search
Back to results

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

Primary Purpose

Peri-Implantitis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Titanium curette.
Ultrasonic
Air-polishing
Sponsored by
Knut N. Leknes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring Peri-implantitis, Air-polishing, Erythritol

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Knut N. Leknes
  • Knut N. Leknes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Titanium curette and ultrasonic.

Titanium curette, ultrasonic and air-polishing.

Arm Description

Control implants will be debrided with titanium curette and ultrasonic device without time limit.

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.

Outcomes

Primary Outcome Measures

Changes in probing depth (PD)
PD as the distance in mm from the implant mucosal margin to the probable base of the pocket at six sites;
Crestal bone level (CBL)
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).

Secondary Outcome Measures

Bleeding on probing (BoP)
BoP as the presence of bleeding after gentle probing (Renvert et al. 2017).
Gingival crevicular fluid (GCF)
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.
Visual analogue scale (VAS)
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".

Full Information

First Posted
October 30, 2019
Last Updated
November 8, 2022
Sponsor
Knut N. Leknes
search

1. Study Identification

Unique Protocol Identification Number
NCT04152668
Brief Title
Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing
Official Title
Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing: A 12-month Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Knut N. Leknes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
Peri-implantitis, Air-polishing, Erythritol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, single-masked controlled trial (RCT)
Masking
InvestigatorOutcomes Assessor
Masking Description
Forty patients diagnosed with peri-implantitis on at least one implant will be randomly allocated by tossing a coin into test or control group. Two different operators will participate in the study (ML and AS). ML masked to the treatment assignment, will collect the data, and AS will perform the treatment.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Titanium curette and ultrasonic.
Arm Type
Active Comparator
Arm Description
Control implants will be debrided with titanium curette and ultrasonic device without time limit.
Arm Title
Titanium curette, ultrasonic and air-polishing.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Titanium curette.
Intervention Description
Implant debridement.
Intervention Type
Procedure
Intervention Name(s)
Ultrasonic
Other Intervention Name(s)
Ultrasonic device
Intervention Description
Implant debridement.
Intervention Type
Procedure
Intervention Name(s)
Air-polishing
Other Intervention Name(s)
Air-polishing device
Intervention Description
Implant debridement and polishing.
Primary Outcome Measure Information:
Title
Changes in probing depth (PD)
Description
PD as the distance in mm from the implant mucosal margin to the probable base of the pocket at six sites;
Time Frame
12 moths
Title
Crestal bone level (CBL)
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Bleeding on probing (BoP)
Description
BoP as the presence of bleeding after gentle probing (Renvert et al. 2017).
Time Frame
12 months
Title
Gingival crevicular fluid (GCF)
Description
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.
Time Frame
12 months
Title
Visual analogue scale (VAS)
Description
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".
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut N. Leknes, Professor
Organizational Affiliation
Department of Clinical Dentistry - Periodontics, University of Bergen, NORWAY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Knut N. Leknes
City
Bergen
ZIP/Postal Code
5232
Country
Norway
Facility Name
Knut N. Leknes
City
Bergen
ZIP/Postal Code
N-5009 Bergen
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Citations to publications related to the protocol: Background and Material and Methods.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs