Osteoporosis, Postmenopausal Clinical Trial
Official title:
Radiographic Peri-implant Alveolar Bone Changes in Post-menopausal Osteoporotic Women
NCT number | NCT02884401 |
Other study ID # | 010890 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | August 30, 2022 |
Verified date | February 2022 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | August 30, 2022 |
Est. primary completion date | March 15, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Participants must present a diagnosis of osteoporosis based on DXA measurement of the bone mineral density at the femur neck and/or total hip and/or lumbar spine (T value 2.5 SD or more below the young female adult mean) within the past 24 months. - Not in treatment with anti-resorptive agents (like bisphosphonates and denosumab) for more than 4 consecutive years, in order to reduce the risk of medication-related osteonecrosis of the jaws (Lo et al., 2010). - = 50 years old. - In self-reported menopause, defined as the permanent cessation of ovulation, for at least one year (Soules et al., 2001). - Edentulous area involving a maximum of two teeth (wisdom teeth and second molars are excluded) and presenting at least one neighbouring tooth (e.g. gap in the area of a second premolar and first molar, with first premolar in place). - Residual alveolar width = 4 mm (Milinkovic and Cordaro, 2014), residual alveolar height >8 mm, enough inter-arch space for a crown (at least 5 mm) and a minimum distance of 7 mm from the adjacent teeth (Shah and Lum, 2008). The width and height will be confirmed after x-ray examination in Visit 2. - Possibility to restore a functional occlusion with a minimum of four occlusal units (i.e. pairs of occluding posterior teeth). - Willingness to replace the missing tooth/teeth with dental implants - Registration with a GDP Exclusion Criteria: - On chronic treatment (i.e., two weeks or more) with any medication severely affecting oral status (e.g. participants with gingival hypertrophy caused by anti-epileptics, calcium antagonists, cyclosporine and other immunosuppressive) or bone metabolism (e.g. anticoagulant medications, long-standing steroid medications -i.e. equal or more 2.5mg of prednisolone a day taken for >3 months -, anticonvulsants, immunosuppressants). - Affected by systemic diseases recognized to severely affect bone metabolism (e.g. Cushing's syndrome, Addison's disease, diabetes mellitus type 1, leukaemia, pernicious anaemia, malabsorption syndromes, chronic liver disease, rheumatoid arthritis). - Knowingly affected by HIV or Hepatitis. - History of local radiation therapy in the last five years. - Affected by limited mental capacity or language skills such that study information cannot be understood, informed consent cannot be obtained, or simple instructions cannot be followed. - Presenting an acute endodontic/periodontal lesion in the neighboring areas to the implant site. - Completely edentulous - With evident severe atrophy of the alveolar ridge that could preclude an implant placement (e.g. sharp knife edge ridge) - Severe bruxism or clenching habits - Smokers of > 5 cigarettes a day. - A daily alcohol intake >2 units/day. - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality which may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this trial. - Patients unable or not willing to return for follow-ups. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Centre for Oral Clinical Research, Institute of Dentistry, Barts Health, QMUL | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London |
United Kingdom,
Buser D, Broggini N, Wieland M, Schenk RK, Denzer AJ, Cochran DL, Hoffmann B, Lussi A, Steinemann SG. Enhanced bone apposition to a chemically modified SLA titanium surface. J Dent Res. 2004 Jul;83(7):529-33. — View Citation
Calciolari E, Donos N, Park JC, Petrie A, Mardas N. A systematic review on the correlation between skeletal and jawbone mineral density in osteoporotic subjects. Clin Oral Implants Res. 2016 Apr;27(4):433-42. doi: 10.1111/clr.12597. Epub 2015 Apr 12. Review. — View Citation
Dao TT, Anderson JD, Zarb GA. Is osteoporosis a risk factor for osseointegration of dental implants? Int J Oral Maxillofac Implants. 1993;8(2):137-44. Review. — View Citation
Donos N, Hamlet S, Lang NP, Salvi GE, Huynh-Ba G, Bosshardt DD, Ivanovski S. Gene expression profile of osseointegration of a hydrophilic compared with a hydrophobic microrough implant surface. Clin Oral Implants Res. 2011 Apr;22(4):365-72. doi: 10.1111/j.1600-0501.2010.02113.x. — View Citation
Lang NP, Salvi GE, Huynh-Ba G, Ivanovski S, Donos N, Bosshardt DD. Early osseointegration to hydrophilic and hydrophobic implant surfaces in humans. Clin Oral Implants Res. 2011 Apr;22(4):349-56. doi: 10.1111/j.1600-0501.2011.02172.x. — View Citation
Mardas N, Schwarz F, Petrie A, Hakimi AR, Donos N. The effect of SLActive surface in guided bone formation in osteoporotic-like conditions. Clin Oral Implants Res. 2011 Apr;22(4):406-15. doi: 10.1111/j.1600-0501.2010.02094.x. Epub 2011 Feb 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in peri-implant horizontal and vertical alveolar bone | 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. | After implant placement (+10 days) and 12 months after implant loading (± 14 days) | |
Secondary | changes in implant stability measured with resonance frequency analysis | 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. | 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. | |
Secondary | Implant success | Buser et al (1990) criteria will be used to evaluate implant success 12 months after loading (± 14 days) | 12 months after loading (± 14 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03931109 -
Circulating miRNA in Primary Hyperparathyroidism
|
||
Not yet recruiting |
NCT03232476 -
Effect of Mechanical Loading With PTH on Cortical Bone
|
Phase 4 | |
Completed |
NCT00073190 -
Patient- and Physician-Based Osteoporosis Education
|
Phase 1 | |
Completed |
NCT00402441 -
Risedronate in the Prevention of Osteoporosis in Postmenopausal Women
|
Phase 4 | |
Completed |
NCT03710889 -
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
|
Phase 3 | |
Completed |
NCT00010712 -
Effects of Black Cohosh on Menopausal Hot Flashes
|
Phase 2 | |
Recruiting |
NCT05058976 -
Romosozumab Use to Build Skeletal Integrity
|
Phase 4 | |
Active, not recruiting |
NCT05405894 -
Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
|
||
Recruiting |
NCT03337971 -
Nutritional Supplement and Bone Health in Post-Menopausal Women
|
N/A | |
Completed |
NCT03701113 -
Milk Protein and Bone Health in Postmenopausal Women
|
N/A | |
Completed |
NCT01381588 -
The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women
|
N/A | |
Completed |
NCT00383422 -
Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis
|
Phase 3 | |
Completed |
NCT00549965 -
Satisfaction and Compliance of Risedronate in PMO
|
Phase 4 | |
Completed |
NCT00035256 -
Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis
|
Phase 4 | |
Completed |
NCT01386281 -
Julina Post-marketing Surveillance for Climacteric Symptoms in Japan
|
||
Completed |
NCT05266261 -
Use of Ibandronate in Diabetic Patients
|
N/A | |
Recruiting |
NCT04964388 -
Effect of GLP-1 Receptor Agonists on Trabecular Bone Score
|
Phase 2 | |
Active, not recruiting |
NCT03623633 -
Comparative Antiresorptive Efficacy Discontinuation of Denosumab
|
Phase 4 | |
Recruiting |
NCT05575167 -
Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)
|
||
Recruiting |
NCT06164795 -
Sequential Therapies After Osteoanabolic Treatment
|