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Bisphenol-A release in orthodontic materials used to treat anterior open bite.

Bisphenol-A release and biocompatibility of orthodontic adhesive system used for spur bonding in patients with anterior open bite: In vivo study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6t74w6g
Enrollment
Unknown
Registered
2022-06-29
Start date
2018-08-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open bite

Interventions

The spur passive orthodontic appliance is an accepted method in children for correction of anterior open bite. So that they can release the by-products as Bis manufacturing materials it is necessary t
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Sponsors

Faculdade de Odontologia da Universidade Federal de Minas Gerais
Lead Sponsor
Faculdade de Odontologia da Universidade Federal de Minas Gerais
Collaborator

Eligibility

Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Subjects will be included in the study: Systemically healthy; with good oral hygiene; with presence of anterior open bite; Normal periodontal: The periodontal parameters adopted to assess the normal state will be those established by Lindhe, Lang and Karring (2014) and Carranza and Sznajder (1996). These parameters are Probing Depth, Visible Plaque Index, Gingival Index, and Probing Bleeding Index .

Exclusion criteria

Exclusion criteria: Subjects will be excluded from the study: With severe systemic alteration; on antibiotics and anti-inflammatory drugs in the last three months; with abnormal periodontium; patients with clinical signs of parafunctional habits; who have performed restorations in the last 12 months; periodontal sites that showed bleeding during crevicular fluid collection or sites that prevent adequate collection of clinical parameters.

Design outcomes

Primary

MeasureTime frame
To evaluate the expression of cytokines in gingival crevicular fluid (GCF) in children with open bite who will receive spur fixation as a treatment The GCF was quantified in the Periotron® 8000 device (Oralflow, PlainView, New York, NY, USA) immediately after each collection, in order to obtain greater precision. Then, the tapes were stored in appropriate Eppendorf-type plastic tubes and stored at -80°C until analyzed. To determine the volume of the FCG, the Periotron calibration was performed. Laboratory processing of GGF samples for analysis of cytokines IL-1ß, IL-6, IL-8, IL-12p70 and TNF: The extraction of gingival crevicular fluid samples was performed in two steps. 25 µL of cytokine extraction solution [PBS (0.4 mM NaCl, 10 mM NaPO4) with protease inhibitors (0.1 mM PMSF, 0.1 mM Benzethonium hydrochloric, 10 mM EDTA and 0.01 mg/ml) were added. mL Aprotinin A, pH 7.4) and Tween 20 (0.05%)], in each eppendorf containing the periopaper. The tubes were then vortexed for 30 seconds and then centrifuged for 10 min at 10,000 RPM at 4°C. The supernatant was removed and stored in a new eppendorf and the same process was repeated once more. At the end a total of 50 µL was obtained from each periopaper. The supernatants were pooled into a single eppendorf and vortexed. A pool was performed for the groups of upper and lower teeth from all collection times. Then, 50 µL of the supernatant were separated for cytokine analysis by CBA and the other samples were stored in a freezer at -80ºC. FCG analyzes were determined using the BD™ CBA Human Inflammatory Cytokines Kit for humans (BD Biosciences, San Diego, CA, USA) and analyzed on the BD FACSVerse Flow Cytometer (Becton Dickinson, San Jose, CA, USA) following the manufacturer's guidelines.;To analyze the release of by-products and quantify BisGMA and TEGDMA in the saliva of these patients. 1 mL of the sample and 1 mL of HPLC grade ethyl acetate were transferred to a 15 mL Falcon® tube. The tube was vortexed for 1 minute a

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactGabriel Tou

Universidade Federal de Minas Gerais

gabrieltou@hotmail.com55(031)984095480

Outcome results

None listed

Source: REBEC (via WHO ICTRP)