Non Surgical Protocol for Treatment of Peri-implantitis

NCT03451981 | Completed DMC

• 1 other identifier: peri-implant non surgical-1
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-implantitis 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 disease, especially when bone loss is not high, 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 cleaning during non surgical treatment of peri-implantitis.

Conditions

Peri-Implantitis

Keywords

non surgical therapy; laser; air powder

Outcome Measures

Primary Outcomes (1)

• probing pocket depth changes

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

  baseline, 1, 3, 6 months

Secondary Outcomes (2)

• Bleeding on probing changes

  baseline,1, 3, 6 months

• endpoint of therapy

  1,3,6 months

Study Arms (3)

Mechanical instrumentation with curettes

SHAM COMPARATOR

mechanical instrumentation: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments (titanium curettes) and the implant surface will be cleaned.

Procedure: mechanical instrumentation

Er:YAG laser

EXPERIMENTAL

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

Procedure: mechanical instrumentation; Procedure: Er:YAG laser

Air Powder

ACTIVE COMPARATOR

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

Procedure: mechanical instrumentation; Procedure: Air Powder

Interventions

Er:YAG laser PROCEDURE

mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments (titanium curettes) and the implant surface will be cleaned. Furthermore, Er:YAG laser treatment will be provided on the implant surface.

Er:YAG laser

Air Powder PROCEDURE

mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments (titanium curettes) and the implant surface will be cleaned. Furthermore, an Air-Powder treatment will be provided on the implant surface.

Air Powder

mechanical instrumentation PROCEDURE

mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments (titanium curettes) and the implant surface will be cleaned

Also known as: titanium curettes

Air Powder; Er:YAG laser; Mechanical instrumentation with curettes

Eligibility Criteria

• Age: 18 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 with:
• a PPD ≥ 5 mm and bone loss \> 2 mm (compared to crestal bone levels at the time of placement of the reconstruction)
• a PPD ≥ 6 mm and bone loss ≥ 3 mm (not compared to crestal bone levels at the time of placement of the reconstruction)
• 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, Milano, 20100, Italy

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Massimo De Sanctis, Prof.

  University 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: February 20, 2018
• First Posted: March 2, 2018
• Study Start: December 2, 2018
• Primary Completion: October 6, 2021
• Study Completion: October 6, 2021
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

IT (1)