Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04845087
Enrollment
26
Registered
2021-04-14
Start date
2021-04-24
Completion date
2021-07-08
Last updated
2021-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implant Mucositis

Keywords

ozonized water

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.

Interventions

Irrigation of dental implants with ozonized water

OTHERPlacebo

Irrigation of dental implants with water

Sponsors

University of Pavia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in PPD - Probing DepthBaseline, 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.
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 ScoreBaseline, 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%.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026