Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-07-02
2021-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Chlorhexidine
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.
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.
Connective Tissue Graft
CTG will be positioned in the buccal aspect of the peri-implant tissue
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.
Connective Tissue Graft
CTG will be positioned in the buccal aspect of the peri-implant tissue
Interventions
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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.
Connective Tissue Graft
CTG will be positioned in the buccal aspect of the peri-implant tissue
Eligibility Criteria
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Inclusion Criteria
1. PPD ≥ 5 mm and bone loss ≥ 2 mm (compared to crestal bone levels at the time of placement of the reconstruction)
2. PPD ≥6 and bone loss ≥3 (not compared to crestal bone levels at the time of placement of the reconstruction)
* 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
* patients with osteoporosis or under bisphosphonate medication,
* pregnant or lactating women
* patients with a history of radiotherapy to the head and neck region hollow implants
* implant mobility
* implants at which no position could be identified where proper probing measurements could be performed;
* previous surgical treatment of the peri-implantitis lesions
18 Years
100 Years
ALL
Yes
Sponsors
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Università Vita-Salute San Raffaele
OTHER
Responsible Party
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Marco Clementini
Principal Investigator
Principal Investigators
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Massimo De Sanctis
Role: STUDY_CHAIR
Università Vita-Salute San Raffaele
Locations
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Università Vita-Salute San Raffaele
Milan, , Italy
Countries
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Central Contacts
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De Sanctis
Role: CONTACT
Facility Contacts
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marco clementini
Role: primary
Other Identifiers
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peri-implant surgical-3
Identifier Type: -
Identifier Source: org_study_id