Effect of Ozone Oil After Non-surgical Periodontal Treatment

NCT05838209 | Unknown DMC

• 1 other identifier: CAAE 89966418.8.0000.5626
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontal Diseases

Keywords

Periodontitis, Periodontal treatment, diabetes

Outcome Measures

Primary Outcomes (4)

• Plaque Index

  Percentage

  baseline

• Gingival Index

  Percentage

  baseline

• Probing Depth

  mm

  baseline

• clinical attachment level

  mm

  baseline

Secondary Outcomes (4)

• Plaque Index

  3 months

• Gingival Index

  3 months

• Probing Depth

  3 months

• clinical attachment levels

  3 months

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Drug: Control

Test

ACTIVE COMPARATOR

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

Drug: test

Interventions

test DRUG

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

Test

Control DRUG

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

Also known as: Placebo Control

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: patients over 18 years old
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Periodontitis
• Systemic type 2 diabetes

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Gabriela Alessandra da Cruz Galhardo Camargo

Nova Friburgo, Rio de Janeiro, 28625650, Brazil

RECRUITING

Related 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.

  PMID: 29265454 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

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

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 1, 2023
• Study Start: April 5, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

BR (1)