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Completed

NCT Number: NCT04845087

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

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.

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Key information

Conditions

Peri-implant Mucositis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozonized water

Other

Irrigation of dental implants with ozonized water

Placebo

Other

Irrigation of dental implants with water

Primary outcomes

  1. Change in PPD - Probing Depth

    Time frame: 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.

  2. Change in BOP - Bleeding on Probing (percentage)

    Time frame: 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.

  3. Change in BS - Bleeding Score

    Time frame: 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.

  4. Change in PI - Plaque Index (percentage)

    Time frame: 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%.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 14, 2021
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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