Dental Caries Extending Into DentinNCT04612543
Clinical Evaluation of Extensive Direct Composite Restorations With Polyethylene Fiber
A study testing Genial Posterior Composite with Polyethylene Fiber and Genial Posterior Composite in people with Dental Caries Extending Into Dentin, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial was to compare the clinical performances of composite resin restorations with/without the polyethylene fiber to the first permanent molar teeth with extensively carious pediatric patients. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Extending Into Dentin
- What is being tested?
- Genial Posterior Composite with Polyethylene Fiber and Genial Posterior Composite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2019to 31 Aug 2020
- 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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- no hypoplasia or any tissue abnormality in the teeth,
- deep dentin caries with three tubercle loss in the teeth, need of three surface restorations with coverage of at least two adjacent cusps.
- no evidence for pulpal complications
- in occlusion
Who cannot join
- partly erupted teeth;
- -.absence of adjacent and antagonist teeth
- poor periodontal status;
- adverse medical history;
- potential behavioral problems.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kafkas University School of Dentistry
Kars, 36000
About this study
Official title: Randomized, Controlled Clinical Evaluation of Extensive Direct Composite Restorations With Polyethylene Fiber in the First Permanent Molars of Children
The aim of this clinical trial was to compare the clinical performances of composite resin restorations with/without the polyethylene fiber to the first permanent molar teeth with extensively carious pediatric patients. A total of 75 restorations with (FC; n=38)or without (C; n=37) fiber were placed in the first permanent molar teeth.
Restorations were evaluated at baseline-6-12-18 months according to the modified-USPHS criteria. Data were analyzed with Chi-Square and Cochran's Q (p<0.05).
Read the detailed description
Fiber reinforced composite restorations developed in recent years have been presented to improve the negative properties of composite resin systems applied by the traditional method thanks to the fact that the fibers act as a crack stopper, reduce polymerization shrinkage by decreasing the the mass of composite resin material between the remaining dentin structure and the fiber. Many authors having conducted tremendous experience in this field of research have reported that the polyethylene fiber is an innovative approach because it not only increases the flexural strength but also improves fracture toughness. Its woven fiber orientation provides the stresses to be dispersed throughout the restoration, and therefore reinforces the restoration and the remaining tooth structure in multiple directions.
- Conditions
- Dental Caries Extending Into Dentin
- Being tested
- Genial Posterior Composite with Polyethylene Fiber, Genial Posterior Composite
- Keywords
- Composite resin, Clinical Evaluation, Polyethylene Fiber, First Permanent Molars, Extensive carious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genial Posterior Composite with Polyethylene FiberDevice
Also called Micro hybrid composite with Polyethylene Fiber
Placing restorations,Genial Posterior Composite with Polyethylene Fiber, after bonding procedures, remaining tooth composite resin walls were created and cured for 20 s. Prepared ribbond fiber pieces, 2-mm-wide approximately 12mm-long, (Ribbond Thinner, Higher, Modulus, Ribbond Inc,Seattle) were wetted with an unfilled resin for 2 minutes at a non-light environment. The inner surfaces of the prepared class I cavity were lined with flowable resin. After removing the excess resin, pre-wetted polyethylene fiber was condensed circumferentially and embedded with a hand instrument into the bed of unpolymerized flowable composite and then polymerized for 20 seconds with Light Emitting Diodes. After curing for 20 s, composite resin was applied to the rest of the cavity incrementally, each increment was cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.
Genial Posterior CompositeDevice
Also called Micro hybrid composite
Placing Genial Posterior Composite, the enamel and dentin were conditioned with bonding procedure using an applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Genial Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments
| Study group | Role | What they receive |
|---|---|---|
| Genial Posterior Composite with Polyethylene fiber | Active comparator | The enamel and dentin were conditioned with bonding procedure.After bonding procedures, remaining tooth composite resin walls were created and cured for 20 s. Prepared ribbond fiber pieces, 2-mm-wide approximately 12mm-long, (Ribbond Thinner, Higher, Modulus - Ribbond Inc,Seattle) were wetted with an unfilled resin for 2 minutes at a non-light environment. The inner surfaces of the prepared class I cavity were lined with flowable resin. After removing the excess resin, pre-wetted polyethylene fiber was condensed circumferentially and embedded with a hand instrument into the bed of unpolymerized flowable composite and then polymerized for 20 seconds with Light Emitting Diodes. After curing for 20 s, composite resin was applied to the rest of the cavity incrementally, each increment was cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments. Receives: Device: Genial Posterior Composite with Polyethylene Fiber; Device: Genial Posterior Composite |
| Genial Posterior Composite | Active comparator | The enamel and dentin were conditioned with bonding procedure using an applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Genial Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments Receives: Device: Genial Posterior Composite with Polyethylene Fiber; Device: Genial Posterior Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Observers evaluated the restorations was performed using the modified United State Public Health Service criteria which was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed. A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap with discoloration (removable)
Measured: From baseline to 18 months the change of restorations was evaluated
marginal discoloration
Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction
Measured: From baseline to 18 months the change of restorations was evaluated
retention rate
Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed
Measured: From baseline to 18 months the change of restorations was evaluated
anatomic form
Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.
