Clinical trial NCT03637946: Release of Organic Components of a GIOMER in Non-carious Cervical Lesion Restorations
Official title: Release of Organic Components of a GIOMER in Non-carious Cervical Lesion Restorations: in Vitro and in Vivo Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-carious Cervical Lesions
Keywords: Resin composite
clinical trial
biocompatibility
cytokines
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2018-08-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-center, non-blinded, clinical trial 6 months in duration.
Primary purpose: TREATMENT

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.

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.

Exclusion Criteria:

* With severe systemic alteration;
* In the use of antibiotics and anti-inflammatories in the last three months;
* With periodontium with periodontal parameters different from those established in the inclusion criteria.
* 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.

Primary outcomes:
measure: FDI criteria
timeFrame: Up to 6 months
Secondary outcomes:
measure: Clinical parameters: visible plaque index (IPV)
timeFrame: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months
measure: Clinical parameters: probing depth (PS)
timeFrame: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months;
measure: Clinical parameters: probing bleeding (SS)
timeFrame: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months
measure: Clinical parameters: gingival index (GI)
timeFrame: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University Of Minas Gerais
state: Minas Gerais
Study officials:
References: