Endosseous Dental Implant FailureNCT01970826
Compare Sterilized Clean vs Sterilized Aseptic Dental Implant Surgery
A study testing Single Dental Implants, Sterilized Aseptic and Sterilized Clean in people with Endosseous Dental Implant Failure and Bone Loss, run by Implantology Institute at 1 site in Portugal.
Trial summary
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 ? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endosseous Dental Implant Failure, Bone Loss
- What is being tested?
- Single Dental Implants, Sterilized Aseptic and Sterilized Clean
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All surgeries schedule for implant placement
Who cannot join
- Surgeries not made with local anesthesia
Trial locations and contacts
1 site in 1 country.
Portugal1 site
University of Lisbon, School of Dentistry
Lisbon, Lisbon District, 1600
joana velez, joana.velez@institutodeimplantologia.com
Andre Chen, Msc
About this study
Official title: 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 ?
Read the 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.
- Conditions
- Endosseous Dental Implant Failure, Bone Loss
- Being tested
- Single Dental Implants, Sterilized Aseptic, Sterilized Clean, Full-Mouth Dental Implants, Partial Rehabilitation
- Keywords
- aseptic sterilized field, clean sterilized field, dental implants, Surgery
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Dental ImplantsProcedure or surgery
Also called Dental Fixtures
place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.
Sterilized AsepticProcedure or surgery
Also called aseptic operatory room
Operatory room will be prepared totally aseptic
Sterilized CleanProcedure or surgery
Also called Clean operatory room
Operatory room will be prepared clean but not aseptic
Full-Mouth Dental ImplantsProcedure or surgery
Also called Full-mouth rehabilitation, Full mouth implant supported rehabilitation
dental implants for full-mouth implant rehabilitation.
Partial RehabilitationProcedure or surgery
Also called partial implant-supported rehabilitation
two or more implants to support partial rehabilitation
Duration of SurgeryProcedure or surgery
Also called Time for implant placement
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Sterilized Clean; Procedure: Full-Mouth Dental Implants; Procedure: Duration of Surgery |
| 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. Receives: Procedure: Sterilized Aseptic; Procedure: Full-Mouth Dental Implants; Procedure: 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. Receives: Procedure: Single Dental Implants; Procedure: Sterilized Clean; Procedure: Duration of Surgery |
| 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. Receives: Procedure: Single Dental Implants; Procedure: Sterilized Aseptic; Procedure: 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. Receives: Procedure: Sterilized Clean; Procedure: Partial Rehabilitation; Procedure: 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. Receives: Procedure: Sterilized Aseptic; Procedure: Partial Rehabilitation; Procedure: Duration of Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operatory Complications
Measure the amount of adverse effects in both groups (aseptic vs clean) that happen between time frame baseline to 4 weeks.
Measured: 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)
Measured: At 8 weeks (T2) after Baseline
Secondary outcomes (2)
Marginal bone loss
measure the amount of marginal bone loss at the time of final restoration placement
Measured: At Final Restoration placement - Expected Average of 12 Weeks after baseline
Patient Satisfaction
measure the amount of post-operatory discomfort of the patient
Measured: At 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endosseous Dental Implant FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Chen, Implantology Institute
- Investigators
- Andre Chen, Msc, Principal investigator, University of Lisbon, College of DentistryJoão Caramês, Phd, Study director, University of Lisbon, College of DentistryJoão Canta, Msc, Study chair, University of Lisbon, School of DentistryHelena Francisco, Msc, Study chair, University of Lisbon, College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970826
- Sponsor's protocol ID
- II-05
- Status last verified
- Oct 2013
- First submitted
- 19 Oct 2013
- Last updated
- 28 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sterilized Aseptic Versus Sterilized Clean Field for Dental Implant Placement - Randomized Clinical Control Trial for Non-inferiority Comparison
- ClinicalTrials.gov ID
- NCT01970826
- Acronym / sponsor ID
- II-05
- Conditions
- Endosseous Dental Implant Failure, Bone Loss
- Keywords
- aseptic sterilized field, clean sterilized field, dental implants, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sterilized Clean Full-Mouth | Experimental | Procedure: Sterilized Clean, Procedure: Full-Mouth Dental Implants, Procedure: Duration of SurgeryThe 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 Aseptic Full-Mouth | Active comparator | Procedure: Sterilized Aseptic, Procedure: Full-Mouth Dental Implants, Procedure: Duration of SurgeryThe 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 | Procedure: Single Dental Implants, Procedure: Sterilized Clean, Procedure: Duration of SurgeryThe 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. |
| Sterilized Aseptic Single | Active comparator | Procedure: Single Dental Implants, Procedure: Sterilized Aseptic, Procedure: Duration of SurgeryThe 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 | Procedure: Sterilized Clean, Procedure: Partial Rehabilitation, Procedure: Duration of SurgeryThe 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 | Procedure: Sterilized Aseptic, Procedure: Partial Rehabilitation, Procedure: Duration of SurgeryThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All surgeries schedule for implant placement
Key exclusion criteria (1 listed)
- Surgeries not made with local anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Dental ImplantsAlso: Dental Fixturesplace single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines. | Procedure or surgery | Sterilized Aseptic Single, Sterilized Clean Single |
| Sterilized AsepticAlso: aseptic operatory roomOperatory room will be prepared totally aseptic | Procedure or surgery | Sterilized Aseptic - Partial, Sterilized Aseptic Full-Mouth, Sterilized Aseptic Single |
| Sterilized CleanAlso: Clean operatory roomOperatory room will be prepared clean but not aseptic | Procedure or surgery | Sterilized Clean - Partial, Sterilized Clean Full-Mouth, Sterilized Clean Single |
| Full-Mouth Dental ImplantsAlso: Full-mouth rehabilitation, Full mouth implant supported rehabilitationdental implants for full-mouth implant rehabilitation. | Procedure or surgery | Sterilized Aseptic Full-Mouth, Sterilized Clean Full-Mouth |
| Partial RehabilitationAlso: partial implant-supported rehabilitationtwo or more implants to support partial rehabilitation | Procedure or surgery | Sterilized Aseptic - Partial, Sterilized Clean - Partial |
| Duration of SurgeryAlso: Time for implant placementit 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. | Procedure or surgery | Sterilized Aseptic - Partial, Sterilized Aseptic Full-Mouth, Sterilized Aseptic Single, Sterilized Clean - Partial, Sterilized Clean Full-Mouth, Sterilized Clean Single |
Primary outcome
Post-Operatory Complications
Time frame: From Implant Placement (Baseline) to 4 weeks after (T1)
Measure the amount of adverse effects in both groups (aseptic vs clean) that happen between time frame baseline to 4 weeks.
Osseointegration
Time frame: At 8 weeks (T2) after Baseline
Measure the ability of dental implants to integrate into bone in both groups (aseptic vs clean)
2 secondary outcomes
Marginal bone loss
Time frame: At Final Restoration placement - Expected Average of 12 Weeks after baseline
Patient Satisfaction
Time frame: At 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre Chen, Msc principal investigator
University of Lisbon, College of Dentistry
João Caramês, Phd study director
University of Lisbon, College of Dentistry
João Canta, Msc study chair
University of Lisbon, School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Dental Implants, Sterilized Aseptic and Sterilized Clean in people with Endosseous Dental Implant Failure and Bone Loss, run by Implantology Institute at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact André Chen, Msc (00351919774343, tsouchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Operatory Complications (time frame: From Implant Placement (Baseline) to 4 weeks after (T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2013; AzTrials last refreshed its copy on 6 Nov 2026.