Trials / Completed
CompletedNCT04152668
Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing
Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing: A 12-month Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Knut N. Leknes · Academic / Other
- Sex
- All
- Age
- 20 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Titanium curette. | Implant debridement. |
| PROCEDURE | Ultrasonic | Implant debridement. |
| PROCEDURE | Air-polishing | Implant debridement and polishing. |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2022-03-28
- Completion
- 2022-05-15
- First posted
- 2019-11-05
- Last updated
- 2022-11-14
Locations
2 sites across 1 country: Norway
Source: ClinicalTrials.gov record NCT04152668. Inclusion in this directory is not an endorsement.