Resin Composite RestorationsNCT06532916
Color Stability and Wear Resistance of Direct Flowable and Preheated Composite Using the Injectable Technique
A study testing Experimental: Group1: Estelite Sigma Quick and Experimental: Group 2: Estelite Flow Quick in people with Resin Composite Restorations and Esthetic Restorations, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
The aim of this study is to conduct the first clinical trial to assess the color stability and wear resistance of the highly filled injectable flowable composite materials compared to preheated conventional ones and evaluate the in vivo performance of the injectable composite technique. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resin Composite Restorations, Esthetic Restorations
- What is being tested?
- Experimental: Group1: Estelite Sigma Quick and Experimental: Group 2: Estelite Flow Quick
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteJordan
- Study dates
- 1 Mar 2014to 1 Mar 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18 years
- Asymptomatic sound anterior teeth, or localized Class III/IV/V cavity or restoration
- Patients with irregular tooth anatomies, misalignments, spacing, mild staining, cervical wear that are indicated for direct composite veneers
- Restorations in functional occlusions with an opposing natural tooth.
- Two proximal contacts area with neighboring teeth
Who cannot join
- Patients with contra-indications for regular dental treatment based on their medical history.
- Patients at a high risk of caries.
- Patients with poor oral hygiene.
- Teeth with compromised periodontal status.
- Evidence of active parafunctional habits or excessive tooth wear.
- Severe discoloration
- Heavy smokers
- Patients with special aesthetic requirements that could not be solved by direct composite veneers.
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Jordan University of Science and Technology
Irbid, P.O.Box 3030
Ghada A Maghaireh, 0798809296, gmaghair@just.edu.jo
About this study
Official title: Color Stability and Wear Resistance of Direct Flowable and Preheated Resin Composite Veneers Using the Injectable Resin Technique: A Randomized Controlled Clinical Trial.
The aim of this study is to conduct the first clinical trial to assess the color stability and wear resistance of the highly filled injectable flowable composite materials compared to preheated conventional ones and evaluate the in vivo performance of the injectable composite technique.
Read the detailed description
The design of study will be a modified split-mouth randomized clinical trial with two study groups. 20 patients will be recruited with the need of at least 6 anterior aesthetic restorations. A total of 142 restorations will be assigned into two groups. In the first group, 71 anterior teeth will be restored with flowable composite veneer restorations, and the second group 71 anterior teeth will be restored with heated composite veneer restorations. Both treatment groups will be done using the injectable resin technique. The following parameters will be evaluated at baseline, 6 months and 12 months of clinical service. Color stability will be evaluated using the Vita classical shade guide and a spectrophotometer. Wear resistance will be evaluated by measuring the volumetric material loss through superimposition of images taken at each follow up on baseline images taken by scanning of gypsum replicas using a 3D laser scanner. Clinical performance will be evaluated using the USPHS criteria. It is expected that the color stability, wear resistance and clinical performance of the heated composite restorations will be superior to the flowable restorations.
- Being tested
- Experimental: Group1: Estelite Sigma Quick, Experimental: Group 2: Estelite Flow Quick
- Keywords
- Resin composites, Injectable resins, Preheated resins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Group1: Estelite Sigma QuickOther
Preheated conventional composite (Estelite Sigma Quick, Tokuyama Dental Corp, Tokyo, Japan). Estelite Sigma Quick is a resin composite with the following composition (Silica-zirconiasupra-nano, monodispersingc spherica, Bis-GMA, UDMA, TEGDMA).
Experimental: Group 2: Estelite Flow QuickOther
Second group: Injectable flowable (Estelite Flow Quick, Tokuyama Dental Corp, Tokyo, Japan). Estelite Flow Quick is a resin composite with the following composition (Silica-zirconia, supra-nano monodispersing spherical, Bis-GMA, UDMA,TEGDMA).
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | Not described Receives: Other: Experimental: Group1: Estelite Sigma Quick; Other: Experimental: Group 2: Estelite Flow Quick |
| Group 2 | Experimental | Not described Receives: Other: Experimental: Group1: Estelite Sigma Quick; Other: Experimental: Group 2: Estelite Flow Quick |
What is being measured
The primary outcome is the main question the study is designed to answer.
The wear resistance of the injectable flowable composite veneers compared to their preheated resin composites counterparts.
Participants will be assessed at baseline, directly after the finishing and polishing procedure, and at review visits according to the following criteria:
-The gypsum replicas will be scanned three-dimensionally using a 3D laser scanner at baseline, 6 months and 12 months of clinical service, to analyse the volumetric material loss, which can be associated with structural wear, using 3D analysis software (Medit Link, Medit, Seoul, Republic of Korea) [28, 29] [30] [31] [32]. Follow up images will be superimposed on baseline images
Measured: Assessment at baseline, 6 months and 1 year after the restorations of the teeth.
The color stability of the injectable flowable composite veneers compared to their preheated resin counterparts.
-Shade measurements will be taken at baseline, one week, one month, 3 months and 6 months using the following methods:
- Using a spectrophotometer (VITA Easyshade V; VITA Zahnfabrik, Bad Säckingen, Germany), color values (L*, a*, b*) according to the Commission Internationale d'Eclairage (CIELab) will be taken at the middle of each restored tooth using a customized jig to fix the position and in the afternoon with sunlight and standardized room illumination and at each evaluation period. The color changes will be determined using the CIEDE2000 formula.
- Using Vita classical shade guide (Vita Zahnfabrik, Bad Säckingen, Germany) and a professional photograph before treatment, at baseline and at each review visit.
