Peri-implant Bone Changes in Post-menopausal Osteoporotic Women
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|ClinicalTrials.gov Identifier: NCT02884401|
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : April 24, 2018
This is a prospective case series study aiming to evaluate the effect of post-menopausal osteoporosis on the jaw bone around dental implants with a modified titanium surface. The study consists of 8 visits that will be performed within a minimum period of 15 months. Participants will be recruited from the Rheumatology Department and Radiology Department at Barts Health National Health Service (NHS) Trust.
Participants will include 20 post-menopausal osteoporotic women with a requirement of a tooth to be replaced. The main objective of this study is to radiographically compare alveolar (jaw) bone changes in width and height after the placement of a dental implant with a hydrophilic (SLActive) surface and 12 months after loading (placement of the crown) it in post-menopausal osteoporotic women.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis, Postmenopausal||Device: Dental implant placement (Straumann® Bone Level Tapered, BLT, Roxolid® SLActive®)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radiographic Peri-implant Alveolar Bone Changes in Post-menopausal Osteoporotic Women|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||February 28, 2020|
osteoporotic women with a missing tooth
Post-menopausal osteoporotic women with a missing tooth and willing to replace it with a dental implant
Device: Dental implant placement (Straumann® Bone Level Tapered, BLT, Roxolid® SLActive®)
A tapered bone level implant (Straumann® BLT Roxolid® SLActive®, Basel, Switzerland) will be placed according to the manufactures guidelines trying to achieve primary stability in the correct prosthetic position
- Changes in peri-implant horizontal and vertical alveolar bone [ Time Frame: After implant placement (+10 days) and 12 months after implant loading (± 14 days) ]The peri-implant alveolar bone changes in height and width (in mm) will be assessed with the use of a CBCT scan after the implant placement (+10 days) and 12 months post loading (± 14 days). A single calibrated examiner will take all the measurements 3 times and the average value will be recorded. All measurements will be calculated with a 0.1 mm precision level.
- changes in implant stability measured with resonance frequency analysis [ Time Frame: at implant placement, suture removal (7 days + 3 days after implant placement), implant impression (6 weeks ± 7 days after implant placement), implant loading (8 weeks ± 7 days after implant placement), at 6 months- (± 14 days) and 12 months- follow ups. ]Resonance frequency analysis will be used to evaluate implant stability. Implant stability quotient (ISQ) will be recorded after implant placement, suture removal (7 days + 3 days after implant placement), implant impression (6 weeks ± 7 days after implant placement), implant loading (8 weeks ± 7 days after implant placement), at 6 months- (± 14 days) and 12 months- follow ups.
- Implant success [ Time Frame: 12 months after loading (± 14 days) ]Buser et al (1990) criteria will be used to evaluate implant success 12 months after loading (± 14 days)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884401
|Contact: Nikolaos Donos, Proffirstname.lastname@example.org|
|Contact: Elena Calciolari, Dremail@example.com|
|Centre for Oral Clinical Research, Institute of Dentistry, Barts Health, QMUL||Recruiting|
|London, United Kingdom, E1 2AD|
|Contact: Shirley Goodey, Centre Admin 0207 882 ext 3076 firstname.lastname@example.org|
|Contact: Lisa Groarke, Senior Nurse 0207 882 ext 8641 email@example.com|
|Principal Investigator:||Nikolaos Donos, Prof||Queen Mary University of London|