Erythritol Air Polishing in Mucositis Treatment

NCT06455306 | Recruiting

• 1 other identifier: Mucositis_Erythritol
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Peri-implant Mucositis

Keywords

peri-implant mucositis; erythritol powder air-polishing; non-surgical treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Probing Pocket Depth

  Baseline, 3 months and 6 months

• Plaque index (PI)

  Baseline, 3 months and 6 months

• Gingival Recession

  Baseline, 3 months and 6 months

• Radiographic bone level

  Baseline, 3 months and 6 months

• Biochemical outcomes

  Baseline, 3 months and 6 months

Study Arms (3)

Test Group Erythritol Monthly Applications

EXPERIMENTAL

Patients will receive monthly applications (months 0, 1, and 2) of treatment with an air-polishing device with erythritol, along with oral hygiene instructions

Procedure: Air-polishing with erythritol at different time points

Control group

NO INTERVENTION

Patients will receive only oral hygiene instructions

Test Group Erythritol Single Application

EXPERIMENTAL

Patients will receive a single application of treatment with an air-polishing device with erythritol, in addition to oral hygiene instructions

Procedure: Single Air-polishing with erythritol

Interventions

Air-polishing with erythritol at different time points PROCEDURE

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

Test Group Erythritol Monthly Applications

Single Air-polishing with erythritol PROCEDURE

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.

Test Group Erythritol Single Application

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating women
• patients unable to understand the treatment protocol and sign informed consent and/or patients younger than 18 years old,
• medical conditions that prevents an oral examination,
• incapability to perform oral hygiene measures due to physical or mental disorders,
• patients with uncontrolled systemic diseases or neoplasms, infection with HIV or hepatitis, cardiovascular disease, blood disorders (e.g. coagulation disorders) and severe osteoporosis,
• 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),
• alcohol or drug addiction
• implants with mobility and/or occlusal overload.

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

University of Coimbra

Coimbra, Portugal

RECRUITING

Related Publications (7)

• 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.

  PMID: 26701919 BACKGROUND

• 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.

  PMID: 29926496 BACKGROUND

• 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.

  PMID: 29926491 BACKGROUND

• 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.

  PMID: 28478213 BACKGROUND

• 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.

  PMID: 37271498 BACKGROUND

• 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.

  PMID: 33210772 BACKGROUND

• 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.

  PMID: 36802083 BACKGROUND

MeSH Terms

Interventions

Erythritol

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Orlando Martins

  Visiting Assistant Professor

  STUDY DIRECTOR

Central Study Contacts

Orlando Martins

CONTACT

917298190; orlmm@yahoo.com

Diogo Banaco

CONTACT

918724423; diogobanaco@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Assistant Professor

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: June 12, 2024
• Study Start: March 18, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

PT (1)