Non Surgical Protocol for Treatment of Mucositis Using an Er:YAG Laser or an Air-abrasive Device: a Randomized Clinical Trial

Non Surgical Protocol for Treatment of Mucositis

Sponsors

Lead sponsor: Università Vita-Salute San Raffaele

Source Università Vita-Salute San Raffaele
Brief Summary

Peri-implant mucositis 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 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 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-implant mucositis.

Detailed Description

Peri-implant mucositis, defined as an inflammatory lesion in the surrounding peri-implant tissues without 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-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 curette 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 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 mucositis.

Overall Status Recruiting
Start Date July 2, 2018
Completion Date December 30, 2021
Primary Completion Date December 30, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Bleeding on probing changes baseline, 1, 3, 6 months
Secondary Outcome
Measure Time Frame
probing pocket depth changes baseline, 1, 3, 6 months
mucosal recession changes baseline, 1, 3, 6 months
clinical attachment level changes baseline, 1, 3, 6 months
Enrollment 45
Condition
Intervention

Intervention type: Procedure

Intervention name: Chlorhexidine

Description: mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant abutment surface will be cleaned by copious irrigation with chlorhexidine

Intervention type: Procedure

Intervention name: Er:YAG laser

Description: mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant abutment surface will be cleaned by copious irrigation with chlorhexidine

Arm group label: Er:YAG laser

Intervention type: Procedure

Intervention name: Air Powder

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/abutment surface.

Arm group label: Air Powder

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 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

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Massimo De Sanctis Study Chair Università Vita-Salute San Raffaele
Overall Contact

Last name: marco clementini

Phone: 02 26432806

Email: [email protected]

Location
facility status contact Università Vita-Salute San Raffaele Marco Clementini 02 26432806 [email protected]
Location Countries

Italy

Verification Date

June 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Università Vita-Salute San Raffaele

Investigator full name: Marco Clementini

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Chlorhexidine

Arm group type: Sham Comparator

Description: mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant/abutment surface will be cleaned by copious irrigation with Chlorhexidine

Arm group label: Er:YAG laser

Arm group type: Experimental

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

Arm group label: Air Powder

Arm group type: Active Comparator

Description: an Air-Powder treatment will be provided on the implant/abutment surface.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov