Skip to main content
OpenTrials
Completed

NCT Number: NCT04152668

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Knut N. Leknes, Bergen, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Titanium curette.

Procedure

Implant debridement.

ultrasonic

Procedure

Implant debridement.

Other names: Ultrasonic device

Air-polishing

Procedure

Implant debridement and polishing.

Other names: Air-polishing device

Primary outcomes

  1. 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;

  2. 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).

Secondary outcomes

  1. Bleeding on probing (BoP)

    Time frame: 12 months

    BoP as the presence of bleeding after gentle probing (Renvert et al. 2017).

  2. 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.

  3. 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".

Sponsors and collaborators

Lead sponsor

Knut N. Leknes

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 5, 2019
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.