Clinical trial NCT04152668: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Keywords: Peri-implantitis
Air-polishing
Erythritol
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-masked controlled trial (RCT)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in probing depth (PD)
timeFrame: 12 moths
measure: Crestal bone level (CBL)
timeFrame: 12 months
Secondary outcomes:
measure: Bleeding on probing (BoP)
timeFrame: 12 months
measure: Gingival crevicular fluid (GCF)
timeFrame: 12 months
measure: Visual analogue scale (VAS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Knut N. Leknes
city: Bergen
country: Norway
facility: Knut N. Leknes
Study officials:
affiliation: Department of Clinical Dentistry - Periodontics, University of Bergen, NORWAY
name: Knut N. Leknes, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Citations to publications related to the protocol: Background and Material and Methods.