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

NCT04152668 | Completed

• 1 other identifier: UiB, IKO 2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Peri-Implantitis

Keywords

Peri-implantitis; Air-polishing; Erythritol

Outcome Measures

Primary Outcomes (2)

• 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;

  12 moths

• 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).

  12 months

Secondary Outcomes (3)

• Bleeding on probing (BoP)

  12 months

• Gingival crevicular fluid (GCF)

  12 months

• Visual analogue scale (VAS)

  12 months

Study Arms (2)

Titanium curette and ultrasonic.

ACTIVE COMPARATOR

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

Procedure: Titanium curette.; Procedure: Ultrasonic

Titanium curette, ultrasonic and air-polishing.

EXPERIMENTAL

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.; Procedure: Ultrasonic; Procedure: Air-polishing

Interventions

Titanium curette. PROCEDURE

Implant debridement.

Titanium curette and ultrasonic.; Titanium curette, ultrasonic and air-polishing.

Ultrasonic PROCEDURE

Implant debridement.

Also known as: Ultrasonic device

Titanium curette and ultrasonic.; Titanium curette, ultrasonic and air-polishing.

Air-polishing PROCEDURE

Implant debridement and polishing.

Also known as: Air-polishing device

Titanium curette, ultrasonic and air-polishing.

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Knut N. Leknes: lead

Study Sites (2)

Knut N. Leknes

Bergen, 5232, Norway

Location

Knut N. Leknes

Bergen, N-5009 Bergen, Norway

Location

Related Publications (2)

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

  BACKGROUND

• Selimovic A, Bunaes DF, Lie SA, Lobekk MA, Leknes KN. Non-surgical treatment of peri-implantitis with and without erythritol air-polishing a 12-month randomized controlled trial. BMC Oral Health. 2023 Apr 24;23(1):240. doi: 10.1186/s12903-023-02973-5.

  PMID: 37095488 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Knut N. Leknes, Professor

  Department of Clinical Dentistry - Periodontics, University of Bergen, NORWAY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, single-masked controlled trial (RCT)

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 5, 2019
• Study Start: December 1, 2021
• Primary Completion: March 28, 2022
• Study Completion: May 15, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)