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Laboratory and clinical evaluation of a resin restorative system without bisphenol a used for gluing orthodontic brackets

In vitro and in vivo evaluation of a resin restorative system bisphenol a free used for fixation of orthodontic brackets

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-33k97n
Enrollment
Unknown
Registered
2019-03-21
Start date
2018-11-19
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

Healthy humans undergoing orthodontic treatment will be screened for assesment of bisphenol-A in saliva Specific descriptors: Bis-Phenol A-Glycidyl Methacrylate

Interventions

In vitro analysis of a bisphenol A free resin restorative system by gas chromatography to verify the absence of the compound studied with samples of 4 specimens for each system - Transbond XT, Orthoc
Mechanical shear bond and micro-shear bond tests in the resin restorative system free of bisphenol A (Resin Vittra FGM - conventional and modified technique) and in the control group (Transbond XT) to
To perform in vivo analysis by collecting saliva samples (5 times - baseline, 30 minutes after orthodontic bonding, 24 hours, 7 days and 30 days) from patients who will receive orthodontic appliances
Procedure/surgery
E06.658.453.590
D003764
D003188

Sponsors

Faculdade de Odontologia de Ribeirão Preto
Lead Sponsor
Faculdade de Odontologia de Ribeirão Preto
Collaborator

Eligibility

Age
12 Years to 20 Years

Inclusion criteria

Inclusion criteria: Age between 12 and 20 years; without gender preference; with complete permanent dentition; without lesions of caries and or periodontal disease; nonsmokers who will start treatment with fixed orthodontic appliances at the Orthodontics Specialization Clinic of the School of Dentistry of Ribeirão Preto USP; Patients should be good general health; have not received restorations in composite resins and or sealants in the last three months and do not engage in occupations that may be linked to BPA exposure.

Exclusion criteria

Exclusion criteria: Patients who are not in the criteria described in the inclusion; Patients who have received restorations in composite resins and or sealants in the last three months; and patients who have occupations related to BPA exposure.

Design outcomes

Primary

MeasureTime frame
It is estimated with this research that the test materials (Ambar APS adhesive and VIttra APS resin) are actually BPA free according to chromatographic chemical evaluation;It is estimated with this research that the test materials (Ambar APS adhesive and VIttra APS resin) they present good mechanical resistance compatible with orthodontic forces after undergoing shear and micro-shear bond tests.

Secondary

MeasureTime frame
It is estimated that the test materials presents good mechanical resistance compatible with clinical orthodontic forces (5 a 8 MPa);It is estimated that the test materials do not alter salivary levels of Bisphenol-A in patients who have orthodontic appliances fixed with the test material, condition assessed by gas chromatography and analysis of orthodontic bracket survival and adhesive remnant index.

Countries

Brazil

Contacts

Public ContactRenata Zoraida Delgado

Faculdade de Odontologia de Ribeirão Preto

renatazrdelgado@usp.br+55-45-999488979

Outcome results

None listed

Source: REBEC (via WHO ICTRP)