Release of Organic Components of a GIOMER in Non-carious Cervical Lesion Restorations

NCT ID: NCT03637946

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2020-02-01

Brief Summary

To evaluated the clinical performance of composite resin restorations, considering also the evaluation of release of resin components into saliva and the presence cytokines in gingival fluid. Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were use. For in vitro assays, adhesive and resin specimens are being preparing for assessing the monomers degree of conversion (by FTIR), sorption and solubility and release of resinous components in ethanol and Ringer solutions (through a gas chromatography and mass spectroscopy - GC-MS). In the longitudinal clinical study clinical performance of restorations and periodontal response were evaluate.

Detailed Description

Release of components of a resin composite system containing pre-reagent vitreal particles: laboratory and patient studies. The objectives of this study was to evaluate physical and chemical properties of a methacrylate-based restorative system regarding to the release of resin components to the storage medium, to evaluate the clinical performance of composite resin restorations, considering also the evaluation of release of resin components into saliva and the presence of cytokines in gingival crevicular fluid. Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were use. For in vitro assays, adhesive and resin specimens are being preparing for assessing the monomers degree of conversion (by FTIR), sorption and solubility and release of resinous components in ethanol and Ringer solutions (through a gas chromatography and mass spectroscopy - GC-MS). In the longitudinal clinical study, patients who present a NCCL with restorative need were selecting. Prior to treatment, there will be periodontal evaluation, saliva and gingival crevicular fluid collection (controls). The lesions were restoring with the restorative system. After 10 min,7 days, 1 and 6 months, clinical performance of restorations and periodontal response were evaluate according to the criterion FDI. Additionally, in all of these evaluation periods samples of saliva and crevicular fluid are being collecting. Saliva samples will be analyze by GC-MS to identify the eventual presence of organic components derived from the restoration. The crevicular fluid samples were analyzing using ELISA for identification and quantification of interleukins.

Conditions

Non-carious Cervical Lesions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHOFU Beautifil II LS

Experimental: SHOFU Beautifil II LS Restorative system FL-Bond II (self-etching adhesive system)/ Beautifil II (composite restorative)

Group Type: EXPERIMENTAL

Device: SHOFU beautifil II LS

Intervention Type: OTHER

Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were used following manufacturer's instructions

Interventions

Device: SHOFU beautifil II LS

Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were used following manufacturer's instructions

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Over 18 years of age; Systemically healthy; Non-smoking;
• With good oral hygiene;
• Absent irreversible pulpal alteration;
• With the presence of a non-carious cervical lesion (LCNCs) that needs to be restored. This lesion should be non-carious, non-retentive, with at least 1 mm and up to 3 mm depth, should involve both enamel and dentin of vital teeth without mobility, and present hypersensitivity;
• Presence a natural tooth of the same position of the restored tooth, but in the opposite arch of the same jaw to be considered for the positive control;
• Periodontal parameters : Depth Probing (PS), Visible Plaque Index (IPV), Gingival Index (GI) and Probing Bleed Index (SS). The normal included were: PS = 1 to 3 mm, GI = 0, IPV = score 0 e SS = score 0.

• Individuals with clinical signs of parafunctional habits;
• Smoking;
• Individuals who have performed other restorations in the last 12 months;
• Pregnant women and infants;
• Periodontal sites that presented bleeding during crevicular fluid collection or sites that prevent proper collection of clinical parameters.

Exclusion Criteria

• With severe systemic alteration;
• In the use of antibiotics and anti-inflammatories in the last three months;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role: collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Tassiana Cançado Melo Sá

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University Of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

RBR-8m8cf2

Identifier Type: REGISTRY

Identifier Source: secondary_id

FUMinasGerais02

Identifier Type: -

Identifier Source: org_study_id