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

NCT ID: NCT04152668

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-05-15

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.

Conditions

Peri-Implantitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Titanium curette and ultrasonic.

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

Group Type: ACTIVE_COMPARATOR

Titanium curette.

Intervention Type: PROCEDURE

Implant debridement.

Ultrasonic

Intervention Type: PROCEDURE

Implant debridement.

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.

Group Type: EXPERIMENTAL

Titanium curette.

Intervention Type: PROCEDURE

Implant debridement.

Ultrasonic

Intervention Type: PROCEDURE

Implant debridement.

Air-polishing

Intervention Type: PROCEDURE

Implant debridement and polishing.

Interventions

Titanium curette.

Implant debridement.

Intervention Type: PROCEDURE

Ultrasonic

Implant debridement.

Intervention Type: PROCEDURE

Air-polishing

Implant debridement and polishing.

Intervention Type: PROCEDURE

Other Intervention Names

Ultrasonic device; Air-polishing device

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Knut N. Leknes

OTHER

Sponsor Role: lead

Responsible Party

Knut N. Leknes

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Knut N. Leknes, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Knut N. Leknes

Bergen, , Norway

Knut N. Leknes

Bergen, , Norway

Countries

Norway

References

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

Reference Type: 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.

Reference Type: DERIVED

PMID: 37095488 (View on PubMed)

Other Identifiers

UiB, IKO 2019

Identifier Type: -

Identifier Source: org_study_id