Measured: From baseline to 18 months the change of restorations was evaluated
color change
Alpha: The restoration matches the adjacent tooth structure in color and translucency.
Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency
Alpha: The restoration matches the adjacent tooth structure in color and translucency.
Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency
Measured: From baseline to 18 months the change of restorations was evaluated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start10 Feb 2019
- Primary completion10 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental Caries Extending Into DentinStudies 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
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semanur Özüdoğru, Kafkas University
- Investigators
- SEMANUR ÖZÜDOĞRU, Ass.. Prof, Study director, Kafkas University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612543
- Sponsor's protocol ID
- KafkasU
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Deliperi S, Alleman D, Rudo D. Stress-reduced Direct Composites for the Restoration of Structurally Compromised Teeth: Fiber Design According to the "Wallpapering" Technique. Oper Dent. 2017 May/Jun;42(3):233-243. doi: 10.2341/15-289-T.
PubMed 28467261Candan U, Eronat N, Oncag O. Clinical performance of fiber-reinforced nanofilled resin composite in extensively carious posterior teeth of children: 30-month evaluation. J Clin Pediatr Dent. 2013 Fall;38(1):1-6. doi: 10.17796/jcpd.38.1.q352786473372282.
PubMed 24579274Garoushi S, Lassila LV, Tezvergil A, Vallittu PK. Static and fatigue compression test for particulate filler composite resin with fiber-reinforced composite substructure. Dent Mater. 2007 Jan;23(1):17-23. doi: 10.1016/j.dental.2005.11.041. Epub 2006 Jan 18.
PubMed 16414110
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Clinical Evaluation of Extensive Direct Composite Restorations With Polyethylene Fiber in the First Permanent Molars of Children
- ClinicalTrials.gov ID
- NCT04612543
- Acronym / sponsor ID
- KafkasU
- Conditions
- Dental Caries Extending Into Dentin
- Keywords
- Composite resin, Clinical Evaluation, Polyethylene Fiber, First Permanent Molars, Extensive carious
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 3 Nov 2020 (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 this clinical trial was to compare the clinical performances of composite resin restorations with/without the polyethylene fiber to the first permanent molar teeth with extensively carious pediatric patients. A total of 75 restorations with (FC; n=38)or without (C; n=37) fiber were placed in the first permanent molar teeth.
Restorations were evaluated at baseline-6-12-18 months according to the modified-USPHS criteria. Data were analyzed with Chi-Square and Cochran's Q (p<0.05).
Detailed description
Fiber reinforced composite restorations developed in recent years have been presented to improve the negative properties of composite resin systems applied by the traditional method thanks to the fact that the fibers act as a crack stopper, reduce polymerization shrinkage by decreasing the the mass of composite resin material between the remaining dentin structure and the fiber. Many authors having conducted tremendous experience in this field of research have reported that the polyethylene fiber is an innovative approach because it not only increases the flexural strength but also improves fracture toughness. Its woven fiber orientation provides the stresses to be dispersed throughout the restoration, and therefore reinforces the restoration and the remaining tooth structure in multiple directions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Genial Posterior Composite with Polyethylene fiber | Active comparator | Device: Genial Posterior Composite with Polyethylene Fiber, Device: Genial Posterior CompositeThe enamel and dentin were conditioned with bonding procedure.After bonding procedures, remaining tooth composite resin walls were created and cured for 20 s. Prepared ribbond fiber pieces, 2-mm-wide approximately 12mm-long, (Ribbond Thinner, Higher, Modulus - Ribbond Inc,Seattle) were wetted with an unfilled resin for 2 minutes at a non-light environment. The inner surfaces of the prepared class I cavity were lined with flowable resin. After removing the excess resin, pre-wetted polyethylene fiber was condensed circumferentially and embedded with a hand instrument into the bed of unpolymerized flowable composite and then polymerized for 20 seconds with Light Emitting Diodes. After curing for 20 s, composite resin was applied to the rest of the cavity incrementally, each increment was cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments. |
| Genial Posterior Composite | Active comparator | Device: Genial Posterior Composite with Polyethylene Fiber, Device: Genial Posterior CompositeThe enamel and dentin were conditioned with bonding procedure using an applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Genial Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- no hypoplasia or any tissue abnormality in the teeth,
- deep dentin caries with three tubercle loss in the teeth, need of three surface restorations with coverage of at least two adjacent cusps.
