NCT06455306

Erythritol Air Polishing in Mucositis Treatment

Erythritol Air Polishing in Mucositis Treatment: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Coimbra · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study aimed to evaluate the effectiveness of air polishing systems compared to the exclusive use of oral hygiene instruction in the treatment of peri-implant mucositis

Detailed description

The study will include individuals aged 18 to 80 who have at least one implant and exhibit peri-implant mucositis, as defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Participants will be selected from those attending Periodontology, Oral Surgery, and Oral Medicine consultations at the dental medicine clinic of the University Hospital Center of the University of Coimbra (CHUC). After confirming the inclusion and exclusion criteria, patients will be invited to participate in the study, and if they agree to participate, they will sign an Informed Consent Form. The study is conducted as a parallel-design clinical trial, and each participant will be randomly allocated to one of three groups: Test 1 (T1), Test 2 (T2), or Control (C). Group T1 will consist of patients receiving a single application of treatment with an air-polishing device with erythritol, in addition to oral hygiene instructions (OHI). Group T2 will consist of patients receiving monthly applications (months 0, 1, and 2) of treatment with an air-polishing device with erythritol, along with OHI. Group C will consist of patients receiving only OHI. The treatments and OHI will be performed by an experienced periodontist who is different from the one collecting clinical, radiographic, and PICF data. The clinical examination that will be performed at baseline, 3 and 6 months after baseline includes a periodontal chart at six sites per each tooth and/or included implant. In addition, collection of peri-implant crevicular fluid (PICF) will be done to evaluate a panel of biomarkers. Samples will be collected from two locations around each implant, isolated with cotton rolls and dried. Using the filter paper technique, a strip of standard length and height filter paper (Periopaper, Pro Flow, New York, USA) will be inserted into the peri-implant sulcus and left in place for 30 seconds. Samples will be placed in plastic centrifuge tubes and kept on ice until they are frozen (-80°C) in the laboratory of the Clinical Pathology Service at CHUC. Sampling should be performed prior to peri-implant clinical examination and after gentle removal of supra-gingival plaque. Biochemical analysis will be conducted using Luminex to evaluate the inflammatory pattern through the use of a panel of biomarkers. Schedule of appointments by Group: * Group T1: Month 0 appointment (collection of clinical data, X-rays, and Peri-implant crevicular fluid (PICF); OHI + treatment); Month 3 appointment (collection of clinical data and PICF); Month 6 appointment (collection of clinical data, X-rays, and PICF). * Group T2: Month 0 appointment (collection of clinical data, X-rays, and PICF; OHI + treatment); Month 1 appointment (OHI + treatment); Month 2 appointment (OHI + treatment); Month 3 appointment (collection of clinical data and PICF); Month 6 appointment (collection of clinical data, X-rays, and PICF). * Group C: Month 0 appointment (collection of clinical data, X-rays, and PICF; OHI); Month 3 appointment (collection of clinical data and PICF); Month 6 appointment (collection of clinical data, X-rays, and PICF).

Conditions

• Peri-implant Mucositis

Interventions

Type	Name	Description
PROCEDURE	Air-polishing with erythritol at different time points	The air-polishing device will be inserted into each site of the peri-implant pocket at an angle ranging from 60 to 90 degrees, and each surface will be debrided for 5 seconds using erythritol powder (AIRFLOW Powder PERIO; EMS). In this group this procedure will be done ate baseline, 1 month and 2 months
PROCEDURE	Single Air-polishing with erythritol	The air-polishing device will be inserted into each site of the peri-implant pocket at an angle ranging from 60 to 90 degrees, and each surface will be debrided for 5 seconds using erythritol powder (AIRFLOW Powder PERIO; EMS). In this group this procedure will be done ate baseline only.

Timeline

• Start date: 2024-03-18
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-06-12
• Last updated: 2024-06-12

Locations

1 site across 1 country: Portugal