Non Surgical Protocol for Treatment of Peri-implantitis
Primary Purpose
Peri-Implantitis
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
mechanical debridement and chemical decontamination
Er:YAG laser
Air Powder
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis focused on measuring non surgical therapy, laser, air powder, chlorhexidine
Eligibility Criteria
Inclusion Criteria:
presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined with:
- a PPD ≥ 5 mm and bone loss ≥ 2 mm (compared to crestal bone levels at the time of placement of the reconstruction)
- a PPD ≥ 6 mm and bone loss ≥ 3 mm (not compared to crestal bone levels at the time of placement of the reconstruction)
- single tooth and bridgework restorations without overhangings
- no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment)
- 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
- patients with incapability to perform basal oral hygiene measures due to physical or mental disorders
- 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
Sites / Locations
- Università Vita-Salute San RaffaeleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Active Comparator
Arm Label
Chlorhexidine
Er:YAG laser
Air Powder
Arm Description
mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant surface will be cleaned by copious irrigation with Chlorhexidine.
Er:YAG laser treatment will be provided on the implant surface.
an Air-Powder treatment will be provided on the implant surface.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
probing pocket depth changes
changes in probing pocket depth, measured from the mucosal margin to the bottom of the probeable pocket
mucosal recession changes
changes in mucosal recession, measured from the mucosal margin to the restoration margin or implant neck
clinical attachment level changes
changes in clinical attachment level, measured from the restoration margin or implant neck to the bottom of the probeable pocket at six aspects per implant (mesio-vestibular, mid-vestibular, disto-vestibular, mesio-oral, mid-oral, and disto-oral.
Full Information
NCT ID
NCT03451981
First Posted
February 20, 2018
Last Updated
November 2, 2020
Sponsor
Università Vita-Salute San Raffaele
1. Study Identification
Unique Protocol Identification Number
NCT03451981
Brief Title
Non Surgical Protocol for Treatment of Peri-implantitis
Official Title
Non Surgical Protocol for Treatment of Peri-implantitis Using an Er:YAG Laser or an Air-abrasive Device: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Vita-Salute San Raffaele
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Peri-implantitis are important disease entities as a result of their high prevalence and the lack of a standard mode of therapy.
Non-surgical therapy of peri-implant disease, especially when bone loss is not high, appears to be partially effective in resolving the disease. In several cases, however, only limited improvements have been reported in the main clinical parameters (bleeding at the survey and presence of the pocket) and there is a clear tendency to relapse of the disease.
In these cases it is therefore recommended to consider adjunctive therapies. Numerous approaches have been used for implant surface decontamination including mechanical, chemical and treatments by means of air-powder or laser.
The aim of the present randomized controlled clinical trial will be to assess the efficacy in improving clinical parameters of two further methods of implant surface decontamination (Er:YAG laser or air-abrasive device) after mechanical and chemical cleaning during non surgical treatment of peri-implantitis.
Detailed Description
Peri-implantitis, defined as an inflammatory lesion in the surrounding peri-implant tissues with loss of supporting bone, are important disease entities as a result of their high prevalence and the lack of a standard mode of therapy. Although the current epidemiological data are limited, peri-implantitis affects 28-56% of the subjects and 12-43% of the implants.
Numerous approaches have been used for implant surface decontamination during peri-implant surgery, including mechanical, chemical and laser treatments. Using conventional mechanical means, eradication of pathogens on implant surfaces with threads and often with rough surface structures is difficult. Treatment models, such as debridment, effectively used to treat teeth with periodontitis, cannot be used in the same way on rough threaded implant surfaces. The implant rough surface structure also provides the bacteria with ''protected areas'', inaccessible to conventional mechanical removal.
A treatment protocol that may offer an advantage over traditional mechanical treatment includes the use of laser therapy. Data have shown that treatments with Er:YAG lasers have a bactericidal effect. Er:YAG laser treatment can debride the implant surface effectively and safely. Slightly better clinical results in terms of bleeding on probing and clinical attachment level have been reported by Er:YAG laser treatment as compared with traditional non-surgical mechanical debridement with curette and chlorhexidine.
The air abrasive method for the removal of bacterial plaque on tooth surfaces has also been used in the treatment of peri-implantitis, demonstrating no relevant adverse effects. Until recently, air-polishing devices have used a slurry of water and sodium bicarbonate (NaHCO3) and pressurized air/water. A less abrasive method using an amino acid glycine has been proven to be effective in removing bacterial biofilm structures in deep periodontal pockets and safe by not causing emphysema. Moreover the use of a glycine-based powder does not seem to cause titanium implant surface changes.
The aim of the present randomized controlled clinical trial will be to assess the efficacy in improving clinical parameters of two further methods of implant surface decontamination (Er:YAG laser or air-abrasive device) after mechanical and chemical cleaning during non surgical treatment of peri-implantitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
non surgical therapy, laser, air powder, chlorhexidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine
Arm Type
Sham Comparator
Arm Description
mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant surface will be cleaned by copious irrigation with Chlorhexidine.
Arm Title
Er:YAG laser
Arm Type
Experimental
Arm Description
Er:YAG laser treatment will be provided on the implant surface.
Arm Title
Air Powder
Arm Type
Active Comparator
Arm Description
an Air-Powder treatment will be provided on the implant surface.
Intervention Type
Procedure
Intervention Name(s)
mechanical debridement and chemical decontamination
Other Intervention Name(s)
curette and chlorhexidine
Intervention Description
mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant surface will be cleaned by copious irrigation with chlorhexidine.
Intervention Type
Procedure
Intervention Name(s)
Er:YAG laser
Intervention Description
mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant surface will be cleaned by copious irrigation with Chlorhexidine. Furthermore, Er:YAG laser treatment will be provided on the implant surface.
Intervention Type
Procedure
Intervention Name(s)
Air Powder
Intervention Description
mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant surface will be cleaned by copious irrigation with Clorhexidine. Furthermore, an Air-Powder treatment will be provided on the implant surface.
Primary Outcome Measure Information:
Title
Bleeding on probing changes.
Description
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.
Time Frame
baseline, 1, 3, 6 months
Secondary Outcome Measure Information:
Title
probing pocket depth changes
Description
changes in probing pocket depth, measured from the mucosal margin to the bottom of the probeable pocket
Time Frame
baseline,1, 3, 6 months
Title
mucosal recession changes
Description
changes in mucosal recession, measured from the mucosal margin to the restoration margin or implant neck
Time Frame
baseline, 1, 3, 6 months
Title
clinical attachment level changes
Description
changes in clinical attachment level, measured from the restoration margin or implant neck to the bottom of the probeable pocket at six aspects per implant (mesio-vestibular, mid-vestibular, disto-vestibular, mesio-oral, mid-oral, and disto-oral.
Time Frame
baseline, 1, 3, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined with:
a PPD ≥ 5 mm and bone loss ≥ 2 mm (compared to crestal bone levels at the time of placement of the reconstruction)
a PPD ≥ 6 mm and bone loss ≥ 3 mm (not compared to crestal bone levels at the time of placement of the reconstruction)
single tooth and bridgework restorations without overhangings
no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment)
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
patients with incapability to perform basal oral hygiene measures due to physical or mental disorders
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
marco clementini, Dr.
Phone
02 26432806
Email
mclementini@me.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo De Sanctis, Prof.
Organizational Affiliation
University Vita Salute San Raffaele
Official's Role
Study Chair
Facility Information:
Facility Name
Università Vita-Salute San Raffaele
City
Milano
ZIP/Postal Code
20100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Clementini
Email
mclementini@me.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Non Surgical Protocol for Treatment of Peri-implantitis
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