Erythritol Air Polishing in Mucositis Treatment
- Conditions
- Peri-implant Mucositis
- Interventions
- Procedure: Single Air-polishing with erythritolProcedure: Air-polishing with erythritol at different time points
- Registration Number
- NCT06455306
- Lead Sponsor
- University of Coimbra
- 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 (-80Ā°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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Adults with at least one implant in function for a minimum of one year affected by peri-implant mucositis.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Group Erythritol Single Application Single Air-polishing with erythritol Patients will receive a single application of treatment with an air-polishing device with erythritol, in addition to oral hygiene instructions Test Group Erythritol Monthly Applications Air-polishing with erythritol at different time points Patients will receive monthly applications (months 0, 1, and 2) of treatment with an air-polishing device with erythritol, along with oral hygiene instructions
- Primary Outcome Measures
Name Time Method Changes in Bleeding on Probing compared to baseline 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
- Secondary Outcome Measures
Name Time Method Probing Pocket Depth Baseline, 3 months and 6 months Measured in mm from the mucosal margin to most apical point of the pocket
Plaque index (PI) Baseline, 3 months and 6 months assessed dichotomously as the presence or absence of plaque along the mucosal/gingival margin
Gingival Recession Baseline, 3 months and 6 months Distance, measured in mm from the cementoenamel junction to the gingival margin
Radiographic bone level 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
Keratinized Tissue Baseline, 3 months and 6 months Measure in mm in the vestibular site
Biochemical outcomes 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)
Complete Disease Resolution 3 months and 6 months Total Absence of bleeding on probing and deep probing pocket depths on the implant site
Prosthetic Margin Level Baseline, 3 months and 6 months Level of the prosthetic implant connection regarding the gingival margin
Trial Locations
- Locations (1)
University of Coimbra
šµš¹Coimbra, Portugal