Effect of Ozone Oil After Non-surgical Periodontal Treatment

Not Applicable

Recruiting

• Conditions: Periodontal Diseases
• Interventions: Drug: Control; Drug: test

• Registration Number: NCT05838209
• Lead Sponsor: Universidade Federal Fluminense

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-05
• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-05-01
• Status Verified: 2023-06
• Primary Completion: 2023-06-01
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Scaling and root planing + saline solution gel (control) will be adminster at probing depth \> 5mm.
Test	test	Scaling and root planing + Ozone Oil will be adminster at probing depth \> 5mm.

Primary Outcome Measures

Name	Time	Method
Plaque Index	baseline	Percentage
Probing Depth	baseline	mm
clinical attachment level	baseline	mm
Gingival Index	baseline	Percentage

Secondary Outcome Measures

Name	Time	Method
Gingival Index	3 months	Percentage
Probing Depth	3 months	mm
clinical attachment levels	3 months	mm
Plaque Index	3 months	Percentage

Trial Locations

Locations (1)

Gabriela Alessandra da Cruz Galhardo Camargo; 🇧🇷 Nova Friburgo, RJ, Brazil