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Periodontal DiseasesNCT05838209

Effect of Ozone Oil After Non-surgical Periodontal Treatment

A study testing test in people with Periodontal Diseases, run by Universidade Federal Fluminense at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases
What is being tested?
test
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteBrazil
Study dates
5 Apr 2023to 1 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Periodontitis
  • Systemic type 2 diabetes

Who cannot join

  • Hypersensitivity to ozone oil
  • Osteoporosis types I and II
  • Alcoholism
  • Immunosuppressio
  • Pregnant and lactating
  • Physical/emotional stress drugs
Show all 9Show fewer
  • Use of antibiotics, anti-inflammatories and hormone
  • Oral candidiasis
  • Received periodontal treatment in the last six months prior to the procedure

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting

  • Gabriela Alessandra da Cruz Galhardo Camargo

    Nova Friburgo, Rio de Janeiro, 28625650

    Gabriela Alessandra da Cruz Galhardo Camargo, PhD, 55129818158, gabrielacruz@id.uff.br

    Recruiting

Other trials in Brazil

About this study

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

Being tested
test, Control
Keywords
Periodontitis, Periodontal treatment, diabetes
Medical subject headings
Periodontal Diseases, Periodontitis, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • testDrug

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

  • ControlDrug

    Also called Placebo Control

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

Study groups in NCT05838209
Study groupRoleWhat they receive
ControlPlacebo comparatorScaling and root planing + saline solution gel (control) will be adminster at probing depth > 5mm.
Receives: Drug: Control
TestActive comparatorScaling and root planing + Ozone Oil will be adminster at probing depth > 5mm.
Receives: Drug: test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plaque Index

    Percentage

    Measured: baseline

  2. Gingival Index

    Percentage

    Measured: baseline

  3. Probing Depth

    mm

    Measured: baseline

  4. clinical attachment level

    mm

    Measured: baseline

Secondary outcomes (4)

  1. Plaque Index

    Percentage

    Measured: 3 months

  2. Gingival Index

    Percentage

    Measured: 3 months

  3. Probing Depth

    mm

    Measured: 3 months

  4. clinical attachment levels

    mm

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start5 Apr 2023
  3. Primary completion1 Jun 2023 (estimated)
  4. Study completion1 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective clinical randomized controlled, split mouth designed, doble blinded study.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05838209
Sponsor's protocol ID
CAAE 89966418.8.0000.5626
Status last verified
Jun 2023
First submitted
5 Apr 2023
Last updated
7 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29265454

Questions about this trial

What is this clinical trial studying?

A study testing test in people with Periodontal Diseases, run by Universidade Federal Fluminense at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plaque Index (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05838209, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.

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