implants to support partial rehabilitation<br>* Other names: partial implant-supported rehabilitation;Procedure: Duration of Surgery<br>* 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.<br>* Other names: Time for implant placement;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aseptic sterilized field, clean sterilized field, dental implants, Surgery