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

Primary Purpose

Peri-implant Mucositis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ozonized water
Placebo
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Mucositis focused on measuring ozonized water

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Trial Group

Placebo Group

Arm Description

Patients from this group will receive treatment with ozonized water.

Patients from this group will receive placebo with water.

Outcomes

Primary Outcome Measures

Change in PPD - Probing Depth
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)
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 Score
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)
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%.

Secondary Outcome Measures

Full Information

First Posted
April 13, 2021
Last Updated
July 8, 2021
Sponsor
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT04845087
Brief Title
Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.
Official Title
Pilot Study for the Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 24, 2021 (Actual)
Primary Completion Date
July 6, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis
Keywords
ozonized water

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trial Group
Arm Type
Experimental
Arm Description
Patients from this group will receive treatment with ozonized water.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Patients from this group will receive placebo with water.
Intervention Type
Other
Intervention Name(s)
Ozonized water
Intervention Description
Irrigation of dental implants with ozonized water
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Irrigation of dental implants with water
Primary Outcome Measure Information:
Title
Change in PPD - Probing Depth
Description
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.
Time Frame
Baseline, 1 and 2 months.
Title
Change in BOP - Bleeding on Probing (percentage)
Description
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.
Time Frame
Baseline, 1 and 2 months.
Title
Change in BS - Bleeding Score
Description
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.
Time Frame
Baseline, 1 and 2 months.
Title
Change in PI - Plaque Index (percentage)
Description
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%.
Time Frame
Baseline, 1 and 2 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Scribante, DDS, PhD.
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
City
Pavia
State/Province
Lombardy
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon motivated request to Principal Investigator.

Learn more about this trial

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

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