Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.

Study Overview
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Brief Summary
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The aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants. Patients willl undergo professional dental hygiene also with the use of glycine powders, then they will be randomly divided into two groups: Trial Group: irrigation of peri-implant periodontium with mucositis with ozonized water. Placebo Group: irrigation of peri-implant periodontium with mucositis with water. Periodontal indices will be recorded at the baseline, after 1 and 2 months. After 1 and 2 months, only glycine powders will be performed, together with ozonized water or water irrigation and the collection of periodontal indices.

Detailed Description
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The aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants. Patients who respond to eligibility criteria and that will sign the informed consent will undergo a professional oral hygiene procedure. Patients willl undergo professional dental hygiene also with the use of glycine powders. Then, glycine powders air-flow will be administered. Then they will be randomly divided into two groups: Trial Group: irrigation of peri-implant periodontium with mucositis with ozonized water. Placebo Group: irrigation of peri-implant periodontium with mucositis with water. Periodontal indices will be recorded at the baseline, after 1 and 2 months. After 1 and 2 months, only glycine powder will be performed, together with ozonized water/water irrigation and the collection of periodontal indices.

Official Title
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Pilot Study for the Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.

Conditions
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Peri-implant Mucositis

Intervention / Treatment
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* Other: Ozonized water
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of one or more dental implants Presence of peri-implant mucositis at least at one implant Bleeding Score > 0 Exclusion Criteria: Patents without dental implants Presence of systemic diseases Patients with cardiac pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial Group<br>Patients from this group will receive treatment with ozonized water. | Other: Ozonized water<br>* Irrigation of dental implants with ozonized water<br>|
| Placebo Comparator: Placebo Group<br>Patients from this group will receive placebo with water. | Other: Placebo<br>* Irrigation of dental implants with water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PPD - Probing Depth | Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus of the peri-implant pocket, evaluated at 6 sites. | Baseline, 1 and 2 months. | 
| Change in BOP - Bleeding on Probing (percentage) | Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PD, detected on 6 sites. | Baseline, 1 and 2 months. | 
| Change in BS - Bleeding Score | Scoring criteria: 0: no bleeding; 1: punctiform bleeding in the site of probing; 2: bleeding within the gingival border; 3: bleeding outside the gingival border. | Baseline, 1 and 2 months. | 
| Change in PI - Plaque Index (percentage) | Site-specific assessment of the presence or visible plaque detected on 4 sites with a disclosing tables. Percentage of sites with plaque determines the PI%. | Baseline, 1 and 2 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ozonized water