search
Back to results

Surgical Protocol for Peri-implantitis Treatment

Primary Purpose

Peri-implantitis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
chlorhexidine
Er:YAG laser
Air-Powder
Sponsored by
Università Vita-Salute San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implantitis focused on measuring peri-implantitis, surgical treatment, Er:Yag laser, Air-flow, chlorhexidine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined with:

    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 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

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

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.

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

clinical attachment level changes
changes in clinical attachment level, measured from CEJ to the tip of the probe
probing pocket depth changes
changes in probing depth probing, measured from gingival margin to te tip of the probe
mucosal recession changes
changes in mucosal recession, measured from CEJ to gingival margin
bone level changes
changes in bone level at mesial and distal aspect, measured on periapical X-ray

Full Information

First Posted
January 9, 2019
Last Updated
November 2, 2020
Sponsor
Università Vita-Salute San Raffaele
search

1. Study Identification

Unique Protocol Identification Number
NCT03801187
Brief Title
Surgical Protocol for Peri-implantitis Treatment
Official Title
Surgical Protocol for Peri-implantitis in Horizontal Defect With Keratinised Tissue Using Er:YAG Laser or an Air-abrasive Device in Addition to Chlorhexidine: 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
December 30, 2020 (Anticipated)
Study Completion Date
December 31, 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-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 peri-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. A treatment protocol that may offer an advantage over traditional mechanical treatment includes the use of laser therapy and air-powder devices. Data have shown that treatments with Er.Yag laser have a bactericidal effect and are safe and effective on implant surfaces. Slightly better clinical results in terms of debridement, probing depth, bleeding on probing and clinical attachment level have been reported by Er:Yag laser treatment compared with traditional non surgical mechanical debridement with titanium curettes and pellet with saline in the surgical treatment of peri-implantitis. The air abrasive method for debridement has also been used on implant surfaces demonstrating no relevant adverse effect. Until now, powders based on sodium bicarbonate and glycine have been used with pressured air/water. Nowadays a less abrasive method involves the use of erythritol powder. The aim of the present randomized controlled clinical trial is to assess the efficacy in improving clinical parameters of two further methods of implant decontamination (er:Yag laser or air-abrasive device) after chemical treatment and chemical cleaning during surgical treatment of peri-implantitis in addition to chlorhexidine in horizontal defects with keratinised tissue around implant surfaces.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implantitis
Keywords
peri-implantitis, surgical treatment, Er:Yag laser, Air-flow, 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
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.
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)
chlorhexidine
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Er:YAG laser
Intervention Description
Er.YAg laser treatment will be provided on the implant surface.
Intervention Type
Procedure
Intervention Name(s)
Air-Powder
Intervention Description
An air powder device will be 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, 3, 6 and 12 months after treatment
Secondary Outcome Measure Information:
Title
clinical attachment level changes
Description
changes in clinical attachment level, measured from CEJ to the tip of the probe
Time Frame
baseline, 3, 6 and 12 months after treatment
Title
probing pocket depth changes
Description
changes in probing depth probing, measured from gingival margin to te tip of the probe
Time Frame
baseline, 3, 6 and 12 months after treatment
Title
mucosal recession changes
Description
changes in mucosal recession, measured from CEJ to gingival margin
Time Frame
baseline, 3, 6 and 12 months after treatment
Title
bone level changes
Description
changes in bone level at mesial and distal aspect, measured on periapical X-ray
Time Frame
baseline and 12 months after treatment

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Clementini
Phone
0226432806
Email
mclementini@me.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo De Sanctis, Prof.
Organizational Affiliation
Università 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

Learn more about this trial

Surgical Protocol for Peri-implantitis Treatment

We'll reach out to this number within 24 hrs