Composite ResinsNCT03936855

Clinical Evaluation of Posterior Direct Restoration in Adolescents

A study testing Direct composite resin in people with Composite Resins, run by Renata Afonso da Silva Pereira at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 10 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Composite Resins
What is being tested?: Direct composite resin
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteBrazil
Study dates: Jan 2016to Sep 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Universidade Federal de Uberlândia
Uberlândia, Minas Gerias, 38405320

Other trials in Brazil

About this study

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.

Read the 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.

Conditions: Composite Resins
Being tested: Direct composite resin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Direct composite resinProcedure or surgery
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

Study groups in NCT03936855
Study group	Role	What they receive
Incremental filling technique	Active comparator	Glass ionomer in the pulp chamber and incremental filling technique using composite resin Receives: Procedure: Direct composite resin
Bulk Fill	Experimental	Bulk fill composite resin filling all the cavity Receives: Procedure: Direct composite resin

What is being measured

The primary outcome is the main question the study is designed to answer.

restoration failure
material fraction
Measured: 2 years

Secondary outcomes (1)

marginal staining
color alteration in the adhesive interface
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Sep 2018

First posted3 May 2019
Study startJan 2016
Primary completionSep 2017
Study completionSep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Composite ResinsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03936855
Sponsor's protocol ID: UFU001
Status last verified: May 2019
First submitted: 1 May 2019
Last updated: 6 May 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Clinical and 3D Evaluation of Injectable Versus Conventional Composite in Class V Restorations
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Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Enrolling by invitation
Clinical Evaluation of 3D-Printed Versus Direct Composite Restorations in Class II Cavities
3D-Printed, Direct Composite
Active, not recruiting
Two-year Clinical Performance of Ion-releasing and Conventional Bulk-fill Resin Composite Restorative Systems.
Class I Dental Caries

All Composite Resins trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Posterior Direct Restoration in Adolescents
ClinicalTrials.gov ID: NCT03936855
Acronym / sponsor ID: UFU001
Conditions: Composite Resins
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Renata Afonso da Silva PereiraUniversity, hospital or other
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
Study start: Jan 2016 (actual)
Primary completion: Sep 2017 (actual)
Study completion: Sep 2018 (actual)
First posted: 3 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Incremental filling technique	Active comparator	Procedure: Direct composite resinGlass ionomer in the pulp chamber and incremental filling technique using composite resin
Bulk Fill	Experimental	Procedure: Direct composite resinBulk fill composite resin filling all the cavity

Who may qualify

Ages: 10 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Direct composite resinFor 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	Procedure or surgery	Bulk Fill, Incremental filling technique

Primary outcome

restoration failure
Time frame: 2 years
material fraction

1 secondary outcome

marginal staining
Time frame: 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
Individual participant dataSharing planned: No

Related trials for Composite Resins

Not yet recruiting
Clinical and 3D Evaluation of Injectable Versus Conventional Composite in Class V Restorations
Class V Dental Restorations
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Enrolling by invitation
Clinical Evaluation of 3D-Printed Versus Direct Composite Restorations in Class II Cavities
3D-Printed, Direct Composite
Active, not recruiting
Two-year Clinical Performance of Ion-releasing and Conventional Bulk-fill Resin Composite Restorative Systems.
Class I Dental Caries

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carlos J Soares, DDS,MS,PHD study chair

Universidade Federal de Uberlândia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Direct composite resin in people with Composite Resins, run by Renata Afonso da Silva Pereira at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

restoration failure (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03936855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.