Measured: Assessment at baseline, 6 months and 1 year after the restorations of the teeth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Mar 2014
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resin Composite RestorationsStudies 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
- The design of the study will be a double blinded (Evaluator and Patient) split-mouth randomized clinical study with two study groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, Ghada Maghaireh, King Abdullah University Hospital
- Investigators
- Ghada A Maghaireh, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532916
- Sponsor's protocol ID
- 751-2023
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Stability and Wear Resistance of Direct Flowable and Preheated Resin Composite Veneers Using the Injectable Resin Technique: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06532916
- Acronym / sponsor ID
- 751-2023
- Keywords
- Resin composites, Injectable resins, Preheated resins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 1 Aug 2024 (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 conduct the first clinical trial to assess the color stability and wear resistance of the highly filled injectable flowable composite materials compared to preheated conventional ones and evaluate the in vivo performance of the injectable composite technique.
Detailed description
The design of study will be a modified split-mouth randomized clinical trial with two study groups. 20 patients will be recruited with the need of at least 6 anterior aesthetic restorations. A total of 142 restorations will be assigned into two groups. In the first group, 71 anterior teeth will be restored with flowable composite veneer restorations, and the second group 71 anterior teeth will be restored with heated composite veneer restorations. Both treatment groups will be done using the injectable resin technique. The following parameters will be evaluated at baseline, 6 months and 12 months of clinical service. Color stability will be evaluated using the Vita classical shade guide and a spectrophotometer. Wear resistance will be evaluated by measuring the volumetric material loss through superimposition of images taken at each follow up on baseline images taken by scanning of gypsum replicas using a 3D laser scanner. Clinical performance will be evaluated using the USPHS criteria. It is expected that the color stability, wear resistance and clinical performance of the heated composite restorations will be superior to the flowable restorations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The design of the study will be a double blinded (Evaluator and Patient) split-mouth randomized clinical study with two study groups.
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Other: Experimental: Group1: Estelite Sigma Quick, Other: Experimental: Group 2: Estelite Flow Quick |
| Group 2 | Experimental | Other: Experimental: Group1: Estelite Sigma Quick, Other: Experimental: Group 2: Estelite Flow Quick |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 18 years
- Asymptomatic sound anterior teeth, or localized Class III/IV/V cavity or restoration
- Patients with irregular tooth anatomies, misalignments, spacing, mild staining, cervical wear that are indicated for direct composite veneers
- Restorations in functional occlusions with an opposing natural tooth.
- Two proximal contacts area with neighboring teeth
Key exclusion criteria (8 listed)
- Patients with contra-indications for regular dental treatment based on their medical history.
- Patients at a high risk of caries.
- Patients with poor oral hygiene.
- Teeth with compromised periodontal status.
- Evidence of active parafunctional habits or excessive tooth wear.
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 |
|---|---|---|
| Experimental: Group1: Estelite Sigma QuickPreheated conventional composite (Estelite Sigma Quick, Tokuyama Dental Corp, Tokyo, Japan). Estelite Sigma Quick is a resin composite with the following composition (Silica-zirconiasupra-nano, monodispersingc spherica, Bis-GMA, UDMA, TEGDMA). | Other | Group 2, Group1 |
| Experimental: Group 2: Estelite Flow QuickSecond group: Injectable flowable (Estelite Flow Quick, Tokuyama Dental Corp, Tokyo, Japan). Estelite Flow Quick is a resin composite with the following composition (Silica-zirconia, supra-nano monodispersing spherical, Bis-GMA, UDMA,TEGDMA). | Other | Group 2, Group1 |
Primary outcome
The wear resistance of the injectable flowable composite veneers compared to their preheated resin composites counterparts.
Time frame: Assessment at baseline, 6 months and 1 year after the restorations of the teeth.
Participants will be assessed at baseline, directly after the finishing and polishing procedure, and at review visits according to the following criteria: -The gypsum replicas will be scanned three-dimensionally using a 3D laser scanner at baseline, 6 months and 12 months of clinical service, to analyse the volumetric material loss, which can be associated with structural wear, using 3D analysis software (Medit Link, Medit, Seoul, Republic of Korea) [28, 29] [30] [31] [32]. Follow up images will be superimposed on baseline images
The color stability of the injectable flowable composite veneers compared to their preheated resin counterparts.
Time frame: Assessment at baseline, 6 months and 1 year after the restorations of the teeth.
-Shade measurements will be taken at baseline, one week, one month, 3 months and 6 months using the following methods: 1. Using a spectrophotometer (VITA Easyshade V; VITA Zahnfabrik, Bad Säckingen, Germany), color values (L*, a*, b*) according to the Commission Internationale d'Eclairage (CIELab) will be taken at the middle of each restored tooth using a customized jig to fix the position and in the afternoon with sunlight and standardized room illumination and at each evaluation period. The color changes will be determined using the CIEDE2000 formula. 2. Using Vita classical shade guide (Vita Zahnfabrik, Bad Säckingen, Germany) and a professional photograph before treatment, at baseline and at each review visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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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.
Ghada A Maghaireh principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Group1: Estelite Sigma Quick and Experimental: Group 2: Estelite Flow Quick in people with Resin Composite Restorations and Esthetic Restorations, run by King Abdullah University Hospital at 1 site in Jordan.
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 8 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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 Jordan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghada A Maghaireh (0798809296, gmaghair@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The wear resistance of the injectable flowable composite veneers compared to their preheated resin composites counterparts. (time frame: Assessment at baseline, 6 months and 1 year after the restorations of the teeth.). 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 6 Aug 2024.