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Completed

NCT Number: NCT03951636

Non Surgical Protocol for Treatment of Mucositis

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università Vita-Salute San Raffaele

Milan, 20100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical debridement with curettes

Procedure

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

Er:YAG laser

Procedure

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.

Air Powder

Procedure

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 outcomes

  1. Bleeding on probing changes

    Time frame: baseline, 1, 3, 6 months

    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 outcomes

  1. probing pocket depth changes

    Time frame: baseline, 1, 3, 6 months

    changes in probing pocket depth, measured from the mucosal margin to the bottom of the probable pocket

  2. mucosal recession changes

    Time frame: baseline, 1, 3, 6 months

    changes in mucosal recession, measured from the mucosal margin to the restoration margin or implant neck

  3. clinical attachment level changes

    Time frame: baseline, 1, 3, 6 months

    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.

  4. complete disease resolution (percentage)

    Time frame: 6 months

    At the implant level, the level of disease resolution was defined as complete when BoP was = 0 out of six sites per implant

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 15, 2019
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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