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Proximal Cavities of Posterior TeethNCT05263089

Clinical Performance of Injectable Universal Flowable Composite in Proximal Cavities of Posterior Teeth.

A study testing PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan (super low flowability) and ESTELITE® Alpha; Tokuyama, Tokyo, Japan in people with Proximal Cavities of Posterior Teeth, run by Cairo University at 1 site in Egypt.

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

The aim of the study is to evaluate the clinical performance of injectable universal flowable composite vs conventional resin composite restorations in proximal cavities of posterior teeth. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Proximal Cavities of Posterior Teeth
What is being tested?
PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan (super low flowability) and ESTELITE® Alpha; Tokuyama, Tokyo, Japan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
1 Apr 2022to 2 Apr 2023
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Participant Inclusion Criteria

  • Adult patients aged 18-55 years.
  • Patients with good oral hygiene (mild to moderate plaque accumulation).
  • patients with asymptomatic compound proximal cavities in permanent posterior teeth.
  • ICDAS (3 \&4)

Teeth inclusion criteria

  • Vital posterior teeth with compound proximal cavities.
  • Teeth with no or minimum mobility
  • No history of hypersensitivity in the teeth to be restored
  • Free from signs and symptoms of pulpitis and pulpal necrosis.

Participant Exclusion criteria

  • Patients who are unable to return for recall appointments.
  • Patients with poor oral hygiene.
  • Presence of abnormal oral, medical, or mental condition
  • Patients with untreated extra occlusal stresses
  • Patients with TMJ problems.

Teeth Exclusion criteria

  • Root involvement.
  • Periodontal disease that may affect the prognosis of the restoration or the tooth itself.
  • Fractured or visibly cracked teeth.
  • Presence of any developmental or formative defects.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo university

    Cairo

Other trials in Egypt

About this study

Official title: Clinical Performance of Injectable Universal Flowable Composite Versus Conventional Resin Composite Restorations in Proximal Cavities of Posterior Teeth.

The aim of the study is to evaluate the clinical performance of injectable universal flowable composite vs conventional resin composite restorations in proximal cavities of posterior teeth. The null hypothesis is proposed that there will be no difference in the clinical performance of injectable universal flowable composite versus conventional resin composite restorations in proximal cavities of posterior teeth. The design for this randomized controlled clinical trial is a superiority framework with parallel groups with equal allocation ratios. The patients are randomly divided into two groups where one group will receive conventional resin composite and the other group will receive injectable universal flowable resin composite. The restorations will be evaluated for any fracture or loss of retention by using prob following Modified USPHS criteria at baseline, 3, 6, 12 month.

Read the detailed description

The study will be conducted in the Conservative Dentistry Department, Faculty of Dentistry, Cairo University in conjunction with the Conservative Dentistry Department, Faculty of Dentistry, MSA University outpatient clinics. The predicted sample size was a total of 24. The sample size was increased by (20%) to account for possible dropouts during follow-up intervals to be total of (30) cases i.e. (15) for each group. Screening of patients that come to the Conservative Dentistry Department seeking dental care will continue until the target population is achieved. The patients will be subjected to examination and diagnosis. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research operator who will explain the study and ascertain the patients' interest. If interested, more detailed evaluations and preparations, and schedule planning will be made. Then the patient will sign the informed consent to ensure the approval for all the prosecuted that will be done and his/her acceptance to participate in this trial. Randomization will be done using simple randomization by computerized sequence generation using www.random.org by generating numbers from 1:30 into two columns. Each participant will choose a random number from an opaque sealed envelope. When the participant chooses an envelope, it will be signed by the patient and the supervisor and the number on the envelope will be recorded in the patient chart to ensure that the patient is assigned to the randomized group. After anesthesia, prophylaxis was performed using a brush associated with pumice, mounted in a low-speed handpiece. The teeth will be cleaned from any plaque or debris. After shade selection, rubber dam isolation will be used to avoid any moisture contamination which might affect the clinical performance of the bond and restoration, and to provide favorable conditions for bond application, if any reason is found that contraindicate rubber dam usage the procedure will be done under the cotton roll and high suction insulation and the use of retraction cord if needed to avoid any moisture contamination. The class II preparations will be made with spherical diamond burs of appropriate size and removal of carious dentine will be performed with spherical carbide bur at low-speed hand-piece and hand instruments. The cavities were designed according to the principles of minimally invasive dentistry. The outline shape of the preparations will be limited to the removal of caries. No bevels were prepared. Minor finishing and polishing may be done to the teeth if needed to remove any sharp edges or friable/undermined enamel. PALFIQUE BOND (Palfique, Tokuyama, Japan) will be used with both types of resin composites to ensure standardization of the procedures. It is a one-component, one-coat application, self-etching, light-cured, dental adhesive system. By using the disposable applicator, the bond will be applied on the surface of the prepared cavity and then wait for 10 seconds or more. Then mild air is continuously applied to the surface for 5 seconds until the runny bond stays in the same position without any movement and light-cured for 10 seconds. Injectable Universal flowable resin composite (PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan) super-low flowability supplied in L-syringe with nozzle and dispensing Tips. "Super Low" has low flowability, non-slumping, non-running, and precision stacking properties. The layer dispensed will be 2 mm. in thickness and cured for 40 s. Conventional resin composite (ESTELITE® Alpha; Tokuyama, Tokyo, Japan). The composite was inserted using the incremental technique. Incremental filling techniques result in better light penetration and better polymerization of the composite resin, reduction of the cavity configuration factor, cuspal deflection, polymerization shrinkage stresses; and ensures that the resin adheres better to cavity walls. Each increment of 2 mm was cured for 40 s.

