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.
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.
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.
- Conditions
- Proximal Cavities of Posterior Teeth
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Injectable Universal flowable resin composite Receives: Other: PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan (super low flowability) |
| Control | Active comparator | Conventional 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.
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.
- First posted2 Mar 2022
- Study start1 Apr 2022
- Primary completion2 Apr 2023
- Study completion2 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Proximal Cavities of Posterior TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nanees Ayman Hassan Aly, Cairo University
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 26266238Bayraktar 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 26800647Ferracane 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 33206440Frascino 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 31034347Irmak 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 29081447Imai 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 30265868Ikeda 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 20019418Jang 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 25136904Kramer 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 26525008Kitasako 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 26573239Lai 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 29998939Loguercio 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 26158415Stape 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 29913306Shaalan 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 29430087Stefanski 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Injectable Universal Flowable Composite Versus Conventional Resin Composite Restorations in Proximal Cavities of Posterior Teeth.
- ClinicalTrials.gov ID
- NCT05263089
- Acronym / sponsor ID
- Universal flowable composite
- Conditions
- Proximal Cavities of Posterior Teeth
- Keywords
- Injectable universal flowable composite, Conventional resin composite, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 2 Apr 2023 (actual)
- Study completion
- 2 Apr 2023 (actual)
- First posted
- 2 Mar 2022 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan (super low flowability)Injectable Universal flowable resin composite |
| Control | Active comparator | Other: ESTELITE® Alpha; Tokuyama, Tokyo, JapanConventional resin composite |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan (super low flowability)Also: Injectable Universal flowable resin compositeSupplied 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. | Other | Intervention |
| ESTELITE® Alpha; Tokuyama, Tokyo, JapanAlso: Conventional resin compositeThe composite was inserted using the incremental technique. Each increment of 2 mm was cured for 40 s. | Other | Control |
Primary outcome
Criteria of restoration evaluation indicating clinical performance.
Time frame: 12 months
The restoration will be evaluated for any fracture or loss of retention by using prob following Modified USPHS criteria.
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 12 Feb 2025.
- Background: PubMed 26266238Baroudi 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.
- Background: PubMed 26800647Bayraktar 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.
- Background: PubMed 33206440Ferracane 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.
- Background: PubMed 31034347Frascino 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.
- Background: PubMed 29081447Irmak 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.
- Background: PubMed 30265868Imai 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.
- Background: PubMed 20019418Ikeda 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.
- Background: PubMed 25136904Jang 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.
- Background: PubMed 26525008Kramer 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.
- Background: PubMed 26573239Kitasako 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.
- Background: PubMed 29998939Lai 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.
- Background: PubMed 26158415Loguercio 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.
- Individual participant dataSharing planned: No
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Proximal Cavities of Posterior Teeth
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.