- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03977324
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: De Sanctis
Study Locations
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-
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Milano, Italy, 20100
- Recruiting
- Università Vita-Salute San Raffaele
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined with:
- PPD ≥ 5 mm and bone loss ≥ 2 mm (compared to crestal bone levels at the time of placement of the reconstruction)
- 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 uncontrolled diabetes
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Connective Tissue Graft
CTG will be positioned in the buccal aspect of the peri-implant tissue
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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.
CTG will be positioned in the buccal aspect of the peri-implant tissue
|
SHAM_COMPARATOR: 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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bleeding on probing changes
Time Frame: baseline, 3, 6 and 12 months after treatment
|
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
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baseline, 3, 6 and 12 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical attachment level changes
Time Frame: baseline, 3, 6 and 12 months after treatment
|
changes in clinical attachment level, measured from CEJ to the tip of the probe
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baseline, 3, 6 and 12 months after treatment
|
probing pocket depth changes
Time Frame: baseline, 3, 6 and 12 months after treatment
|
changes in probing depth probing, measured from gingival margin to te tip of the probe
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baseline, 3, 6 and 12 months after treatment
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mucosal recession changes
Time Frame: baseline, 3, 6 and 12 months after treatment
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changes in mucosal recession, measured from CEJ to gingival margin
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baseline, 3, 6 and 12 months after treatment
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bone level changes
Time Frame: baseline and 12 months after treatment
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changes in bone level at mesial and distal aspect, measured on periapical X-ray
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baseline and 12 months after treatment
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- peri-implant surgical-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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