Effect of Ozone Oil After Non-surgical Periodontal Treatment

June 5, 2023 updated by: Gabriela Alessandra da Cruz Galhardo Camargo, Universidade Federal Fluminense

The goal of this clinical trial is to evaluate the use of ozone oil as an adjunctive of non-surgical periodontal treatment (NSPT) on diabetics type 2 patients (DM2) compared to control group with chronic periodontal disease.

The principal question is to evaluate if the ozone oil could improve periodontal clinical parameters.

Thirty-two sites of 16 diabetics type 2 patients (DM2) with moderate to advanced periodontal disease containing two sites with periodontal pocket depth (PPD) of > 5 mm were selected.

The treatment was distributed in 2 groups in the split mouth design: Control- scaling and root planing + saline solution (control) and Test - scaling and root planning + ozone oil

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

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

  • Brazil
    • RJ
      • Nova Friburgo, RJ, Brazil, 28625650
        • Recruiting
        • Gabriela Alessandra da Cruz Galhardo Camargo
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Periodontitis
  • Systemic type 2 diabetes

Exclusion Criteria:

  • Hypersensitivity to ozone oil
  • Osteoporosis types I and II
  • Alcoholism
  • Immunosuppressio
  • Pregnant and lactating
  • Physical/emotional stress drugs
  • Use of antibiotics, anti-inflammatories and hormone
  • Oral candidiasis
  • Received periodontal treatment in the last six months prior to the procedure

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Scaling and root planing + saline solution gel (control) will be adminster at probing depth > 5mm.
Drug: Control
saline solution 0.09% used as an adjunctive as scaling and root planing
Other Names:
  • Placebo Control
Active Comparator: Test
Scaling and root planing + Ozone Oil will be adminster at probing depth > 5mm.
Drug: test
Ozone oil used as an adjunctive of scaling and root planing and control,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: baseline
Percentage
baseline
Gingival Index
Time Frame: baseline
Percentage
baseline
Probing Depth
Time Frame: baseline
mm
baseline
clinical attachment level
Time Frame: baseline
mm
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: 3 months
Percentage
3 months
Gingival Index
Time Frame: 3 months
Percentage
3 months
Probing Depth
Time Frame: 3 months
mm
3 months
clinical attachment levels
Time Frame: 3 months
mm
3 months

Collaborators and Investigators

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

Sponsor

Universidade Federal Fluminense

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 5, 2023

Primary Completion (Estimated)

June 1, 2023

Study Completion (Estimated)

July 1, 2023

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 89966418.8.0000.5626

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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