Compare Sterilized Clean vs Sterilized Aseptic Dental Implant Surgery
NCT ID: NCT01970826
Last Updated: 2013-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
80 participants
INTERVENTIONAL
2014-01-31
2015-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Sterilized Clean
Operatory room will be prepared clean but not aseptic
Full-Mouth Dental Implants
dental implants for full-mouth implant rehabilitation.
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.
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.
Sterilized Aseptic
Operatory room will be prepared totally aseptic
Full-Mouth Dental Implants
dental implants for full-mouth implant rehabilitation.
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.
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.
Single Dental Implants
place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.
Sterilized Clean
Operatory room will be prepared clean but not aseptic
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.
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.
Single Dental Implants
place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.
Sterilized Aseptic
Operatory room will be prepared totally aseptic
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.
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.
Sterilized Clean
Operatory room will be prepared clean but not aseptic
Partial Rehabilitation
two or more implants to support partial rehabilitation
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.
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.
Sterilized Aseptic
Operatory room will be prepared totally aseptic
Partial Rehabilitation
two or more implants to support partial rehabilitation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Single Dental Implants
place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.
Sterilized Aseptic
Operatory room will be prepared totally aseptic
Sterilized Clean
Operatory room will be prepared clean but not aseptic
Full-Mouth Dental Implants
dental implants for full-mouth implant rehabilitation.
Partial Rehabilitation
two or more implants to support partial rehabilitation
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Implantology Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Andre Chen
Msc
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andre Chen, Msc
Role: PRINCIPAL_INVESTIGATOR
University of Lisbon, College of Dentistry
João Caramês, Phd
Role: STUDY_DIRECTOR
University of Lisbon, College of Dentistry
João Canta, Msc
Role: STUDY_CHAIR
University of Lisbon, School of Dentistry
Helena Francisco, Msc
Role: STUDY_CHAIR
University of Lisbon, College of Dentistry
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Lisbon, School of Dentistry
Lisbon, Lisbon District, Portugal
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
joana velez
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
II-05
Identifier Type: -
Identifier Source: org_study_id