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Effect of Ozone Oil After Non-surgical Periodontal Treatment

Primary Purpose

Periodontal Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
test
Control
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Periodontitis, Periodontal treatment, diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gabriela Alessandra da Cruz Galhardo CamargoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Test

Arm Description

Scaling and root planing + saline solution gel (control) will be adminster at probing depth > 5mm.

Scaling and root planing + Ozone Oil will be adminster at probing depth > 5mm.

Outcomes

Primary Outcome Measures

Plaque Index
Percentage
Gingival Index
Percentage
Probing Depth
mm
clinical attachment level
mm

Secondary Outcome Measures

Plaque Index
Percentage
Gingival Index
Percentage
Probing Depth
mm
clinical attachment levels
mm

Full Information

First Posted
April 5, 2023
Last Updated
June 5, 2023
Sponsor
Universidade Federal Fluminense
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1. Study Identification

Unique Protocol Identification Number
NCT05838209
Brief Title
Effect of Ozone Oil After Non-surgical Periodontal Treatment
Official Title
Effect of Ozone Oil After Non-surgical Periodontal Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Periodontitis, Periodontal treatment, diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective clinical randomized controlled, split mouth designed, doble blinded study.
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Scaling and root planing + saline solution gel (control) will be adminster at probing depth > 5mm.
Arm Title
Test
Arm Type
Active Comparator
Arm Description
Scaling and root planing + Ozone Oil will be adminster at probing depth > 5mm.
Intervention Type
Drug
Intervention Name(s)
test
Intervention Description
Ozone oil used as an adjunctive of scaling and root planing and control,
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
Placebo Control
Intervention Description
saline solution 0.09% used as an adjunctive as scaling and root planing
Primary Outcome Measure Information:
Title
Plaque Index
Description
Percentage
Time Frame
baseline
Title
Gingival Index
Description
Percentage
Time Frame
baseline
Title
Probing Depth
Description
mm
Time Frame
baseline
Title
clinical attachment level
Description
mm
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Plaque Index
Description
Percentage
Time Frame
3 months
Title
Gingival Index
Description
Percentage
Time Frame
3 months
Title
Probing Depth
Description
mm
Time Frame
3 months
Title
clinical attachment levels
Description
mm
Time Frame
3 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
patients over 18 years old
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Gabriela Alessandra da Cruz Galhardo Camargo
City
Nova Friburgo
State/Province
RJ
ZIP/Postal Code
28625650
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Alessandra da Cruz Galhardo Camargo, PhD
Phone
55129818158
Email
gabrielacruz@id.uff.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29265454
Citation
Mauri-Obradors E, Merlos A, Estrugo-Devesa A, Jane-Salas E, Lopez-Lopez J, Vinas M. Benefits of non-surgical periodontal treatment in patients with type 2 diabetes mellitus and chronic periodontitis: A randomized controlled trial. J Clin Periodontol. 2018 Mar;45(3):345-353. doi: 10.1111/jcpe.12858. Epub 2018 Jan 19.
Results Reference
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Effect of Ozone Oil After Non-surgical Periodontal Treatment

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