This study is initiated to support the OsseoSpeedTM TX implant with clinical data showing that a soft bone drilling protocol and immediate loading does not have any important negative effect on marginal bone level maintenance.
This study is designed to evaluate a soft bone drilling protocol compared to a standard bone drilling protocol when using OsseoSpeedTM TX with regards to marginal bone level changes and implant survival rate one year after loading. The aim is also to investigate potential differences in initial stability and in general user friendliness between the two drilling protocols.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
OsseoSpeed TX dental implants, 6-17 mm
Studio Associato Maffei
Bari, Italy
Studio Dentistico Paolo Torrisi
Catania, Italy
Societa diMedicina Odontostomatologica Srl
Como, Italy
Dept. of Oral Sciences "S. Palazzi", University of Pavia
Pavia, Italy
Marginal Bone Level Change
Marginal Bone Level alterations will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.
Time frame: Implant insertion and 12 months post implant insertion
Marginal Bone Level Change
Marginal Bone Level alterations will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.
Time frame: Implant insertion and 3 months post implant insertion
Implant Survival Rate
Implant survival rate will be evaluated by both clinically and radiographically counting the number of remaining implants from implant placement to one year after loading.
Time frame: 12 months after baseline, i.e., implant insertion
Implant Stability Assessed Clinically/Manually
Evaluated clinically/manually and recorded as stable yes/no.
Time frame: At implant insertion
Implant Stability Using Resonance Frequency Analysis (RFA)
The Osstell® instrument "Osstell® ISQ" will be used to measure RFA. RFA measures the frequency with which a device vibrates. By comparing resonance frequencies the stability of a dental implant can be determined as the resonance frequency changes with different stability. The Osstell® ISQ instrument translates the RFA value into an Implant Stability Quotient (ISQ) scale value. ISQ is a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro mobility, with a higher value corresponding to increased stability.
Time frame: At implant insertion.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Studio Dentistico
Perugia, Italy
La Scala & Partners Studio Associato
Pistoia, Italy
Studio Odontoiatrico
Roma, Italy
Studio Dentistico
Torino, Italy
Studio Polispecialistico di Odontoiatria
Udine, Italy
Perception During Implant Insertion - "The Implant Was Guided Into the Prepared Osteotomy"
After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy" and "The implant has a good primary stability". The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.
Time frame: After implant insertion
Perception During Implant Insertion - "The Implant Followed the Prepared Osteotomy"
After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy" and "The implant has a good primary stability". The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.
Time frame: After implant insertion
Perception During Implant Insertion - "The Implant Has a Good Primary Stability"
After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy" and "The implant has a good primary stability". The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.
Time frame: After implant insertion