Clinical trial NCT06455306: Erythritol Air Polishing in Mucositis Treatment
Official title: Erythritol Air Polishing in Mucositis Treatment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-implant Mucositis
Keywords: peri-implant mucositis
erythritol powder air-polishing
non-surgical treatment
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Bleeding on Probing compared to baseline
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Probing Pocket Depth
timeFrame: Baseline, 3 months and 6 months
measure: Plaque index (PI)
timeFrame: Baseline, 3 months and 6 months
measure: Gingival Recession
timeFrame: Baseline, 3 months and 6 months
measure: Radiographic bone level
timeFrame: Baseline, 3 months and 6 months
measure: Biochemical outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Complete Disease Resolution
timeFrame: 3 months and 6 months
measure: Keratinized Tissue
timeFrame: Baseline, 3 months and 6 months
measure: Prosthetic Margin Level
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: University of Coimbra
Study officials:
affiliation: Visiting Assistant Professor
name: Orlando Martins
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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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.
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.
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.