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

July 8, 2021 updated by: Andrea Scribante, University of Pavia

Pilot Study for the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 and 2 months.
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.
Baseline, 1 and 2 months.
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.
Baseline, 1 and 2 months.
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%.
Baseline, 1 and 2 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2021

Primary Completion (Actual)

July 6, 2021

Study Completion (Actual)

July 8, 2021

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 9, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-AQUALAB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be available upon motivated request to Principal Investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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