Surgical Protocol for Peri-Implantitis Treatment-3

November 2, 2020 updated by: Marco Clementini, Università Vita-Salute San Raffaele

Surgical Protocol for Peri-implantitis in Horizontal Defect in Absence of Keratinised Tissue Using Chemical Decontamination With Chlorhexidine and a CTG: 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

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. Another problem in maintaining implant health concerns the presence or absence of keratinised tissue around implant: if present, it seams to help the patient to maintain an optimal level of oral hygiene around implant and therefore the implant survival itself.

The aim of the present randomized controlled clinical trial is to assess the influence of keratinised tissue around implant in improving clinical parameters. In particular, implant surface will be decontaminated mechanically with titanium curettes and chemically using chlorhexidine; after this a CTG around tissue implant will be randomized

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: De Sanctis

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Connective Tissue Graft
CTG will be positioned in the buccal aspect of the peri-implant tissue
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.
CTG will be positioned in the buccal aspect of the peri-implant tissue
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.
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
Time Frame: baseline, 3, 6 and 12 months after treatment
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
Time Frame: baseline, 3, 6 and 12 months after treatment
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
Time Frame: baseline, 3, 6 and 12 months after treatment
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
Time Frame: baseline, 3, 6 and 12 months after treatment
changes in mucosal recession, measured from CEJ to gingival margin
baseline, 3, 6 and 12 months after treatment
bone level changes
Time Frame: baseline and 12 months after treatment
changes in bone level at mesial and distal aspect, measured on periapical X-ray
baseline and 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

May 7, 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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