Non Surgical Protocol for Treatment of Mucositis

NCT03951636 | Completed DMC

• 1 other identifier: mucositis non surgical
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implant Mucositis

Keywords

peri-implant mucositis; non surgical therapy; laser; air powder

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, 1, 3, 6 months

Secondary Outcomes (4)

• 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

• complete disease resolution (percentage)

  6 months

Study Arms (3)

Mechanical debridement with curettes

SHAM COMPARATOR

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

Procedure: Mechanical debridement with curettes

Er:YAG laser

EXPERIMENTAL

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

Procedure: Er:YAG laser

Air Powder

ACTIVE COMPARATOR

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

Procedure: Air Powder

Interventions

Mechanical debridement with curettes PROCEDURE

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

Mechanical debridement with curettes

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.

Er:YAG laser

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.

Air Powder

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

Università Vita-Salute San Raffaele

Milan, 20100, Italy

Location

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Massimo De Sanctis

  Università Vita-Salute San Raffaele

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 15, 2019
• Study Start: July 2, 2019
• Primary Completion: January 16, 2022
• Study Completion: July 27, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-02

Locations

IT (1)