Bone Loss, Endosseous Dental Implant Failure
Conditions
Keywords
aseptic sterilized field, clean sterilized field, dental implants, Surgery
Brief 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 ?
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.
Interventions
PROCEDUREDuration 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.
PROCEDURESingle Dental Implants
place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.
PROCEDURESterilized Aseptic
Operatory room will be prepared totally aseptic
PROCEDURESterilized Clean
Operatory room will be prepared clean but not aseptic
PROCEDUREFull-Mouth Dental Implants
dental implants for full-mouth implant rehabilitation.
PROCEDUREPartial Rehabilitation
two or more implants to support partial rehabilitation
Sponsors
Implantology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All surgeries schedule for implant placement
Exclusion criteria
* Surgeries not made with local anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Operatory Complications | 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 | At 8 weeks (T2) after Baseline | Measure the ability of dental implants to integrate into bone in both groups (aseptic vs clean) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal bone loss | At Final Restoration placement - Expected Average of 12 Weeks after baseline | measure the amount of marginal bone loss at the time of final restoration placement |
| Patient Satisfaction | At 2 weeks | measure the amount of post-operatory discomfort of the patient |
Countries
Portugal
Contacts
Primary ContactAndré Chen, Msc
Outcome results
None listed