The restoration was performed for both groups using a pre-curved metallic sectional matrix, associated with a separating ring and a wooden wedge.

Following the removal of the matrix band, the proximal regions of the restorations were additionally polymerized buccally and lingually/palatally for 10 s.

Occlusal adjustments were made using articulating paper, and the quality of the interproximal contacts and cervical adaptation was checked by means of dental floss and interproximal radiographs. The restorations were finished with water-cooled fine and super-fine diamond burs. The polishing procedures of the occlusal surface were performed with abrasive rubber tips during the same appointment immediately after the restorative procedure for both groups. All participants will be instructed to follow oral hygiene measures to avoid plaque and bacterial accumulation which may negatively affect the clinical performance as fracture or loss of retention. The restoration will be evaluated for any fracture or loss of retention by using prob following Modified USPHS criteria.

Being tested
PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan (super low flowability), ESTELITE® Alpha; Tokuyama, Tokyo, Japan
Keywords
Injectable universal flowable composite, Conventional resin composite, Randomized clinical trial

What participants receive

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

  • PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan (super low flowability)Other

    Also called Injectable Universal flowable resin composite

    Supplied in L-syringe with nozzle and dispensing Tips. "Super Low" has low flowability, non-slumping, non-running, and precision stacking properties. The layer dispensed will be 2 mm. in thickness and cured for 40 s.

  • ESTELITE® Alpha; Tokuyama, Tokyo, JapanOther

    Also called Conventional resin composite

    The composite was inserted using the incremental technique. Each increment of 2 mm was cured for 40 s.

Study groups in NCT05263089
Study groupRoleWhat they receive
InterventionExperimentalInjectable Universal flowable resin composite
Receives: Other: PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan (super low flowability)
ControlActive comparatorConventional resin composite
Receives: Other: ESTELITE® Alpha; Tokuyama, Tokyo, Japan

What is being measured

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

  1. Criteria of restoration evaluation indicating clinical performance.

    The restoration will be evaluated for any fracture or loss of retention by using prob following Modified USPHS criteria.

    Measured: 12 months

Timeline

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

  1. First posted2 Mar 2022
  2. Study start1 Apr 2022
  3. Primary completion2 Apr 2023
  4. Study completion2 Apr 2023

Resources

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05263089
Sponsor's protocol ID
Universal flowable composite
Status last verified
Feb 2025
First submitted
11 Feb 2022
Last updated
12 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baroudi K, Rodrigues JC. Flowable Resin Composites: A Systematic Review and Clinical Considerations. J Clin Diagn Res. 2015 Jun;9(6):ZE18-24. doi: 10.7860/JCDR/2015/12294.6129. Epub 2015 Jun 1.

    PubMed 26266238
  • Bayraktar Y, Ercan E, Hamidi MM, Colak H. One-year clinical evaluation of different types of bulk-fill composites. J Investig Clin Dent. 2017 May;8(2). doi: 10.1111/jicd.12210. Epub 2016 Jan 22.

    PubMed 26800647
  • Ferracane JL, Lawson NC. Probing the hierarchy of evidence to identify the best strategy for placing class II dental composite restorations using current materials. J Esthet Restor Dent. 2021 Jan;33(1):39-50. doi: 10.1111/jerd.12686. Epub 2020 Nov 18.

