Surgical Protocol for Peri-implantitis Treatment-2

Surgical Protocol for Peri-implantitis in Vertical Defect With Keratinised Tissue Using Er:YAG Laser or an Air-abrasive Device in Addition to Chlorhexidine: a Randomized Clinical Trial

Peri-implant diseases are common post-restorative complications in implant rehabilitations and they occur with an incidence of 12-43%.

Based on the available data in literature, the surgical therapy for peri-implantitis is effective in disease resolution. Surgical access to peri-implant lesions facilitates the removal of all granulation tissue from the defect area as well as debridement and decontamination of the exposed implant surface defect area.

Different techniques have been used for implant surface decontamination during peri-implant surgery, including mechanical, chemical and laser treatments.

Study Overview

• Status: Unknown
• Conditions: Peri-Implantitis
• Intervention / Treatment: Procedure: chlorhexidine

Detailed Description

Peri-implantitis are defined as inflammatory diseases caused by bacterial biofilm around implant surface characterized by bleeding on probing, probing depth and eventually bone loss; if not successfully treated they may lead to implant loss. Based on the available parameters that have been reported in literature non surgical therapy doesn't seem to be effective on peri-implantitis. Therefore it is recommended to consider advanced therapies such as surgical interventions when non surgical peri-implant therapy fails to achieve significant improvements in clinical parameters.

Numerous approaches have been used for implant surface decontamination during per-implant surgery, including mechanical, chemical and laser treatments.

Conventional mechanical means don't seem to be effective on peri-implant diseases. In addition, the rough implant surface is a retentive factor for bacterial colonization and therefore makes implant surface difficult to debride.

A treatment protocol that may offer an advantage over traditional mechanical treatment includes the use of laser therapy and air-powder devices. Data have shown that treatments with Er.Yag laser have a bactericidal effect and are safe and effective on implant surfaces. Slightly better clinical results in terms of debridement, probing depth, bleeding on probing and clinical attachment level have been reported by Er:Yag laser treatment compared with traditional non surgical mechanical debridement with titanium curettes and pellet with saline in the surgical treatment of peri-implantitis.

The air abrasive method for debridement has also been used on implant surfaces demonstrating no relevant adverse effect. Until now, powders based on sodium bicarbonate and glycine have been used with pressured air/water. Nowadays a less abrasive method involves the use of erythritol powder.

The aim of the present randomized controlled clinical trial is to assess the efficacy in improving clinical parameters of two further methods of implant decontamination (er:Yag laser or air-abrasive device) after chemical treatment and chemical cleaning during surgical treatment of peri-implantitis in addition to chlorhexidine in vertical defects with keratinised tissue around implant surfaces. Furthermore the bone defect will be filled with bio-material.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20100
    • Recruiting
    • Università Vita-Salute San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined with:

  1. PPD ≥ 5 mm and bone loss ≥ 2 mm (compared to crestal bone levels at the time of placement of the reconstruction)
  2. PPD ≥6 and bone loss ≥3 (not compared to crestal bone levels at the time of placement of the reconstruction)
• single tooth and bridgework restorations without overhangs
• no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment),
• treated chronic periodontitis and proper periodontal maintenance care FMPS < 20%
• non-smoker or light smoking status in smokers (<10 cigarettes per day) 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Chlorhexidine; Access flap will be raised to gain access to the implant surface. Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in Chlorhexidine.	Procedure: chlorhexidine; Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine.
Experimental: Er:YAG laser; Er: Yag laser treatment will be provided on the implant surface.	Procedure: chlorhexidine; Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine.
Active Comparator: Air Powder; An Air-Powder treatment will be provided on the implant surface	Procedure: chlorhexidine; Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, 3, 6 and 12 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical attachment level changes	changes in clinical attachment level, measured from CEJ to the tip of the probe	baseline, 3, 6 and 12 months after treatment
probing pocket depth changes	changes in probing depth probing, measured from gingival margin to te tip of the probe	baseline, 3, 6 and 12 months after treatment
mucosal recession changes	changes in mucosal recession, measured from CEJ to gingival margin	baseline, 3, 6 and 12 months after treatment
bone level changes	changes in bone level at mesial and distal aspect, measured on periapical X-ray	baseline and 12 months after treatment

Collaborators and Investigators

• Sponsor: Università Vita-Salute San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2018
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: chlorhexidine; surgical treatment; peri-implantitis; Er:Yag laser; Air-flow
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: peri-implant surgical-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No