Mario Pérez Sayáns
Santiago de Compostela, A Coruña, 15785, Spain
NCT Number: NCT03720236
This is a randomized triple-blind clinical trial to evaluate the behavior of peri-implant tissues (bone and soft tissues) in BLX implants loaded early or delayed and with different surgical milling protocols. To this end, 40 BLX implants with a diameter of 3.75x10 will be placed in areas of mature bone scarred after extraction. They will be divided into 2 study groups, and these in turn into two subgroups. Group A: complete milling, Group B: partial milling. Each group will be assigned with code 1: early load and code 2: deferred load. Clinical and radiological parameters will be evaluated.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Santiago de Compostela, A Coruña, 15785, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is the first surgical phase, we prepare the implant bed by using different increasing size drills.
Other names: IBP
This is the second phase, based on prosthetic procedures, to design the crown over the dental implant
Other names: IL
Time frame: 12 months
Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol (n = 20) and with the preparation protocol with under-fresh (n = 20). We will evaluate the immediate post-surgical stability of implants and peri-implant tissues through the Ostell system, based on the resonance frequency analysis (RFA). The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ
Time frame: 1 day
Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol (n = 20) and with the preparation protocol with under-fresh (n = 20). We will load the crowns in two different groups, code 1: loading the implants before 7 days after surgery; code 2: before 8 weeks after implant surgery. We will evaluate the stability at different moments, 8 weeks, 6 months and 12 months.The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ. ISQ values are obtained using resonance frequency analysis (RFA).
Time frame: 1 day
At the moment of placing the implant a periapical radiography will be performed, considering this measure the basal radiological bone level (distance from the neck of the implant to the most crestal level of the alveolar bone). We will calculate the difference between the basal measure and the future measurements.
Time frame: 1 day
At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. We will calculate the difference between the basal measure and the future measurements.
Time frame: 6 weeks
After the implantation, we´ll load the temporary prostheses in two different moments, 7 days or 8 weeks depending of the aleatory coding. We will evaluate the bone level stability at 6 weeks in both groups. The bone stability will be measured as a difference between de basal bone level and the actual one in mm.
Time frame: 6 weeks
After the implantation, we´ll load the temporary prostheses in two different moments, 7 days or 8 weeks depending of the aleatory coding. We will evaluate the peri-implant tissue stability by measuring the probing depth or just in case, the recession of the gingival margin. The stability will be gave by the differences between both measures, basal and actual in mm.
Time frame: 6 weeks
After the implantation, we´ll load the temporary prostheses in two different moments, 7 days or 8 weeks depending of the aleatory coding. We will evaluate the peri-implant tissue stability by measuring the ISQ through RFA. The stability will be gave by the differences between both measures, basal and actual.
Time frame: 6 months
The final or definitive prostheses will be inserted in all groups at 6 months. At this time, we will measure the clinical probing depth, comparing with previous measurements.
Time frame: 6 months
The final or definitive prostheses will be inserted in all groups at 6 months. At this time, we will measure the implant stability through RFA, comparing with previous measurements.
Time frame: 6 months
The final or definitive prostheses will be inserted in all groups at 6 months. At this time, we will measure the bone implant level by measuring the distance from de implant neck to the most apical inserted bone, comparing simultaneously with previous measurements.
Time frame: 12 months
After 6 months of loading of final ceramic restoration, we will evaluate the differences of clinical (mm of probing depth, ISQ implant stability) and radiological aspects (bone implant level in mm calculated from the neck to the actual bone level, comparing on the basal, the intermediate, and final values.
University of Santiago de Compostela
Other
Behavior of Peri-implant Tissues in BLX® Implants Placed on Mature Scarred Bone
Acronym: BLX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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