Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine | Sham Comparator | Access flap will be raised to gain access to the implant surface. 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. |
|
| Connective Tissue Graft | Other | CTG will be positioned in the buccal aspect of the peri-implant tissue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on probing changes | changes of bleeding on probing, evaluated as present if bleeding will be evident within 30 s after probing, or absent, if no bleeding will be noticed within 30 s after probing | baseline, 3, 6 and 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| clinical attachment level changes | changes in clinical attachment level, measured from CEJ to the tip of the probe | baseline, 3, 6 and 12 months after treatment |
| probing pocket depth changes | changes in probing depth probing, measured from gingival margin to te tip of the probe |
Not provided
Inclusion Criteria:
presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined with:
single tooth and bridgework restorations without overhangs no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment),
treated chronic periodontitis and proper periodontal maintenance care FMPS < 20%
non-smoker or light smoking status in smokers (<10 cigarettes per day) implant function time ≥ 1 year.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| marco clementini | Contact | 0226432806 | mclementini@me.com | |
| De Sanctis | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Massimo De Sanctis | Università Vita-Salute San Raffaele | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Vita-Salute San Raffaele | Recruiting | Milan | 20100 | Italy |
Not provided
| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Connective Tissue Graft | Procedure | CTG will be positioned in the buccal aspect of the peri-implant tissue |
|
| baseline, 3, 6 and 12 months after treatment |
| mucosal recession changes | changes in mucosal recession, measured from CEJ to gingival margin | baseline, 3, 6 and 12 months after treatment |
| bone level changes | changes in bone level at mesial and distal aspect, measured on periapical X-ray | baseline and 12 months after treatment |