    PubMed 33206440
  • Frascino S, Fagundes TC, Silva U, Rahal V, Barboza A, Santos PH, Briso A. Randomized Prospective Clinical Trial of Class II Restorations Using Low-shrinkage Flowable Resin Composite. Oper Dent. 2020 Jan/Feb;45(1):19-29. doi: 10.2341/18-230-C. Epub 2019 Apr 29.

    PubMed 31034347
  • Irmak O, Yaman BC, Orhan EO, Ozer F, Blatz MB. Effect of rubbing force magnitude on bond strength of universal adhesives applied in self-etch mode. Dent Mater J. 2018 Jan 30;37(1):139-145. doi: 10.4012/dmj.2017-018. Epub 2017 Oct 27.

    PubMed 29081447
  • Imai A, Takamizawa T, Sugimura R, Tsujimoto A, Ishii R, Kawazu M, Saito T, Miyazaki M. Interrelation among the handling, mechanical, and wear properties of the newly developed flowable resin composites. J Mech Behav Biomed Mater. 2019 Jan;89:72-80. doi: 10.1016/j.jmbbm.2018.09.019. Epub 2018 Sep 17.

    PubMed 30265868
  • Ikeda I, Otsuki M, Sadr A, Nomura T, Kishikawa R, Tagami J. Effect of filler content of flowable composites on resin-cavity interface. Dent Mater J. 2009 Nov;28(6):679-85. doi: 10.4012/dmj.28.679.

    PubMed 20019418
  • Jang JH, Park SH, Hwang IN. Polymerization shrinkage and depth of cure of bulk-fill resin composites and highly filled flowable resin. Oper Dent. 2015 Mar-Apr;40(2):172-80. doi: 10.2341/13-307-L. Epub 2014 Aug 19.

    PubMed 25136904
  • Kramer N, Reinelt C, Frankenberger R. Ten-year Clinical Performance of Posterior Resin Composite Restorations. J Adhes Dent. 2015 Aug;17(5):433-41. doi: 10.3290/j.jad.a35010.

    PubMed 26525008
  • Kitasako Y, Sadr A, Burrow MF, Tagami J. Thirty-six month clinical evaluation of a highly filled flowable composite for direct posterior restorations. Aust Dent J. 2016 Sep;61(3):366-73. doi: 10.1111/adj.12387.

    PubMed 26573239
  • Lai G, Zhao L, Wang J, Kunzelmann KH. Surface properties and color stability of dental flowable composites influenced by simulated toothbrushing. Dent Mater J. 2018 Sep 30;37(5):717-724. doi: 10.4012/dmj.2017-233. Epub 2018 Jul 12.

    PubMed 29998939
  • Loguercio AD, Luque-Martinez I, Lisboa AH, Higashi C, Queiroz VA, Rego RO, Reis A. Influence of Isolation Method of the Operative Field on Gingival Damage, Patients' Preference, and Restoration Retention in Noncarious Cervical Lesions. Oper Dent. 2015 Nov-Dec;40(6):581-93. doi: 10.2341/14-089-C. Epub 2015 Jul 9.

    PubMed 26158415
  • Stape THS, Wik P, Mutluay MM, Al-Ani AAS, Tezvergil-Mutluay A. Selective dentin etching: A potential method to improve bonding effectiveness of universal adhesives. J Mech Behav Biomed Mater. 2018 Oct;86:14-22. doi: 10.1016/j.jmbbm.2018.06.015. Epub 2018 Jun 8.

    PubMed 29913306
  • Shaalan OO, Abou-Auf E, El Zoghby AF. Clinical evaluation of flowable resin composite versus conventional resin composite in carious and noncarious lesions: Systematic review and meta-analysis. J Conserv Dent. 2017 Nov-Dec;20(6):380-385. doi: 10.4103/JCD.JCD_226_17.

    PubMed 29430087
  • Stefanski S, van Dijken JW. Clinical performance of a nanofilled resin composite with and without an intermediary layer of flowable composite: a 2-year evaluation. Clin Oral Investig. 2012 Feb;16(1):147-53. doi: 10.1007/s00784-010-0485-8. Epub 2010 Nov 23.

    PubMed 21104100

Questions about this trial

What is this clinical trial studying?

A study testing PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan (super low flowability) and ESTELITE® Alpha; Tokuyama, Tokyo, Japan in people with Proximal Cavities of Posterior Teeth, run by Cairo University at 1 site in Egypt.

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

Who may be eligible to take part?

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 12 Feb 2025. 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 Egypt. 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?

Criteria of restoration evaluation indicating clinical performance. (time frame: 12 months). 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 NCT05263089, which also lists 21 linked publications.

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 12 Feb 2025.

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