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Non Surgical Protocol for Treatment of Mucositis

Primary Purpose

Peri-implant Mucositis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Mechanical debridement with curettes
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-implant Mucositis focused on measuring peri-implant mucositis, non surgical therapy, laser, air powder

Eligibility Criteria

18 Years - 100 Years (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 without progressive radiographic bone loss (compared to crestal bone levels at the time of placement of the reconstruction)or <3mm bone loss
  • single tooth and bridgework restorations without overhanging
  • 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 Raffaele

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Active Comparator

Arm Label

Mechanical debridement with curettes

Er:YAG laser

Air Powder

Arm Description

mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments

Er:YAG laser treatment will be provided on the implant/abutment surface.

an Air-Powder treatment will be provided on the implant/abutment 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 probable 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 probable pocket at six aspects per implant (mesio-vestibular, mid-vestibular, disto-vestibular, mesio-oral, mid-oral, and disto-oral.
complete disease resolution (percentage)
At the implant level, the level of disease resolution was defined as complete when BoP was = 0 out of six sites per implant

Full Information

First Posted
May 14, 2019
Last Updated
February 28, 2023
Sponsor
Università Vita-Salute San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT03951636
Brief Title
Non Surgical Protocol for Treatment of Mucositis
Official Title
Non Surgical Protocol for Treatment of Mucositis Using an Er:YAG Laser or an Air-abrasive Device: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 2, 2019 (Actual)
Primary Completion Date
January 16, 2022 (Actual)
Study Completion Date
July 27, 2022 (Actual)

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 mucositis is an important disease entity as a result of its high prevalence and the lack of a standard mode of therapy. Non-surgical therapy of peri-implant mucositis 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 partial resolution and presence of pocket at follow-up visits) 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 cleaning during non surgical treatment of peri-implant mucositis.
Detailed Description
Peri-implant mucositis, defined as an inflammatory lesion of the surrounding peri-implant tissues without loss of supporting bone, is an important disease entity as a result of its high prevalence and the lack of a standard mode of therapy. Although the current epidemiological data are limited, peri-implant mucositis affects 43% of the subjects. Numerous approaches have been used for implant surface decontamination, 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 debridement, 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 curettes and chlorhexidine. The air abrasive method for the removal of bacterial plaque on tooth surfaces has also been used in the treatment of mucositis, 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 aminoacid 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 cleaning during non surgical treatment of mucositis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis
Keywords
peri-implant mucositis, non surgical therapy, laser, air powder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mechanical debridement with curettes
Arm Type
Sham Comparator
Arm Description
mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments
Arm Title
Er:YAG laser
Arm Type
Experimental
Arm Description
Er:YAG laser treatment will be provided on the implant/abutment surface.
Arm Title
Air Powder
Arm Type
Active Comparator
Arm Description
an Air-Powder treatment will be provided on the implant/abutment surface.
Intervention Type
Procedure
Intervention Name(s)
Mechanical debridement with curettes
Intervention Description
mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments
Intervention Type
Procedure
Intervention Name(s)
Er:YAG laser
Intervention Description
mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments. Furthermore, an Er:YAG laser will be used for the implant surface decontamination.
Intervention Type
Procedure
Intervention Name(s)
Air Powder
Intervention Description
mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments. Furthermore, an Air-Powder treatment will be provided on the implant/abutment 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 probable 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 probable 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
Title
complete disease resolution (percentage)
Description
At the implant level, the level of disease resolution was defined as complete when BoP was = 0 out of six sites per implant
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 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 without progressive radiographic bone loss (compared to crestal bone levels at the time of placement of the reconstruction)or <3mm bone level 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo De Sanctis
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

12. IPD Sharing Statement

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Non Surgical Protocol for Treatment of Mucositis

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