Composite ResinNCT05432258
Nano-Hybrid vs Bulk-Fill Resin Composites
A study testing Bulk-fill composite resin and Nano-fill composite resin in people with Composite Resin and Dental Caries in Children, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the 2-year clinical performance of bulk-fill composites, which can be applied as a single layer, and the nano-hybrid filled composite resins, which are frequently used in clinical routine, in children in a split-mouth design. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Composite Resin, Dental Caries in Children
- What is being tested?
- Bulk-fill composite resin and Nano-fill composite resin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 26 Jul 2022
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Black class I or II caries on two bilateral mandibular permanent molars; clinically at score 3, 4 and 5 according to the ICDAS II (International Caries Detection and Evaluation System); and radiographically; with D2-RB4 and D3-RC5 levels
- plaque index (Silnes and Löe, 1964) scores of the teeth to be processed was 0 and 1
- the gingival index (Löe and Silness, 1963) score was 0
Who cannot join
- On the teeth to be processed; color change in the pits and fissures of the tooth, with no signs of caries after air drying for 5 seconds (ICDAS II Scale score 0), discoloration or opacity that is not visible when moist but observed after drying (ICDAS II Scale score 1), observable when both moist and dry or with opacity (ICDAS II Scale score 2), containing more than half of the tooth, with a large cavity in which dentin is observed (ICDAS II Score 6), Black class I and/or class II enamel-dentin caries,
- The values accepted in the evaluation of radiographic dental caries in the teeth for which the procedure is planned are E0-R0 (no radiolucency), E1-RA1 (radiolucency in the upper ½ of the enamel), E2-RA2 (radiolucency extending to the radiolucency-enamel-dentin junction in the lower ½ of the enamel) , with D1-RA3 (radiolucency observed in the upper 1/3 of the dentin),
- Non-antagonist of the teeth to be processed,
- In the gingival region of the teeth to be treated, there are areas covered with plaque from thin to medium thickness (plaque index score 2) and areas where the plaque thickness fills the gingival sulcus and where the soft attachment is high (plaque index score 3) (Löe and Silness, 1964),
- Bleeding and inflammation in the gingiva of the tooth to be treated (gingival index score (Löe and Silness, 1963) 1,2 and 3),
- Devitalized teeth for which the procedure is planned,
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- The patient's lack of cooperation and physician cooperation to have the procedures performed (Score 1 and 2 on the Frankl behavioral scale).
- Having any systemic disease that prevents the treatment (ASA 2,3,4,5,6)
- Patients who will not comply with their appointments will not be included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Nano-Hybrid and Bulk-Fill Resin Composites: Randomised Controlled Clinical Study
The aim of this study is to compare the 2-year clinical performance of bulk-fill composites, which can be applied as a single layer, and the nano-hybrid filled composite resins, which are frequently used in clinical routine, in children in a split-mouth design.
This study was conducted on 89 patients aged 6-12 years who had caries on bilateral mandibular first molars. Our study has a randomized, cross-controlled, and double-blind design. In split-mouth design, restorations of mandibular permanent molars completed with nano-hybrid ORMOCER based bulk-fill filling material Admira Fusion x-tra (Voco GmbH, Cuxhaven, Germany) and nano-hybrid composite Grandio (Voco , Cuxhaven, Germany). Futurabond U single dose (Voco, Cuxhaven, Germany) universal adhesive was used for all restorations, in the selective enamel etching mode. The clinical success of the restorations will be evaluated at 6, 12 and 24-month controls. Evaluations has been made by two physicians other than the one who did the restoration, who do not know which restorative material was applied to which tooth.
- Conditions
- Composite Resin, Dental Caries in Children
- Being tested
- Bulk-fill composite resin, Nano-fill composite resin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulk-fill composite resinDevice
Also called Admira Fusion x-tra (Voco GmbH, Cuxhaven, Germany)
Restoration of the mandibular first molars with bulk-fill composite resin as the manufacturer advises after the cavity preparation
Nano-fill composite resinDevice
Also called Grandio (Voco , Cuxhaven, Germany)
Restoration of the mandibular first molars with nano-fill composite resin as the manufacturer advises after the cavity preparation
| Study group | Role | What they receive |
|---|---|---|
| Bulk-fill composite resin | Experimental | Bulk-fill Ormocer composite resin restorations on the mandibular first molars applied in layers of 4 mm depth Receives: Device: Bulk-fill composite resin |
| Nano-fill composite resin | Active comparator | Nano-fill composite resin restorations on the mandibular first molars were applied in layers of 2 mm depth Receives: Device: Nano-fill composite resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of clinical performances between two restorative materials according to World Dental Federation (FDI)(1-5 scale; 1 best, 5 worst)
Change of World Dental Federation (FDI) scores of restoration from baseline to 2 year
Measured: immediately after restoration and 24 months control
Comparison of clinical performances between two restorative materials according to US Public Health Service (USPHS) criteria (Alfa-best, Bravo, Charlie-worst)
Change of the US Public Health Service (USPHS) scores of restoration from baseline to 2 year
Measured: immediately after restoration and 24 months control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start15 Jun 2020
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Composite ResinStudies 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
- Crossover
- Model description
- In a split-mouth design, 89 patients' 2 mandibular first molars were divided into 2 groups. Per patient, one mandibular first molar had bulk-fill ormocer-based composite resin restoration and 1 mandibular first molar had nanofill composite resin restoration via incremental technic.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Cagırır Dindaroglu, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432258
- Sponsor's protocol ID
- E.728477
- Status last verified
- Sep 2023
- First submitted
- 16 Jun 2022
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Nano-Hybrid and Bulk-Fill Resin Composites: Randomised Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05432258
- Acronym / sponsor ID
- E.728477
- Conditions
- Composite Resin, Dental Caries in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 27 Jun 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 this study is to compare the 2-year clinical performance of bulk-fill composites, which can be applied as a single layer, and the nano-hybrid filled composite resins, which are frequently used in clinical routine, in children in a split-mouth design.
