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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
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London

Brief Summary:

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Nikolaos Donos, Prof n.donos@qmul.ac.uk
Contact: Elena Calciolari, Dr e.calciolari@qmul.ac.uk

Locations
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United Kingdom
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    s.a.goodey@qmul.ac.uk   
Contact: Lisa Groarke, Senior Nurse    0207 882 ext 8641    l.groarke@qmul.ac.uk   
Sponsors and Collaborators
Queen Mary University of London
Investigators
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Principal Investigator: Nikolaos Donos, Prof Queen Mary University of London

Publications:
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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT02884401     History of Changes
Other Study ID Numbers: 010890
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases