Peri-implant Bone Changes in Post-menopausal Osteoporotic Women

NCT02884401 | Completed

• 1 other identifier: 010890
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• changes in implant stability measured with resonance frequency analysis

  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.

• Implant success

  12 months after loading (± 14 days)

Study Arms (1)

osteoporotic women with a missing tooth

OTHER

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®)

Interventions

Dental implant placement (Straumann® Bone Level Tapered, BLT, Roxolid® SLActive®) DEVICE

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

osteoporotic women with a missing tooth

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Centre for Oral Clinical Research, Institute of Dentistry, Barts Health, QMUL

London, E1 2AD, United Kingdom

Location

Related Publications (7)

• 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. doi: 10.1177/154405910408300704.

  PMID: 15218041 BACKGROUND

• 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.

  PMID: 25864584 BACKGROUND

• 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.

  PMID: 8359868 BACKGROUND

• 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.

  PMID: 21561478 BACKGROUND

• 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.

  PMID: 21561476 BACKGROUND

• 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.

  PMID: 21303420 BACKGROUND

• Elena C, Nikos M, Iro P, Sara T, Nikolaos D. Radiographic Peri-Implant Bone Changes in Osteoporotic Women Treated With a Ti-Zr, Bone Level Tapered Implant With a Hydrophilic Surface: A 12-Month Prospective Case-Series. Clin Oral Implants Res. 2025 Oct;36(10):1234-1247. doi: 10.1111/clr.14469. Epub 2025 Jul 8.

  PMID: 40625220 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nikolaos Donos, Prof

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: August 31, 2016
• Study Start: September 1, 2016
• Primary Completion: March 15, 2022
• Study Completion: August 30, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)