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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04845087
Recruitment Status : Completed
First Posted : April 14, 2021
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Andrea Scribante, University of Pavia

Study Description
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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.


Condition or disease Intervention/treatment Phase
Peri-implant Mucositis Other: Ozonized water Other: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study for the Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.
Actual Study Start Date : April 24, 2021
Actual Primary Completion Date : July 6, 2021
Actual Study Completion Date : July 8, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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%.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04845087


Locations
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Italy
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, Italy, 27100
Sponsors and Collaborators
University of Pavia
Investigators
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Principal Investigator: Andrea Scribante, DDS, PhD. University of Pavia
More Information
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Responsible Party: Andrea Scribante, Research Resident, Principal Investigator, University of Pavia
ClinicalTrials.gov Identifier: NCT04845087    
Other Study ID Numbers: 2021-AQUALAB
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available upon motivated request to Principal Investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrea Scribante, University of Pavia:
ozonized water
Additional relevant MeSH terms:
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Mucositis
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases