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Clinical evaluation of a chemical active composite in atraumatic restorative treatment in primary teeth: randomized, double-blind clinical trial

Clinical evaluation of a self-polymerizing composite in atraumatic restorative treatment in primary teeth: randomized, double-blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2n2g2p5
Enrollment
Unknown
Registered
2024-06-20
Start date
2025-01-01
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

Dental Caries

Interventions

This study aims to evaluate the clinical performance of a new self-polymerizing composite in the context of atraumatic restorative treatment in class II cavities in primary molars. 236 patients betwee

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Age
4 Years to 8 Years

Inclusion criteria

Inclusion criteria: Patients with one class II cavities in deciduous molars; healthy and cooperative patients; patients between 4 and 8 years old; be male or female

Exclusion criteria

Exclusion criteria: Patients with systemic diseases; patients with erosion, bruxism and incisal wear; use of orthodontic appliances; allergy to the materials used

Design outcomes

Primary

MeasureTime frame
Assess the clinical performance of the new composite resin Stela (SDI) when used in Atraumatic Restorative Treatments (ART) in deciduous molars over time

Secondary

MeasureTime frame
Analyze the functional properties (fracture and retention, marginal adaptation, wear, proximal contact, and radiographic evaluation when necessary) in deciduous molars using the new composite resin Stela in capsule presentation, at baseline, 7 days, and after 3, 6, 12, and 24 months, compared to a conventional glass ionomer cement;Examine the biological properties (caries recurrence and tooth integrity) in deciduous molars using the new composite resin Stela in capsule presentation, at baseline, 7 days, and after 3, 6, 12, and 24 months, compared to a conventional glass ionomer cement;Determine the assessment criteria for restorations using the ART technique and modified USPHS criteria in deciduous molars using the new composite resin Stela in capsule presentation, at baseline, 7 days, and after 3, 6, 12, and 24 months, compared to a conventional glass ionomer cement

Countries

Brazil

Contacts

Public ContactEmanuel Hul

Universidade Estadual de Ponta Grossa

emanuelhul1234@gmail.com+55 (42) 999479710

Outcome results

None listed

Source: REBEC (via WHO ICTRP)