Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06455306

Erythritol Air Polishing in Mucositis Treatment: A Randomized Controlled Trial

Led by University of Coimbra · Updated on 2024-06-12

24

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of air polishing systems compared to only oral hygiene instruction for treating peri-implant mucositis in adults aged 18 to 80 with at least one dental implant affected by this condition. This randomized clinical trial aims to understand if adding air polishing with erythritol powder improves treatment outcomes for this common inflammatory condition around dental implants. Participants are randomly assigned to one of three groups: one receiving a single air polishing treatment with erythritol plus oral hygiene instructions, another receiving monthly air polishing treatments with erythritol for three months plus oral hygiene instructions, and a control group receiving oral hygiene instructions alone. Treatments are provided by experienced periodontists, and clinical and biochemical assessments are conducted at baseline, 3 months, and 6 months. During the study, participants attend scheduled appointments for clinical examinations, X-rays, and collection of peri-implant crevicular fluid to analyze inflammation markers. Researchers will measure bleeding on probing, pocket depth, plaque levels, gingival recession, bone levels, and other outcomes to compare changes over time among groups. The total study duration includes follow-ups at 3 and 6 months after initial treatment to assess treatment effects and disease resolution.

CONDITIONS

Brief Title

Erythritol Air Polishing in Mucositis Treatment

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 80 years
  • At least one dental implant in function for a minimum of one year
  • Diagnosed with peri-implant mucositis affecting at least one implant
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • Unable to understand the treatment protocol or unable to sign informed consent
  • Medical conditions preventing oral examination
  • Unable to perform oral hygiene due to physical or mental disorders
  • Uncontrolled systemic diseases, neoplasms, HIV or hepatitis infection, cardiovascular disease, blood disorders, or severe osteoporosis
  • Use of systemic antibiotics, corticosteroids, or immunosuppressive therapy within 3 months before baseline
  • Chronic use of nonsteroidal anti-inflammatory drugs or medications affecting periodontal health (e.g., phenytoin, cyclosporine)
  • Alcohol or drug addiction
  • Implants with mobility or occlusal overloads present in the affected site(s)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - Up to 3 months

Participants receive oral hygiene instructions and may receive air-polishing treatment with erythritol either once or monthly depending on their group assignment.

1 to 3 treatment visits depending on group assignment (in-person)

Follow-up

Duration - Up to 6 months

Participants attend follow-up visits for clinical examinations, radiographic assessments, and peri-implant crevicular fluid collection to monitor treatment outcomes.

Visits at 3 months and 6 months after baseline (in-person)

Trial Site Locations

Total: 1 location

1

University of Coimbra

Coimbra, Portugal

Actively Recruiting

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Research Team

O

Orlando Martins

D

Diogo Banaco

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Frequently Asked Questions

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Published Research Related To This Trial

Peri-implant health, peri-implant mucositis, and peri-implantitis: Case definitions and diagnostic considerations.

Stefan Renvert, G Rutger Persson, Flavia Q Pirih...

https://pubmed.ncbi.nlm.nih.gov/29926496

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.

Tord Berglundh, Gary Armitage, Mauricio G Araujo...

https://pubmed.ncbi.nlm.nih.gov/29926491

Prevalence and risk/protective indicators of peri-implant diseases: A university-representative cross-sectional study.

Mario Romandini, Cristina Lima, Ignacio Pedrinaci...

https://pubmed.ncbi.nlm.nih.gov/33210772