Radiographic Peri-implant Alveolar Bone Changes in Post-menopausal Osteoporotic Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Changes in peri-implant horizontal and vertical alveolar bone
研究概览
简要总结
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.
详细描述
This is a prospective case series study aiming to radiographically assess the changes in alveolar bone width and height after the placement of a SLActive implant (implant with a modified surface that should stimulate bone formation) and 12 months after loading it in post-menopausal osteoporotic women. The null hypothesis is: in post-menopausal osteoporotic women there are no significant changes in the peri-implant alveolar bone after the placement of a SLActive implant and 12 months after loading it in terms of width and height assessed by the use of CBCT images. The aim is to include 20 post-menopausal osteoporotic women with a requirement of a tooth to be replaced. However, considering a potential drop-out rate of 10%, the investigators have planned to increase the recruitment for this trial to 22 postmenopausal women. They will be recruited from the Rheumatology Department and Radiology Department at Barts Health NHS Trust, amongst those patients attending for a consultation with the osteoporosis specialist or for taking a Dual-energy X-ray absorptiometry (DXA) scan. Before starting the visit, post-menopausal women meeting the inclusion criteria will be asked by a study examiner if they agree to be quickly screened for the presence of an intercalate edentulous area (edentulous area in between the teeth)and if they may be interested in taking part into the study. If they agree, a quick dental examination will be performed by a study examiner (a qualified dentist) after the visit. The patients who would qualify for enrolment will receive information on the study, the patient information sheet and consent form, together with a letter to give to their General Dental Practitioner (GDP) in order to be referred to the Centre for Oral Clinical Research. The patients that do not qualify for enrolment will receive a report of the oral screening in case they require dental treatments.
Once the referral letter arrives at the Centre for Oral Clinical Research, Barts Health, the patient will be contacted to answer any further question and to book an appointment to attend the enrolment visit, should they wish.
The study consists of 8 visits that will be performed over a minimum period of 15 months at the Centre for Oral Clinical Research at the School of Dentistry of Queen Mary University of London (QMUL):
- Enrollment visit:
- Signing of informed consent;
- Recording of any concomitant medication;
- Confirmation of participant eligibility pertaining to the presence of an intercalate single edentulous area fulfilling the inclusion criteria (wisdom teeth and second molars excluded)
- Basic Periodontal Examination (BPE) recording;
- Clinical measurement of the periodontal parameter in the teeth adjacent to the area where the implant will be placed (Probing pocket Depth, PPD; Recession, REC; Plaque Index, PI; Bleeding on Probing, BOP)
- Exit participant if not eligible, arrangement for full-mouth debridement treatment outside the study protocol (if needed) and refer to GDP for other dental problems (such as caries and endodontic infections).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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.
结局指标
主要结局
Changes in peri-implant horizontal and vertical alveolar bone
时间窗: 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.
次要结局
- 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))