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

NCT ID: NCT04845087

Last Updated: 2021-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-24

Study Completion Date

2021-07-08

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.

Conditions

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Peri-implant Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Trial Group

Patients from this group will receive treatment with ozonized water.

Group Type EXPERIMENTAL

Ozonized water

Intervention Type OTHER

Irrigation of dental implants with ozonized water

Placebo Group

Patients from this group will receive placebo with water.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Irrigation of dental implants with water

Interventions

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Ozonized water

Irrigation of dental implants with ozonized water

Intervention Type OTHER

Placebo

Irrigation of dental implants with water

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Research Resident, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, DDS, PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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

Pavia, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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2021-AQUALAB

Identifier Type: -

Identifier Source: org_study_id

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