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

Knut N. Leknes

Status: Completed

Conditions: Peri-Implantitis

Treatments: Procedure: Titanium curette.; Procedure: Air-polishing; Procedure: Ultrasonic

Study type: Interventional

Funder types: Other

Identifiers

NCT04152668

UiB, IKO 2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Titanium curette and ultrasonic.

Active Comparator group

Description:

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

Treatment:

Procedure: Ultrasonic

Procedure: Titanium curette.

Titanium curette, ultrasonic and air-polishing.

Experimental group

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.

Treatment:

Procedure: Ultrasonic

Procedure: Air-polishing

Procedure: Titanium curette.