Resolution of Pathologic Process
Conditions
Brief summary
With the growing burden of peri-implantitis around the globe, interest has flourished on the management of this pathology. Nevertheless, lack of consensus exists in the pursuit of a predictable therapy. Different therapeutic modalities have been advocated. Non-surgical therapy as a sole modality is often insufficient to resolve inflammation. Surgical interventions have demonstrated more favorable outcomes. Amongst these, evidence supported the application of resective, reconstructive, or combined approaches to limit progressive bone loss and achieve soft tissue health. Nevertheless, up to date, the most suitable modality remains unknown and the decision-making process derives from the understanding acquired from the management of periodontitis. One critical element regarded to successfully resolve peri-implantitis is to efficiently detoxify the contaminated implant surface. Mechanical, pharmacological and chemical strategies have been proposed to eliminate bacterial plaque and remnants from the implant surface. However, evidence has not demonstrated superiority of a given detoxification agent/strategy. In this sense, the significance of barrier membranes is not yet well understood. Roos-Jansaker in 2014 showed that the additional use of barrier membranes did not improve the outcome. Nevertheless, since then this subject has not been a matter of research.
Detailed description
The effect of barrier membrane in the reconstructive management of peri-implantitis will be tested at 12-month follow-up
Interventions
PROCEDUREReconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group)
A full-thickness flap was raised to ensure sufficient access. Debridement of granulation tissue was subsequently conducted using a mini-five curette (Hu-Friedy) and site-specific Gracey curettes (Hu-Friedy). The surgical approach was tailored to the clinical scenario. Specifically, resective therapy by means of implantoplasty was performed for supracrestal defects (Meisinger LLC, Nauss, Germany). Surface detoxification was performed with 3% hydrogen peroxide during 2 minutes and irrigation with 0.12% chlorhexidine. The intraosseous compartment was grafted using mineralized and demineralized bone graft (LifeNet Health, Virginia, USA). The graft was compartmentalized in the test group with a collagen porcine resorbable membrane (RTM, Cytoplast, California, USA) adapted to the defect morphology. Nylon 5.0 (Resorba Sutures, Osteogenics Biomedical, Lubbock, Texas) was used for suturing, ensuring primary wound closure
Sponsors
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Non-smokers * No use of antibiotics recently * No metabolic disorder * Infra-osseous or combined peri-implantitis defect
Exclusion criteria
* Smokers * Pregnant * Metabolic disorders that affect bone healing * Supra-crestal defects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in clinical parameters | 12 months | Number of patients where the disease was resolved. At implant level the changes in bleeding on probing and changes in probing pocket depths will be recorded as well |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Bone level | 12-month follow-up | Change in Bone level measured in mm from x-rays obtained from the comparative between baseline bone level and bone level determined at 12-month follow-up |
Countries
Spain
Outcome results
None listed