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Restorations of cavities near carious gingiva with single increment resin

Restoration of caries-free cervical lesions with composite bulk fill resin - clinical, randomized and blind study - : caries-free cervical lesions, bulk fill, gingival crevicular fluid, United States Public Health Service

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5syh8r
Enrollment
Unknown
Registered
2019-10-11
Start date
2017-10-07
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

Cervical free lesions of caries

Interventions

Experimental group 1: 30 non-carious cervical lesions will receive restorative treatment with Filtek Bulk fill composite resin Experimental group 2: 30 non-carious cervical lesions will receive restor
Procedure/surgery
k03.8

Sponsors

Universidade Estaudual do Oeste do Paraná
Lead Sponsor
Universidade Estaudual do Oeste do Paraná
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Adults 18 to 60 years of age; Lesions close to the gingival tissue present in structurally compromised posterior teeth (class V); Absence of periodontal disease; The teeth must have occlusal contact with the antagonist; Possessing occlusal balance and absence of premature contacts.

Exclusion criteria

Exclusion criteria: Possessing active periodontal disease; To have dental mobility in grades I, II and III; Possess uncontrolled caries activity; Xerostomia; Being in orthodontic treatment; Bearing mandibular temporal dysfunction; History of systemic diseases with repercussion in the gingiva and periodontal tissues; Adverse reaction history to any of the materials used in this study; To have a parafunctional habit; Use of myorelaxant apparatus; Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Restorations will be clinically evaluated by the USPHS (United States Public Health Services) criteria described by Cvar and Ryge in 1971 (Table 3) in the initial, 6, 12, 18 and 24 month periods.

Secondary

MeasureTime frame
The number of patients based on previous studies (Sartori et al., 2013) and the performance of the sampling test were based on an analysis of variance for a design of repeated measurements, as two experimental groups. Assuming an analysis power of 0.90, effect size of 0.25 and type I error of 0.05, with a duration over time, a total sample size of 15 restorations per group was defined. This project has not been implemented GPower 3.1.9.

Countries

Brazil

Contacts

Public ContactVeridiana Camilotti

Universidade Estaudual do Oeste do Paraná

vericamilotti@hotmail.com+55 45 3037-2206

Outcome results

None listed

Source: REBEC (via WHO ICTRP)