Erythritol Air Polishing in Mucositis Treatment

June 6, 2024 updated by: Orlando Martins, University of Coimbra

Erythritol Air Polishing in Mucositis Treatment: A Randomized Controlled Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Orlando Martins
  • Phone Number: +351 917298190
  • Email: orlmm@yahoo.com

Study Contact Backup

Study Locations

  • Portugal
      • Coimbra, Portugal
        • Recruiting
        • University of Coimbra
        • Contact:
        • Sub-Investigator:
          • Diogo Banaco
        • Sub-Investigator:
          • Isabel Poiares Baptista
        • Principal Investigator:
          • Orlando Martins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group Erythritol Monthly Applications
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
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
No Intervention: Control group
Patients will receive only oral hygiene instructions
Experimental: Test Group Erythritol Single Application
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Bleeding on Probing compared to baseline
Time Frame: Baseline, 3 months and 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Pocket Depth
Time Frame: Baseline, 3 months and 6 months
Measured in mm from the mucosal margin to most apical point of the pocket
Baseline, 3 months and 6 months
Plaque index (PI)
Time Frame: Baseline, 3 months and 6 months
assessed dichotomously as the presence or absence of plaque along the mucosal/gingival margin
Baseline, 3 months and 6 months
Gingival Recession
Time Frame: Baseline, 3 months and 6 months
Distance, measured in mm from the cementoenamel junction to the gingival margin
Baseline, 3 months and 6 months
Radiographic bone level
Time Frame: Baseline, 3 months and 6 months
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
Biochemical outcomes
Time Frame: Baseline, 3 months and 6 months
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
Complete Disease Resolution
Time Frame: 3 months and 6 months
Total Absence of bleeding on probing and deep probing pocket depths on the implant site
3 months and 6 months
Keratinized Tissue
Time Frame: Baseline, 3 months and 6 months
Measure in mm in the vestibular site
Baseline, 3 months and 6 months
Prosthetic Margin Level
Time Frame: Baseline, 3 months and 6 months
Level of the prosthetic implant connection regarding the gingival margin
Baseline, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Coimbra

Investigators

  • Study Director: Orlando Martins, Visiting Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 18, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mucositis_Erythritol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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