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Study on the filler content in flowable composite resin and its effect on the clinical performance of restorations in dental cavities close to the gingiva

Does the filler content in flowable composite resin influence clinical performance when restoring non-carious Cervical Lesions? randomized clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-984vvk7
Enrollment
Unknown
Registered
2025-10-23
Start date
2025-09-04
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

Tooth abrasion

Interventions

This is a randomized, controlled, double-blind, split-mouth clinical trial with two intervention arms. Forty adult patients of both sexes will be included, each with at least two non-carious cervical

Sponsors

Sociedade Civil Educacional Tuiuti Limitada
Lead Sponsor
Sociedade Civil Educacional Tuiuti Limitada
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adults aged 18 years or older of both sexes; good general and oral health according to the Simplified Oral Hygiene Index; presence of at least 20 functional teeth; presence of at least two non-carious cervical lesions located in enamel and dentin with a minimum depth of 1 millimeter and less than 50 percent of the cavosurface margin in enamel; vital and asymptomatic teeth without contact with removable partial denture clasps; teeth with clinically acceptable restorations on other surfaces; availability to attend follow-up appointments and to sign the informed consent form

Exclusion criteria

Exclusion criteria: Active periodontal disease with probing depth greater than 3 millimeters bleeding on probing or mobility equal to or greater than grade II; presence of parafunctional habits such as bruxism or clenching of teeth; current use of orthodontic appliances or complete dentures; smoking; pregnancy or lactation; teeth serving as abutments for fixed or removable dentures; inability to attend follow-up appointments or refusal to sign the informed consent form; known allergy or hypersensitivity to any dental material used in the study

Design outcomes

Primary

MeasureTime frame
The fracture and retention rates of restorations will be evaluated at 7 days and 6 months through direct clinical examination by two calibrated and blinded evaluators, using the FDI clinical criteria. Restorations will be classified as acceptable (scores A, B, or C) or unacceptable (scores D or E), and the cumulative failure rate will be calculated using the Kaplan-Meier method, with comparisons using the log-rank test (a = 0.05).

Secondary

MeasureTime frame
It is expected to evaluate marginal adaptation, surface texture, marginal discoloration, color stability and anatomical shape in 7 days and after 6 months, using the FDI clinical criteria, considering scores A, B or C as acceptable and scores D or E as unacceptable.;It is expected to evaluate postoperative sensitivity, presence of recurrent caries and periodontal response adjacent to the restorations in 7 days and after 6 months, through direct clinical examination and patient reports, recording the presence or absence of each condition.;It is expected to evaluate the operator's perception regarding ease of handling, material consistency, insertion control and general satisfaction immediately after each procedure, using a structured questionnaire with a 5-point Likert scale, with 1 being very bad and 5 being very good.

Countries

Brazil

Contacts

Public ContactThalita Matos

Universidade Tuiuti do Paraná

thalitamatos@live.com+55 (41) 3331-7668

Outcome results

None listed

Source: REBEC (via WHO ICTRP)