Clinical Evaluation of Posterior Direct Restoration in Adolescents
May 3, 2019 updated by: Renata Afonso da Silva Pereira
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minas Gerias
-
Uberlândia, Minas Gerias, Brazil, 38405320
- Universidade Federal de Uberlândia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Incremental filling technique
Glass ionomer in the pulp chamber and incremental filling technique using 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
EXPERIMENTAL GROUP
|
|
EXPERIMENTAL: Bulk Fill
Bulk fill composite resin filling all the cavity
|
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
EXPERIMENTAL GROUP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
restoration failure
Time Frame: 2 years
|
material fraction
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
marginal staining
Time Frame: 2 years
|
color alteration in the adhesive interface
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Carlos J Soares, DDS,MS,PHD, Universidade Federal de Uberlândia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2016
Primary Completion (ACTUAL)
September 1, 2017
Study Completion (ACTUAL)
September 1, 2018
Study Registration Dates
First Submitted
May 1, 2019
First Submitted That Met QC Criteria
May 1, 2019
First Posted (ACTUAL)
May 3, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 6, 2019
Last Update Submitted That Met QC Criteria
May 3, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- UFU001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.