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

NCT06507592 | Active Not Recruiting

• 1 other identifier: N. Prot. 0637
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Inflammation; Oxidative Stress; TNF-α

Keywords

clear aligners; fixed appliances; oxidative stress; inflammation; orthodontic treatment

Outcome Measures

Primary Outcomes (1)

• Oxidative-reduction and inflammation

  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 Outcomes (1)

• Potential risk factors

  Two years

Study Arms (2)

Fixed Appliances (FA)

OTHER

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

Clear Aligners (CA)

OTHER

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

Interventions

Saliva samples collection DIAGNOSTIC_TEST

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).

Clear Aligners (CA); Fixed Appliances (FA)

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Multidisciplinary Department of Medical-Surgical and Dental Specialties

Naples, 80138, Italy

Location

Related Publications (19)

• Schipper RG, Silletti E, Vingerhoeds MH. Saliva as research material: biochemical, physicochemical and practical aspects. Arch Oral Biol. 2007 Dec;52(12):1114-35. doi: 10.1016/j.archoralbio.2007.06.009. Epub 2007 Aug 10.

  PMID: 17692813 BACKGROUND

• Kovac V, Poljsak B, Perinetti G, Primozic J. Systemic Level of Oxidative Stress during Orthodontic Treatment with Fixed Appliances. Biomed Res Int. 2019 May 23;2019:5063565. doi: 10.1155/2019/5063565. eCollection 2019.

  PMID: 31240214 BACKGROUND

• Angelieri F, Carlin V, Martins RA, Ribeiro DA. Biomonitoring of mutagenicity and cytotoxicity in patients undergoing fixed orthodontic therapy. Am J Orthod Dentofacial Orthop. 2011 Apr;139(4 Suppl):e399-404. doi: 10.1016/j.ajodo.2009.06.029.

  PMID: 21435548 BACKGROUND

• Guler C, Toy E, Ozturk F, Gunes D, Karabulut AB, Otlu O. Evaluation of salivary total oxidant-antioxidant status and DNA damage of children undergoing fixed orthodontic therapy. Angle Orthod. 2015 Mar;85(2):239-44. doi: 10.2319/110113-798.1. Epub 2014 Jun 20.

  PMID: 24949910 BACKGROUND

• Krifka S, Hiller KA, Spagnuolo G, Jewett A, Schmalz G, Schweikl H. The influence of glutathione on redox regulation by antioxidant proteins and apoptosis in macrophages exposed to 2-hydroxyethyl methacrylate (HEMA). Biomaterials. 2012 Jul;33(21):5177-86. doi: 10.1016/j.biomaterials.2012.04.013. Epub 2012 Apr 24.

  PMID: 22534037 BACKGROUND

• Ambati M, Rani KR, Reddy PV, Suryaprasanna J, Dasari R, Gireddy H. Evaluation of oxidative stress in chronic periodontitis patients following systemic antioxidant supplementation: A clinical and biochemical study. J Nat Sci Biol Med. 2017 Jan-Jun;8(1):99-103. doi: 10.4103/0976-9668.198366.

  PMID: 28250683 BACKGROUND

• Ichiishi E, Li XK, Iorio EL. Oxidative Stress and Diseases: Clinical Trials and Approaches. Oxid Med Cell Longev. 2016;2016:3458276. doi: 10.1155/2016/3458276. Epub 2016 Oct 19. No abstract available.

  PMID: 27833701 BACKGROUND

• Chiou CC, Chang PY, Chan EC, Wu TL, Tsao KC, Wu JT. Urinary 8-hydroxydeoxyguanosine and its analogs as DNA marker of oxidative stress: development of an ELISA and measurement in both bladder and prostate cancers. Clin Chim Acta. 2003 Aug;334(1-2):87-94. doi: 10.1016/s0009-8981(03)00191-8.

  PMID: 12867278 BACKGROUND

• Evans MD, Dizdaroglu M, Cooke MS. Oxidative DNA damage and disease: induction, repair and significance. Mutat Res. 2004 Sep;567(1):1-61. doi: 10.1016/j.mrrev.2003.11.001.

  PMID: 15341901 BACKGROUND

• undefined

  BACKGROUND

• Kaplan MD, Baum BJ. The functions of saliva. Dysphagia. 1993;8(3):225-9. doi: 10.1007/BF01354542.

  PMID: 8359042 BACKGROUND

• Cuevas-Cordoba B, Santiago-Garcia J. Saliva: a fluid of study for OMICS. OMICS. 2014 Feb;18(2):87-97. doi: 10.1089/omi.2013.0064. Epub 2014 Jan 3.

  PMID: 24404837 BACKGROUND

• Humphrey SP, Williamson RT. A review of saliva: normal composition, flow, and function. J Prosthet Dent. 2001 Feb;85(2):162-9. doi: 10.1067/mpr.2001.113778.

  PMID: 11208206 BACKGROUND

• Takane M, Sugano N, Iwasaki H, Iwano Y, Shimizu N, Ito K. New biomarker evidence of oxidative DNA damage in whole saliva from clinically healthy and periodontally diseased individuals. J Periodontol. 2002 May;73(5):551-4. doi: 10.1902/jop.2002.73.5.551.

  PMID: 12027259 BACKGROUND

• Sezer U, Cicek Y, Canakci CF. Increased salivary levels of 8-hydroxydeoxyguanosine may be a marker for disease activity for periodontitis. Dis Markers. 2012;32(3):165-72. doi: 10.3233/DMA-2011-0876.

  PMID: 22377732 BACKGROUND

• Kumar D, Pandey RK, Agrawal D, Agrawal D. An estimation and evaluation of total antioxidant capacity of saliva in children with severe early childhood caries. Int J Paediatr Dent. 2011 Nov;21(6):459-64. doi: 10.1111/j.1365-263X.2011.01154.x. Epub 2011 Jul 1.

  PMID: 21718374 BACKGROUND

• Beyersmann D, Hartwig A. Carcinogenic metal compounds: recent insight into molecular and cellular mechanisms. Arch Toxicol. 2008 Aug;82(8):493-512. doi: 10.1007/s00204-008-0313-y. Epub 2008 May 22.

  PMID: 18496671 BACKGROUND

• Canakci CF, Canakci V, Tatar A, Eltas A, Sezer U, Cicek Y, Oztas S. Increased salivary level of 8-hydroxydeoxyguanosine is a marker of premature oxidative mitochondrial DNA damage in gingival tissue of patients with periodontitis. Arch Immunol Ther Exp (Warsz). 2009 May-Jun;57(3):205-11. doi: 10.1007/s00005-009-0026-9. Epub 2009 May 29.

  PMID: 19479201 BACKGROUND

• Manuelli M, Marcolina M, Nardi N, Bertossi D, De Santis D, Ricciardi G, Luciano U, Nocini R, Mainardi A, Lissoni A, Abati S, Lucchese A. Oral mucosal complications in orthodontic treatment. Minerva Stomatol. 2019 Apr;68(2):84-88. doi: 10.23736/S0026-4970.18.04127-4.

  PMID: 30854838 BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vincenzo Grassia, DDs, PhD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: July 18, 2024
• Study Start: January 27, 2023
• Primary Completion: May 31, 2024
• Study Completion: December 21, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The data will be available after paper publication for at least 2 years
• Access Criteria: Person involved in research and affiliated in recognized Institution

Locations

IT (1)