Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing

November 8, 2022 updated by: Knut N. Leknes

Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing: A 12-month Randomized Controlled Trial

Erythritol is a natural sugar alcohol (a four-carbon polyol) produced by the reduction of erythrose. It is considered safe as food additive and has many of the functional properties that are important for subgingival debridement. Current evidence includes no prospective studies comparing the outcomes of a low abrasive erythritol air-polishing as an adjunctive therapy to conventional titanium and ultrasonic debridement of patients in a maintenance program with peri-implantitis. Thus, the main purpose of this randomized, single-masked controlled trial (RCT) is to assess whether low abrasive erythritol air-polishing has an adjunct effect to conventional non-surgical treatment of peri-implantitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This RCT will enroll subjects among patients in need for non-surgical treatment of peri-implantitis at a private dental clinic in Stavanger, Norway. Forty patients diagnosed with peri-implantitis on at least one implant will be randomly allocated by tossing a coin into test or control group. Patients with cement-retained and screw-retained supraconstructions will be included.

Treatment of peri-implantitis will be performed by one operator (AS) at baseline, 3-, 6-, 9- and 12-month follow-up visits. Local anesthesia will be used when needed. In the test group, implants will be treated with titanium curette, ultrasonic device and a specially designed nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit.

In the control group, implant with peri-implantitis will be debrided with titanium curette and ultrasonic device only. Test and control debridement will be performed without time limit. The treatment will continue until the operator is judging the implant surface to be free for supra- and subgingival deposits.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Norway
      • Bergen, Norway, 5232
        • Knut N. Leknes
      • Bergen, Norway, N-5009 Bergen
        • Knut N. Leknes

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

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects aged 20 - 85 years who have received one or more dental implant(s) being in successful function for more than 12 months and restored with an optimal supraconstruction

  • Diagnosed with peri-implantitis based on the following criteria:

    • Bleeding and/or suppuration upon gentle probing
    • Increased probing depths (PD) compared with previous examinations or PD of ≥ 4 mm in at least one site around the implant
    • Crestal bone level (CBL) loss ≥2 mm compared with baseline registration

Exclusion Criteria:

  • Surgical treatment of peri-implantitis the last 6 months
  • Supportive periodontal therapy within 3 months
  • Use of systemic antibiotic within 6 months
  • A history of non-compliant behavior
  • Inflammation around implant without evidence of bone loss
  • Periapical peri-implantitis
  • Subjects with implant fracture, ceramic implants, or detectable subgingival cement
  • Any current medical condition affecting the use of the abrasive air-polishing device.
  • Subjects with diabetes mellitus, cancer, HIV/aids, acute infections, liver or kidney dysfunction/failure,
  • Current pregnancy or breastfeeding

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Titanium curette and ultrasonic.
Control implants will be debrided with titanium curette and ultrasonic device without time limit.
Procedure: Titanium curette.
Implant debridement.
Procedure: Ultrasonic
Implant debridement.
Other Names:
  • Ultrasonic device
Experimental: Titanium curette, ultrasonic and air-polishing.
Test implants will be treated with titanium curette, ultrasonic device and a specially designed nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit also without time limit.
Procedure: Titanium curette.
Implant debridement.
Procedure: Ultrasonic
Implant debridement.
Other Names:
  • Ultrasonic device
Procedure: Air-polishing
Implant debridement and polishing.
Other Names:
  • Air-polishing device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in probing depth (PD)
Time Frame: 12 moths
PD as the distance in mm from the implant mucosal margin to the probable base of the pocket at six sites;
12 moths
Crestal bone level (CBL)
Time Frame: 12 months
Intraoral digitalized radiographs will be taken with customized Eggen-holder and long cone, parallel technique to assess CBL. The distance from implant platform to the mesial and distal bone levels will be measured by using the software program DIGORA (Soredex, Helsinki).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing (BoP)
Time Frame: 12 months
BoP as the presence of bleeding after gentle probing (Renvert et al. 2017).
12 months
Gingival crevicular fluid (GCF)
Time Frame: 12 months
Sample sites will be isolated with cottons rolls, carefully cleaned for supragingival plaque and air-dried. A perio paper strip will then be gently placed one to two mm into the entrance of the pocket and left in place for 30 seconds.
12 months
Visual analogue scale (VAS)
Time Frame: 12 months
The scorings will be performed following completion of the debridement at baseline and at 6 and 12 months with 0 = "no pain" and 100 = "worst pain I can imagine".
12 months

Collaborators and Investigators

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

Sponsor

Knut N. Leknes

Investigators

  • Principal Investigator: Knut N. Leknes, Professor, Department of Clinical Dentistry - Periodontics, University of Bergen, NORWAY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Citations to publications related to the protocol: Background and Material and Methods.

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)

December 1, 2021

Primary Completion (Actual)

March 28, 2022

Study Completion (Actual)

May 15, 2022

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

November 3, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UiB, IKO 2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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