This study was conducted on 89 patients aged 6-12 years who had caries on bilateral mandibular first molars. Our study has a randomized, cross-controlled, and double-blind design. In split-mouth design, restorations of mandibular permanent molars completed with nano-hybrid ORMOCER based bulk-fill filling material Admira Fusion x-tra (Voco GmbH, Cuxhaven, Germany) and nano-hybrid composite Grandio (Voco , Cuxhaven, Germany). Futurabond U single dose (Voco, Cuxhaven, Germany) universal adhesive was used for all restorations, in the selective enamel etching mode. The clinical success of the restorations will be evaluated at 6, 12 and 24-month controls. Evaluations has been made by two physicians other than the one who did the restoration, who do not know which restorative material was applied to which tooth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In a split-mouth design, 89 patients' 2 mandibular first molars were divided into 2 groups. Per patient, one mandibular first molar had bulk-fill ormocer-based composite resin restoration and 1 mandibular first molar had nanofill composite resin restoration via incremental technic.
| Arm | Type | Receives |
|---|---|---|
| Bulk-fill composite resin | Experimental | Device: Bulk-fill composite resinBulk-fill Ormocer composite resin restorations on the mandibular first molars applied in layers of 4 mm depth |
| Nano-fill composite resin | Active comparator | Device: Nano-fill composite resinNano-fill composite resin restorations on the mandibular first molars were applied in layers of 2 mm depth |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Black class I or II caries on two bilateral mandibular permanent molars; clinically at score 3, 4 and 5 according to the ICDAS II (International Caries Detection and Evaluation System); and radiographically; with D2-RB4 and D3-RC5 levels
- plaque index (Silnes and Löe, 1964) scores of the teeth to be processed was 0 and 1
- the gingival index (Löe and Silness, 1963) score was 0
Key exclusion criteria (9 listed)
- On the teeth to be processed; color change in the pits and fissures of the tooth, with no signs of caries after air drying for 5 seconds (ICDAS II Scale score 0), discoloration or opacity that is not visible when moist but observed after drying (ICDAS II Scale score 1), observable when both moist and dry or with opacity (ICDAS II Scale score 2), containing more than half of the tooth, with a large cavity in which dentin is observed (ICDAS II Score 6), Black class I and/or class II enamel-dentin caries,
- The values accepted in the evaluation of radiographic dental caries in the teeth for which the procedure is planned are E0-R0 (no radiolucency), E1-RA1 (radiolucency in the upper ½ of the enamel), E2-RA2 (radiolucency extending to the radiolucency-enamel-dentin junction in the lower ½ of the enamel) , with D1-RA3 (radiolucency observed in the upper 1/3 of the dentin),
- Non-antagonist of the teeth to be processed,
- In the gingival region of the teeth to be treated, there are areas covered with plaque from thin to medium thickness (plaque index score 2) and areas where the plaque thickness fills the gingival sulcus and where the soft attachment is high (plaque index score 3) (Löe and Silness, 1964),
- Bleeding and inflammation in the gingiva of the tooth to be treated (gingival index score (Löe and Silness, 1963) 1,2 and 3),
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 |
|---|---|---|
| Bulk-fill composite resinAlso: Admira Fusion x-tra (Voco GmbH, Cuxhaven, Germany)Restoration of the mandibular first molars with bulk-fill composite resin as the manufacturer advises after the cavity preparation | Device | Bulk-fill composite resin |
| Nano-fill composite resinAlso: Grandio (Voco , Cuxhaven, Germany)Restoration of the mandibular first molars with nano-fill composite resin as the manufacturer advises after the cavity preparation | Device | Nano-fill composite resin |
Primary outcome
Comparison of clinical performances between two restorative materials according to World Dental Federation (FDI)(1-5 scale; 1 best, 5 worst)
Time frame: immediately after restoration and 24 months control
Change of World Dental Federation (FDI) scores of restoration from baseline to 2 year
Comparison of clinical performances between two restorative materials according to US Public Health Service (USPHS) criteria (Alfa-best, Bravo, Charlie-worst)
Time frame: immediately after restoration and 24 months control
Change of the US Public Health Service (USPHS) scores of restoration from baseline to 2 year
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 2 Oct 2023.
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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.
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 Bulk-fill composite resin and Nano-fill composite resin in people with Composite Resin and Dental Caries in Children, run by Izmir Katip Celebi 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 3 inclusion and 9 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 2 Oct 2023. 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?
Comparison of clinical performances between two restorative materials according to World Dental Federation (FDI)(1-5 scale; 1 best, 5 worst) (time frame: immediately after restoration and 24 months control). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2023.