- no evidence for pulpal complications
- in occlusion
Key exclusion criteria (5 listed)
- partly erupted teeth;
- -.absence of adjacent and antagonist teeth
- poor periodontal status;
- adverse medical history;
- potential behavioral problems.
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 |
|---|---|---|
| Genial Posterior Composite with Polyethylene FiberAlso: Micro hybrid composite with Polyethylene FiberPlacing restorations,Genial Posterior Composite with Polyethylene Fiber, after bonding procedures, remaining tooth composite resin walls were created and cured for 20 s. Prepared ribbond fiber pieces, 2-mm-wide approximately 12mm-long, (Ribbond Thinner, Higher, Modulus, Ribbond Inc,Seattle) were wetted with an unfilled resin for 2 minutes at a non-light environment. The inner surfaces of the prepared class I cavity were lined with flowable resin. After removing the excess resin, pre-wetted polyethylene fiber was condensed circumferentially and embedded with a hand instrument into the bed of unpolymerized flowable composite and then polymerized for 20 seconds with Light Emitting Diodes. After curing for 20 s, composite resin was applied to the rest of the cavity incrementally, each increment was cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments. | Device | Genial Posterior Composite, Genial Posterior Composite with Polyethylene fiber |
| Genial Posterior CompositeAlso: Micro hybrid compositePlacing Genial Posterior Composite, the enamel and dentin were conditioned with bonding procedure using an applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Genial Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments | Device | Genial Posterior Composite, Genial Posterior Composite with Polyethylene fiber |
Primary outcome
Marginal adaptation
Time frame: From baseline to 18 months the change of restorations was evaluated
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Observers evaluated the restorations was performed using the modified United State Public Health Service criteria which was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed. A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap with discoloration (removable)
marginal discoloration
Time frame: From baseline to 18 months the change of restorations was evaluated
Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction
retention rate
Time frame: From baseline to 18 months the change of restorations was evaluated
Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed
anatomic form
Time frame: From baseline to 18 months the change of restorations was evaluated
Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.
color change
Time frame: From baseline to 18 months the change of restorations was evaluated
Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency
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 3 Nov 2020.
- Background: PubMed 28467261Deliperi S, Alleman D, Rudo D. Stress-reduced Direct Composites for the Restoration of Structurally Compromised Teeth: Fiber Design According to the "Wallpapering" Technique. Oper Dent. 2017 May/Jun;42(3):233-243. doi: 10.2341/15-289-T.
- Background: PubMed 24579274Candan U, Eronat N, Oncag O. Clinical performance of fiber-reinforced nanofilled resin composite in extensively carious posterior teeth of children: 30-month evaluation. J Clin Pediatr Dent. 2013 Fall;38(1):1-6. doi: 10.17796/jcpd.38.1.q352786473372282.
- Background: PubMed 16414110Garoushi S, Lassila LV, Tezvergil A, Vallittu PK. Static and fatigue compression test for particulate filler composite resin with fiber-reinforced composite substructure. Dent Mater. 2007 Jan;23(1):17-23. doi: 10.1016/j.dental.2005.11.041. Epub 2006 Jan 18.
- Individual participant dataSharing planned: Yes
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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.
SEMANUR ÖZÜDOĞRU, Ass.. Prof study director
Kafkas University School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genial Posterior Composite with Polyethylene Fiber and Genial Posterior Composite in people with Dental Caries Extending Into Dentin, run by Kafkas University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 3 Nov 2020. 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 Turkey (Türkiye). 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?
Marginal adaptation (time frame: From baseline to 18 months the change of restorations was evaluated). The study lists 5 primary outcomes in all. 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 NCT04612543, which also lists 3 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 3 Nov 2020.