Effect of Ozone Oil After Non-surgical Periodontal Treatment

Periodontal Diseases Clinical Trial

Official title:

Effect of Ozone Oil After Non-surgical Periodontal Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838209
• Other study ID #: CAAE 89966418.8.0000.5626
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: June 2023
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Drug:
• test
Ozone oil used as an adjunctive of scaling and root planing and control,
• Control
saline solution 0.09% used as an adjunctive as scaling and root planing

Locations

Country	Name	City	State
Brazil	Gabriela Alessandra da Cruz Galhardo Camargo	Nova Friburgo	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Index	Percentage	baseline
Primary	Gingival Index	Percentage	baseline
Primary	Probing Depth	mm	baseline
Primary	clinical attachment level	mm	baseline
Secondary	Plaque Index	Percentage	3 months
Secondary	Gingival Index	Percentage	3 months
Secondary	Probing Depth	mm	3 months
Secondary	clinical attachment levels	mm	3 months