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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 ?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sterilized Clean Full-Mouth | Experimental | 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. |
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| Sterilized Aseptic Full-Mouth | Active Comparator | 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. |
|
| Sterilized Clean Single | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Dental Implants | Procedure | place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| André Chen, Msc | Contact | 00351919774343 | tsouchen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andre Chen, Msc | University of Lisbon, College of Dentistry | Principal Investigator |
| João Caramês, Phd | University of Lisbon, College of Dentistry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lisbon, School of Dentistry | Lisbon | Lisbon District | 1600 | Portugal |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| D013995 | Time |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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| Sterilized Aseptic Single | Active Comparator | 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. |
|
| Sterilized Clean - Partial | Experimental | 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. |
|
| Sterilized Aseptic - Partial | Active Comparator | 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. |
|
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| Sterilized Aseptic | Procedure | Operatory room will be prepared totally aseptic |
|
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| Sterilized Clean | Procedure | Operatory room will be prepared clean but not aseptic |
|
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| Full-Mouth Dental Implants | Procedure | dental implants for full-mouth implant rehabilitation. |
|
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| Partial Rehabilitation | Procedure | two or more implants to support partial rehabilitation |
|
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| Duration of Surgery | Procedure | 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. |
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measure the amount of post-operatory discomfort of the patient
| At 2 weeks |
| João Canta, Msc |
| University of Lisbon, School of Dentistry |
| Study Chair |
| Helena Francisco, Msc | University of Lisbon, College of Dentistry | Study Chair |
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D055585 | Physical Phenomena |