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

NCT03637946 | Completed DMC

• 2 other identifiers: FUMinasGerais02RBR-8m8cf2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-carious Cervical Lesions

Keywords

Resin composite; clinical trial; biocompatibility; cytokines

Outcome Measures

Primary Outcomes (1)

• FDI criteria

  The evaluation of the quality of the restoration will be evaluated using the FDI criteria and will be performed by two trained examiners at baseline and follow-up visits.The criteria has score given for each property with range from 1 to 5. Clinical assessments (Esthetic properties:surface brightness, surface and marginal color, color and translucency and anatomical form, Functional properties: marginal adaptation, fracture of material and retention, and Biological Properties: postoperative hypersensitivity, recurrence of caries, tooth integrity and adjacent mucosa)

  Up to 6 months

Secondary Outcomes (4)

• Clinical parameters: visible plaque index (IPV)

  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

• Clinical parameters: probing depth (PS)

  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;

• Clinical parameters: probing bleeding (SS)

  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

• Clinical parameters: gingival index (GI)

  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

Study Arms (1)

SHOFU Beautifil II LS

EXPERIMENTAL

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

Other: Device: SHOFU beautifil II LS

Interventions

Device: SHOFU beautifil II LS OTHER

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

SHOFU Beautifil II LS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

Study Sites (1)

Federal University Of Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-center, non-blinded, clinical trial 6 months in duration.

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 20, 2018
• Study Start: June 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: February 1, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)