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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
80
place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.
Operatory room will be prepared totally aseptic
Operatory room will be prepared clean but not aseptic
University of Lisbon, School of Dentistry
Lisbon, Lisbon District, Portugal
Post-Operatory Complications
Measure the amount of adverse effects in both groups (aseptic vs clean) that happen between time frame baseline to 4 weeks.
Time frame: 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)
Time frame: At 8 weeks (T2) after Baseline
Marginal bone loss
measure the amount of marginal bone loss at the time of final restoration placement
Time frame: At Final Restoration placement - Expected Average of 12 Weeks after baseline
Patient Satisfaction
measure the amount of post-operatory discomfort of the patient
Time frame: At 2 weeks
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dental implants for full-mouth implant rehabilitation.
two or more implants to support partial rehabilitation
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.