Skip to content

Clinical Evaluation of Posterior Direct Restoration in Adolescents

Clinical Evaluation of Posterior Direct Restoration in Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03936855
Enrollment
54
Registered
2019-05-03
Start date
2016-01-31
Completion date
2018-09-30
Last updated
2019-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Composite Resins

Brief summary

The present study aims to evaluate the performance of direct restorations with bulk fill resins in molars with great structural loss, with endodontic treatment. The behavior of class II restorations in 68 molars endodontically treated with bulk fill resin and incremental technique will be evaluated by means of a randomized clinical trial with a two-year follow-up. This project aims to evaluate the performance of this new restorative strategy that can greatly contribute to restorations of posterior teeth.

Detailed description

Sixty-eight endodontically treated molars were restored in 54 adolescents (10-18 years old, mean= 14.0 +- 2.4). Teeth were randomly assigned to the incremental filling technique (Filtek Z230/Vitremer, 3M-ESPE, n = 31) or high viscosity bulk fill technique (Filtek Bulk Fill Posterior, 3M-ESPE, n = 37). The restorations were clinically evaluated at baseline, 12 and 24 months by two independent raters using modified United States Public Health Service criteria. Data analysis included descriptive statistics, Mann-Whitney and Friedman non-parametric tests, and Generalized Estimating Equation (GEE) analysis.

Interventions

PROCEDUREDirect composite resin

For both groups: The teeth will have the enamel surface conditioned with 37% phosphoric acid. For the restorative procedure, the same adhesive system will be used GROUP ACTIVE COMPARATOR 1. Insert resin-modified glass ionomer cement into the pulp chamber; 2. Complete the restoration by incremental technique using conventional composite resin in increments of 2mm; EXPERIMENTAL GROUP 1. Insert Bulk Fill composite inside the pulp chamber to the height of 5 mm; 2. Complete the insertion of the Bulk Fill resin to the limit of the caval surface angle in the occlusal

Sponsors

Coordination for the Improvement of Higher Education Personnel
CollaboratorOTHER
Fundação de Amparo à Pesquisa do estado de Minas Gerais
CollaboratorOTHER
Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Renata Afonso da Silva Pereira
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Adolescents with necessity of endodontic treatment in molar teeth, to be aged between 10 and 18 years; * Patients that require direct restorations in Class II MOD cavities in molar teeth; * Patients with medical history that does not compromise the evolution of the results; * Patients that have a habit of oral hygiene involving brushing teeth at least once a day; * Patients that have normal periodontal condition against the probing parameters.

Exclusion criteria

* Patients with some chronic disease with oral manifestations; * Patients who present some serious oral pathology; * Patients with no oral hygiene; * Patients with allergies to any material that will be used on this study; * Patients presenting with signs or symptoms of bruxism and dental tightening; * Patients with teeth that will be used as a pillar for removable prosthesis or fixed partial dentures; * Patients with teeth with porcelain restorations directly opposite the tooth that will receive the restoration.

Design outcomes

Primary

MeasureTime frameDescription
restoration failure2 yearsmaterial fraction

Secondary

MeasureTime frameDescription
marginal staining2 yearscolor alteration in the adhesive interface

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026