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Effect of Ozone Oil After Non-surgical Periodontal Treatment

Sponsor
Universidade Federal Fluminense (Other)
Overall Status
Recruiting
CT.gov ID
NCT05838209
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
1.9
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a prospective clinical randomized controlled, split mouth designed, doble blinded study.This is a prospective clinical randomized controlled, split mouth designed, doble blinded study.
Masking:
Double (Participant, Care Provider)
Masking Description:
Participants - The randomization performed will use the coin heads or tails method, Investigators -Two treatments at randomly chosen sites separate in two groups: Ozone oil use as an adjunctive of scaling and root planing and saline solution 0.09%, as a control, associate as an adjunctive of scaling and root planing. Ultrasonic scaler and Gracey curets use to remove all calculus and biofilms during scaling and root planing. The oils are numbere syringes labeled 1 and 2 for blinded applications, and 1 ml of each oil were administrated in a previous selected site. After removing baseline samples of biofilm, the scaling and root planing were performed using ultrasonic devices and manual Gracey curettes.
Primary Purpose:
Treatment
Official Title:
Effect of Ozone Oil After Non-surgical Periodontal Treatment
Actual Study Start Date :
Apr 5, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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,

    Outcome Measures

    Primary Outcome Measures

    1. Plaque Index [baseline]

      Percentage

    2. Gingival Index [baseline]

      Percentage

    3. Probing Depth [baseline]

      mm

    4. clinical attachment level [baseline]

      mm

    Secondary Outcome Measures

    1. Plaque Index [3 months]

      Percentage

    2. Gingival Index [3 months]

      Percentage

    3. Probing Depth [3 months]

      mm

    4. clinical attachment levels [3 months]

      mm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gabriela Alessandra da Cruz Galhardo Camargo Nova Friburgo RJ Brazil 28625650

    Sponsors and Collaborators

    • Universidade Federal Fluminense

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Gabriela Alessandra da Cruz Galhardo Camargo, Clinical Professor, Universidade Federal Fluminense
    ClinicalTrials.gov Identifier:
    NCT05838209
    Other Study ID Numbers:
    • CAAE 89966418.8.0000.5626
    First Posted:
    May 1, 2023
    Last Update Posted:
    May 1, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gabriela Alessandra da Cruz Galhardo Camargo, Clinical Professor, Universidade Federal Fluminense
    Periodontitis, Periodontal treatment, diabetes
    Additional relevant MeSH terms:
    Periodontal Diseases

    Study Results

    No Results Posted as of May 1, 2023