Trials / Unknown
UnknownNCT03977324
Surgical Protocol for Peri-Implantitis Treatment-3
Surgical Protocol for Peri-implantitis in Horizontal Defect in Absence of Keratinised Tissue Using Chemical Decontamination With Chlorhexidine and a CTG: a Randomized Clinical Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Università Vita-Salute San Raffaele · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Accepted
Summary
Peri-implant diseases are common post-restorative complications in implant rehabilitations and they occur with an incidence of 12-43%. Based on the available data in literature, the surgical therapy for peri-implantitis is effective in disease resolution. Surgical access to peri-implant lesions facilitates the removal of all granulation tissue from the defect area as well as debridement and decontamination of the exposed implant surface defect area. Different techniques have been used for implant surface decontamination during peri-implant surgery, including mechanical, chemical and laser treatments.
Detailed description
Peri-implantitis are defined as inflammatory diseases caused by bacterial biofilm around implant surface characterized by bleeding on probing, probing depth and eventually bone loss; if not successfully treated they may lead to implant loss. Based on the available parameters that have been reported in literature non surgical therapy doesn't seem to be effective on peri-implantitis. Therefore it is recommended to consider advanced therapies such as surgical interventions when non surgical peri-implant therapy fails to achieve significant improvements in clinical parameters. Numerous approaches have been used for implant surface decontamination during per-implant surgery, including mechanical, chemical and laser treatments. Conventional mechanical means don't seem to be effective on peri-implant diseases. In addition, the rough implant surface is a retentive factor for bacterial colonization and therefore makes implant surface difficult to debride. Another problem in maintaining implant health concerns the presence or absence of keratinised tissue around implant: if present, it seams to help the patient to maintain an optimal level of oral hygiene around implant and therefore the implant survival itself. The aim of the present randomized controlled clinical trial is to assess the influence of keratinised tissue around implant in improving clinical parameters. In particular, implant surface will be decontaminated mechanically with titanium curettes and chemically using chlorhexidine; after this a CTG around tissue implant will be randomized
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Chlorhexidine | Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine. |
| PROCEDURE | Connective Tissue Graft | CTG will be positioned in the buccal aspect of the peri-implant tissue |
Timeline
- Start date
- 2018-07-02
- Primary completion
- 2020-12-30
- Completion
- 2021-12-31
- First posted
- 2019-06-06
- Last updated
- 2020-11-03
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03977324. Inclusion in this directory is not an endorsement.