Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.
- Conditions
- Peri-implant Mucositis
- Interventions
- Other: PlaceboOther: Ozonized water
- Registration Number
- NCT04845087
- Lead Sponsor
- University of Pavia
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Presence of one or more dental implants
- Presence of peri-implant mucositis at least at one implant
- Bleeding Score > 0
- Patents without dental implants
- Presence of systemic diseases
- Patients with cardiac pacemaker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group Placebo Patients from this group will receive placebo with water. Trial Group Ozonized water Patients from this group will receive treatment with ozonized water.
- Primary Outcome Measures
Name Time Method Change in BOP - Bleeding on Probing (percentage) Baseline, 1 and 2 months. 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.
Change in BS - Bleeding Score Baseline, 1 and 2 months. 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.Change in PI - Plaque Index (percentage) Baseline, 1 and 2 months. 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%.Change in PPD - Probing Depth Baseline, 1 and 2 months. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
🇮🇹Pavia, Lombardy, Italy