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Clinical Evaluation of Posterior Direct Restoration in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936855
Recruitment Status : Completed
First Posted : May 3, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
Coordination for the Improvement of Higher Education Personnel
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Renata Afonso da Silva Pereira, Federal University of Uberlandia

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.

Condition or disease Intervention/treatment Phase
Composite Resins Procedure: Direct composite resin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Posterior Direct Restoration in Adolescents
Actual Study Start Date : January 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2018

Arm Intervention/treatment
Active Comparator: Incremental filling technique
Glass ionomer in the pulp chamber and incremental filling technique using composite resin
Procedure: Direct 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

Experimental: Bulk Fill
Bulk fill composite resin filling all the cavity
Procedure: Direct 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




Primary Outcome Measures :
  1. restoration failure [ Time Frame: 2 years ]
    material fraction


Secondary Outcome Measures :
  1. marginal staining [ Time Frame: 2 years ]
    color alteration in the adhesive interface



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936855


Locations
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Brazil
Universidade Federal de Uberlândia
Uberlândia, Minas Gerias, Brazil, 38405320
Sponsors and Collaborators
Renata Afonso da Silva Pereira
Coordination for the Improvement of Higher Education Personnel
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Study Chair: Carlos J Soares, DDS,MS,PHD Universidade Federal de Uberlândia
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Responsible Party: Renata Afonso da Silva Pereira, PHD student, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT03936855    
Other Study ID Numbers: UFU001
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No