Peri-implantitis and Systemic Inflammation (LASSO)
Research type
Research Study
Full title
Local and Systemic Effects of Peri-implantitis and its Treatment (LASSO). A Randomised Controlled Clinical Trial
IRAS ID
257884
Contact name
Francesco D'Aiuto
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2019/08/94, UCL Data Protection Registration
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
There is established evidence supporting links between periodontitis and systemic inflammation, however, the link between peri-implantitis and systemic inflammation is unclear. Studies have showed a more profound inflammatory response at the local level around implants with peri-implantitis, analogous to more aggressive patterns of periodontitis. The potential effects of peri-implantitis on systemic health is worth exploring due to implications for general and systemic health of patients.
Additionally, there is currently a lack of clarity with regards the ideal treatment of peri-implantitis with both non-surgical and surgical therapy being explored with inconclusive results in the literature. Decontamination of the implant surface is thought to be a key element in eliminating inflammation. Therefore, there is merit in investigating different treatment modalities to explore their clinical impact and their effects on local and systemic markers of inflammation.
The aim of this study is to investigate clinical, immunological, microbiological and vascular parameters in patients with peri-implantitis to assess the extent of the inflammatory response and its local and systemic effects both at baseline and following different treatments. Different treatment modalities will also be compared to examine the effect on different outcome parameters.
Adult participants (18 years or older) with signs and symptoms of peri-implantitis and meeting the inclusion criteria as well as healthy controls will be recruited and balanced for weight, gender, smoking, age and ethnicity.
A sample size calculation identified that 138 participants (60 healthy controls and 78 peri-implantitis test cases) will need to be recruited. The 78 peri-implantitis cases will subsequently be randomised in to 3 equal treatment groups of 26 participants to receive one of three treatment modalities for peri-implantitis: non-surgical hand debridement, or non-surgical air abrasive debridement, or surgical air abrasive debridement. Sample collection and assessments will take place at Baseline, Treatment, 3 and 6 month post treatment.
REC name
North East - York Research Ethics Committee
REC reference
19/NE/0365
Date of REC Opinion
6 Jan 2020
REC opinion
Further Information Favourable Opinion