Erythritol Air Polishing in Mucositis Treatment

Peri-implant Mucositis Clinical Trial

Official title:

Erythritol Air Polishing in Mucositis Treatment: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06455306
• Other study ID #: Mucositis_Erythritol
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: University of Coimbra
• Contact: Orlando Martins
• Phone: 917298190
• Email: orlmm[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adults with at least one implant in function for a minimum of one year affected by peri-implant mucositis.

Exclusion Criteria:

1. Pregnant or lactating women

2. patients unable to understand the treatment protocol and sign informed consent and/or patients younger than 18 years old,

3. medical conditions that prevents an oral examination,

4. incapability to perform oral hygiene measures due to physical or mental disorders,

5. patients with uncontrolled systemic diseases or neoplasms, infection with HIV or hepatitis, cardiovascular disease, blood disorders (e.g. coagulation disorders) and severe osteoporosis,

6. patients who have received systemic antibiotics, corticosteroids, or immunosuppressive therapy within 3 months before periodontal evaluation (baseline), as well as those who chronically use nonsteroidal anti-inflammatory drugs, require antibiotic coverage for dental procedures, and those who are undergoing chronic treatment with medications known to affect periodontal health (such as phenytoin or cyclosporine),

7. alcohol or drug addiction

8. implants with mobility and/or occlusal overload.

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

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
• 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.

Locations

Country	Name	City	State
Portugal	University of Coimbra	Coimbra

Sponsors (1)

Lead Sponsor	Collaborator
University of Coimbra

Country where clinical trial is conducted

Portugal, 

References & Publications (7)

Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957. — View Citation

Derks J, Schaller D, Hakansson J, Wennstrom JL, Tomasi C, Berglundh T. Effectiveness of Implant Therapy Analyzed in a Swedish Population: Prevalence of Peri-implantitis. J Dent Res. 2016 Jan;95(1):43-9. doi: 10.1177/0022034515608832. — View Citation

Herrera D, Berglundh T, Schwarz F, Chapple I, Jepsen S, Sculean A, Kebschull M, Papapanou PN, Tonetti MS, Sanz M; EFP workshop participants and methodological consultant. Prevention and treatment of peri-implant diseases-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2023 Jun;50 Suppl 26:4-76. doi: 10.1111/jcpe.13823. Epub 2023 Jun 4. — View Citation

Lee CT, Huang YW, Zhu L, Weltman R. Prevalences of peri-implantitis and peri-implant mucositis: systematic review and meta-analysis. J Dent. 2017 Jul;62:1-12. doi: 10.1016/j.jdent.2017.04.011. Epub 2017 May 3. — View Citation

Renvert S, Persson GR, Pirih FQ, Camargo PM. Peri-implant health, peri-implant mucositis, and peri-implantitis: Case definitions and diagnostic considerations. J Clin Periodontol. 2018 Jun;45 Suppl 20:S278-S285. doi: 10.1111/jcpe.12956. — View Citation

Romandini M, Lima C, Pedrinaci I, Araoz A, Soldini MC, Sanz M. Prevalence and risk/protective indicators of peri-implant diseases: A university-representative cross-sectional study. Clin Oral Implants Res. 2021 Jan;32(1):112-122. doi: 10.1111/clr.13684. Epub 2020 Dec 29. — View Citation

Verket A, Koldsland OC, Bunaes D, Lie SA, Romandini M. Non-surgical therapy of peri-implant mucositis-Mechanical/physical approaches: A systematic review. J Clin Periodontol. 2023 Jun;50 Suppl 26:135-145. doi: 10.1111/jcpe.13789. Epub 2023 Feb 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Bleeding on Probing compared to baseline	Bleeding on Probing (BoP) will be evaluated according to the modified bleeding index (0-no BoP; 1- punctiform drop of bleed; 2- confluent red continuous line formed through the sulcus; 3-heavy/profuse), for each site	Baseline, 3 months and 6 months
Secondary	Probing Pocket Depth	Measured in mm from the mucosal margin to most apical point of the pocket	Baseline, 3 months and 6 months
Secondary	Plaque index (PI)	assessed dichotomously as the presence or absence of plaque along the mucosal/gingival margin	Baseline, 3 months and 6 months
Secondary	Gingival Recession	Distance, measured in mm from the cementoenamel junction to the gingival margin	Baseline, 3 months and 6 months
Secondary	Radiographic bone level	calculated as the difference between the marginal bone levels assessed at follow-up visits and the ones assessed in the baseline	Baseline, 3 months and 6 months
Secondary	Biochemical outcomes	Peri-implant crevicular fluid (PICF) analysis: a collection of PICF samples will be done to evaluate a panel of biomarkers (IL-4, IL-6, IL-10, IL-1B)	Baseline, 3 months and 6 months
Secondary	Complete Disease Resolution	Total Absence of bleeding on probing and deep probing pocket depths on the implant site	3 months and 6 months
Secondary	Keratinized Tissue	Measure in mm in the vestibular site	Baseline, 3 months and 6 months
Secondary	Prosthetic Margin Level	Level of the prosthetic implant connection regarding the gingival margin	Baseline, 3 months and 6 months