Peri-implant bone changes in post-menopausal osteoporotic women
Research type
Research Study
Full title
Radiographic peri-implant alveolar bone changes in post-menopausal osteoporotic women.
IRAS ID
192341
Contact name
Nikolaos Donos
Contact email
Sponsor organisation
Queen Mary University of London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
This is a prospective case series study aiming to evaluate the effect of post-menopausal osteoporosis (disease characterised by a reduction in bone density) on the jaw bone around dental implants with a modified titanium surface. Owing to the increasing life expectancy of the population, it is likely that the number of osteoporotic patients requiring dental care will increase in the near future. Some animal and human studies have reported that osteoporosis may negatively influence bone healing around dental implants and the success of dental implants. SLActive dental implants have a modified titanium surface that accelerates bone formation and may therefore be useful in challenging situation, such as in the presence of osteoporotic bone.
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 SLActive dental implant and 12 months after loading (placement of the crown) it in post-menopausal osteoporotic women.
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 NHS Trust. Oral hygiene instructions and a full-mouth debridement to remove hard and soft deposits from the remaining teeth will be provided before implant placement. A 3-D radiograph (CBCT) will be taken after implant placement and 12 months after implant loading. Control visits for polishing and new oral hygiene instructions will be performed 6 months and 12 months after implant loading.REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/0477
Date of REC Opinion
29 Apr 2016
REC opinion
Further Information Favourable Opinion