Effect of Ozone Oil After Non-surgical Periodontal Treatment

Universidade Federal Fluminense

Status: Enrolling

Conditions: Periodontal Diseases

Treatments: Drug: test; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05838209

CAAE 89966418.8.0000.5626

Details and patient eligibility

About

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

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Control

Test

Active Comparator group

Description:

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

Treatment:

Drug: test