Effect of Ozone Oil After Non-surgical Periodontal Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-05

Study Completion Date

2023-07-01

Brief Summary

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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

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Detailed Description

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Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective clinical randomized controlled, split mouth designed, doble blinded study.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

saline solution 0.09% used as an adjunctive as scaling and root planing

Test

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

Group Type ACTIVE_COMPARATOR

test

Intervention Type DRUG

Ozone oil used as an adjunctive of scaling and root planing and control,

Interventions

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test

Ozone oil used as an adjunctive of scaling and root planing and control,

Intervention Type DRUG

Control

saline solution 0.09% used as an adjunctive as scaling and root planing

Intervention Type DRUG

Other Intervention Names

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Placebo Control

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes