Oxidative-reductive Processes and the Degree of Inflammation in Saliva With Conventional Brackets and Clear Aligners

July 11, 2024 updated by: Vincenzo Grassia, University of Campania "Luigi Vanvitelli"

In Vivo Evaluation of the Differences in Oxidative-reductive Processes in Saliva During Treatment With Conventional Brackets and Clear Aligners

The purpose of this prospective observational study is to evaluate the differences in oxidative-reductive processes and the degree of inflammation in saliva during treatment with conventional brackets and clear aligners. The evaluation will be performed by determining the salivary values of Total oxidant status (TOS), total antioxidant status (TAS) and 8-hidroxy-2'-deoxyguanosine (8OHdG).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The differences between production of free radicals and the antioxidant capacity of a system is called oxidative stress, this leads oxidative damages to macromolecules, including lipids and proteins.

Oxidative stress occurs in the tissues when the normal balance between ROS production (extracellular Reactive Oxygen Species) and the antioxidant defense shifts in favor of the first; this situation can result from an excess of ROS and/or the reduction of antioxidants. Some ROS types (e.g. superoxide and hydroxyl radicals, hydrogen peroxide, hypochlorous acid) are capable to directly damage proteins, carbohydrates, DNA and lipids; furthermore, ROS production and an altered redox state of tissues can modulate the expression of a variety of immune and inflammatory molecules through redox sensitive transcription factors (eg NF-kB, AP-1), causing thus indirect tissue damage such as inflammation.

Antioxidants agents are found in all biological species to protect against the potential harmful effects of processes or reactions that cause excessive oxidation. Therefore, biological antioxidants represent an important part of our diet and, together with intracellular antioxidants and antioxidant enzyme systems, may prevent various diseases. Antioxidant defense systems are very complex and for this reason it is essential to evaluate the quantity and / or activity of the different systems when evaluating their in vivo state.

Studies on the antioxidant defense systems present in saliva and their relationship with oral diseases are still few. Despite markers of oxidative stress have been found in saliva in presence of systemic and oral diseases, including inflammatory diseases such as gingivitis, periodontitis, caries and oral cancer.4, 15 During an orthodontic treatment, which often lasts for years, some components of the used orthodontic appliance can be released into the oral environment and saliva. The release of these components and their diffusion can cause various adverse effects in the body, such as allergic reactions, systemic toxicity, cytotoxicity, mutagenicity and carcinogenicity. Although there has been satisfactory development of orthodontic materials, the biocompatibility of these materials is usually not well known. The evaluation of these characteristics of orthodontic materials is as important aspect as their physiological or mechanical properties. However, the studies on these characteristics are limited, and they are mostly related to the cytotoxic effects of orthodontic adhesives. The total state of the oxidant (TOS) and the antioxidant (TAS) reflects the oxidative state and provides information on the body's antioxidant capacity. Oxidative damage to DNA can be detected by chemical, physical and enzymatic methods. 8-hydroxyoxiguanosin (8-OHdG) is an oxidized nucleoside which is excreted in body fluids for DNA repair. Several studies have shown that 8-OHdG in body fluids can act as a biomarker of oxidative stress and 8-OHdG is commonly used as a marker to evaluate oxidative DNA damage in disorders including chronic inflammatory diseases. Previous studies have in fact indicated a possible relationship between the salivary levels of 8-OHdG and the diseased periodontium. However, the levels of TOS, TAS and 8-OHdG in patients undergoing therapy with conventional brackets and with clear aligners has not yet been studied.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80138
        • Multidisciplinary department of Medical-Surgical and Dental Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age between 10 and 18 years
  • patients with no orthodontic devices in the mouth
  • patients requiring orthodontic treatment
  • patients who have good oral hygiene
  • patients without gingival inflammation

Exclusion Criteria:

  • patients with systemic diseases or infections
  • patients with previous orthodontic treatments
  • patients on drugs or assuming alcohol
  • smoking patients
  • patients with enamel decalcification or fillings

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fixed Appliances (FA)
13 patients with fixed appliances, between 10 and 18 years of age, with good oral hygiene and without gingival inflammation, has been recruited
Diagnostic test: Saliva samples collection
The first sample of saliva was be taken before the start of the treatment and considered as the control sample (T0); the second sample was be taken one month after the start of the treatment (T1) and the third one after three months (T2).
Other: Clear Aligners (CA)
13 patients with clear aligners, between 10 and 18 years of age, with good oral hygiene and without gingival inflammation, has been recruited
Diagnostic test: Saliva samples collection
The first sample of saliva was be taken before the start of the treatment and considered as the control sample (T0); the second sample was be taken one month after the start of the treatment (T1) and the third one after three months (T2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxidative-reduction and inflammation
Time Frame: One year
The Total Antioxidant Status (TAS) in saliva samples was measured using a N 2 615700-1KIT Total Antioxidant Status Assay Kit, a colorimetric assay for antioxidant levels in serum or plasma. The Total Oxidant Status (TOS) was measured with a CS0790-1KT Antioxidant Assay Kit, which includes all necessary reagents to measure total antioxidant capacity in plasma, serum, urine, saliva, cells, and tissue lysates. It also measures the radical cation (ABTS+) scavenging capacity. The 8-Hydroxy-2'-deoxyguanosine (8-OHdG) and Tumor Necrosis Factor-α (TNF-α) levels were determined using an E-EL-H0109 HUMAN TNF-ALPHA ELISA KIT, which detects protein levels quantitatively in serum, plasma, or cell lysate supernatants.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potential risk factors
Time Frame: Two years
Using plastic-based or metallic materials for orthodontic devices can increase saliva's oxidative and inflammatory status, potentially correlating with conditions like gingivitis, dental caries, periodontitis, or minor lesions such as aphthous ulcers. Oxidative stress impairs the ability to counteract further pathological events. Free radicals or reactive oxygen species (ROS) are typically generated during biochemical redox reactions as part of normal cell metabolism (for protection against infectious agents) and in response to environmental factors like UV radiation, cigarette smoke, pollutants, and gamma radiation. Once formed, ROS can attack cellular components in the mouth, damaging lipids, proteins, and DNA in oral tissues. This damage can initiate or exacerbate oral diseases, including gingivitis, dental caries, periodontitis, and other inflammatory conditions.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Investigators

  • Principal Investigator: Vincenzo Grassia, DDs, PhD, University of Campania "Luigi Vanvitelli"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Estimated)

December 21, 2024

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N. Prot. 0637

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

anyone can contact the PI by mail and ask two share the IPD. All data will be stored in a cloud available by University of Campania. The PI will share a link to accede to the files.

IPD Sharing Time Frame

The data will be available after paper publication for at least 2 years

IPD Sharing Access Criteria

Person involved in research and affiliated in recognized Institution

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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