Caries Class IINCT05949502
Evaluation of Performance and Occlusal Wear of Low Shrinkage Giomer Compared to Nanohybrid Resin Composite
A study testing Beautifil II LS (Low-Shrinkage) and 3M Filtek Z250 XT Universal in people with Caries Class II, run by Cairo University.
Trial summary
A clinical trial, comparing the clinical performance and occlusal wear resistance of two different restorative materials in restoring proximal caries in permanent posterior teeth. One is based on giomer technology and the other is nano-hybrid resin composite. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Class II
- What is being tested?
- Beautifil II LS (Low-Shrinkage) and 3M Filtek Z250 XT Universal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Feb 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 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient's age ranging from 19-30
- Good oral hygiene.
- Patients who have stable occlusion.
- Patients who could be present for further periodic follow-ups.
- Possibility for application of rubber dam during restoration.
- Patient compliance.
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- Vital first and second molars, with compound Class II lesions.
- The selected teeth should be in occlusion with natural dentition and having proximal contact with adjacent teeth.
- Healthy periodontium.
Who cannot join
- Poor oral hygiene.
- Patients with high caries index or high plaque index.
- Patients with periodontal problems.
- Heavy bruxism habit or presence of any parafunctional habits.
- Any allergic reactions against any components of the materials to be used in the study.
- History of severe medical complications such as xerostomia.
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- Pregnant or lactating women.
- Participating in another clinical trial.
- Fractured or evidently cracked teeth.
- Defective restorations adjacent or opposite the selected tooth for research.
- Atypical extrinsic staining of teeth.
- Teeth with defects or lesions requiring other operative interventions.
- Teeth with pulpal pain.
- Teeth with periapical lesions.
- Root Canal treated teeth.
- Mobile Teeth.
- Non-functioning teeth with no opposing tooth.
- Signs of severe attrition.
- Heavy occlusion.
- Periodontally affected teeth.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Performance and Occlusal Wear of Low Shrinkage Giomer Compared to Nanohybrid Resin Composite in Proximal Restorations After Two Years: A Randomized Clinical Trial.
A clinical trial, comparing the clinical performance and occlusal wear resistance of two different restorative materials in restoring proximal caries in permanent posterior teeth. One is based on giomer technology and the other is nano-hybrid resin composite.
Read the detailed description
The aim of this study is to assess clinical performance and occlusal wear resistance of low shrinkage Giomer and Nanohybrid Resin Composite in proximal restorations using revised FDI (World Dental Federation) criteria and digital intra-oral scanner.
Two different restorative materials will be evaluated after two years for fracture, retention and occlusal wear. Furthermore, the rest of the revised FDI Criteria including functional (marginal adaptation, proximal contact point, form and contour, occlusion and occlusal wear) , biological (caries at restoration margin (CAR), dental hard tissue defects at restoration margin and postoperative hypersensitivity/pulp status) and esthetic properties (surface luster and surface texture, marginal staining and color match) will be also evaluated.
The first material is based on the giomer technology which is a true hybrid between nano-hybrid resin composite and glass ionomer. The comparator will be a nano-hybrid resin composite.
Examination and selection of all patients will be done. Teeth with proximal, primary carious lesions will be selected. Rubber dam isolation will be done followed by preparation of Class II cavities and placement of restorative material according to the randomization sequence.
Low-shrinkage bioactive material will be applied according to the manufacturer's instructions. For the comparator group, nano-hybrid resin composite will be also applied according to the manufacturer's instructions. Restorations will evaluated at baseline, after six, 12, 18 and 24 months.
- Conditions
- Caries Class II
- Being tested
- Beautifil II LS (Low-Shrinkage), 3M Filtek Z250 XT Universal
- Keywords
- Low-shrinkage Giomer, Nano-hybrid composite, Revised FDI criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beautifil II LS (Low-Shrinkage)Drug
Also called low shrinkage Giomer
low shrinkage bioactive material Giomer
3M Filtek Z250 XT UniversalDrug
Also called Nano-hybrid composite
Universal Nano-hybrid composite
| Study group | Role | What they receive |
|---|---|---|
| Low shrinkage giomer. | Experimental | Low-shrinkage bioactive material (giomer) will be applied according to the manufacturer's instructions. Centripetal technique will be performed to restore the proximal wall followed by oblique incrementation of approximately 2 mm thick composite resin. This will be followed by light curing of each increment for 40 seconds using light curing unit till the whole cavity is filled. Receives: Drug: Beautifil II LS (Low-Shrinkage) |
| Nano-hybrid resin composite | Active comparator | Nano-hybrid resin composite will be applied according to the manufacturer's instructions. Centripetal technique will be performed to restore the proximal wall followed by oblique incrementation of approximately 2 mm thick composite resin. Composite increments will be adapted obliquely on each cusp. This will be followed by light curing for 40 seconds using light curing unit of each increment till the whole cavity is filled. Receives: Drug: 3M Filtek Z250 XT Universal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional properties (F1) Fracture of material and retention according to revised FDI (World Dental Federation) criteria. Measured by visual examination and short air drying.
Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Measured: 24 months
Secondary outcomes (4)
Quantitative occlusal restoration wear by Digital Intra-oral scanner and Geometrical subtraction software.
Method of aggregation is Mean (SD) (parametric) or Median (Range) (Non-parametric). Measuring unit is Microns.
Measured: 24 months.
Functional properties according to revised FDI (World Dental Federation) criteria.
Functional properties:
F2: Marginal adaptation measured by visual examination, short air drying, 250 μm probe.
F3:Proximal contact point measured by visual examination and 25/50/100 μm blades.
F4: Form and contour measured by visual examination. F5: Occlusion and occlusal wear measured by visual examination and articulation paper.
Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Measured: 24 months.
Biological properties according to revised FDI criteria.
Biological properties:
B1: Caries at restoration margin (CAR) measured by visual examination, short air drying, and 250 μm probe.
B2: Dental hard tissue defects at restoration margin measured by visual examination.
B3: Postoperative hypersensitivity reported by patient and pulp status tested with cold stimulus.
Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Measured: 24 months.
Aesthetic properties according to revised FDI criteria.
Aesthetic properties:
A1: Surface luster and surface texture measured by visual examination and short air drying.
A2: Marginal staining measured by visual examination and short air drying. A3: color match measured by visual examination. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Measured: 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries Class IIStudies 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Osama Shaalan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949502
- Sponsor's protocol ID
- Low shrinkage giomer
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance and Occlusal Wear of Low Shrinkage Giomer Compared to Nanohybrid Resin Composite in Proximal Restorations After Two Years: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05949502
- Acronym / sponsor ID
- Low shrinkage giomer
- Conditions
- Caries Class II
- Keywords
- Low-shrinkage Giomer, Nano-hybrid composite, Revised FDI criteria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 18 Jul 2023 (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.
A clinical trial, comparing the clinical performance and occlusal wear resistance of two different restorative materials in restoring proximal caries in permanent posterior teeth. One is based on giomer technology and the other is nano-hybrid resin composite.
Detailed description
The aim of this study is to assess clinical performance and occlusal wear resistance of low shrinkage Giomer and Nanohybrid Resin Composite in proximal restorations using revised FDI (World Dental Federation) criteria and digital intra-oral scanner.
Two different restorative materials will be evaluated after two years for fracture, retention and occlusal wear. Furthermore, the rest of the revised FDI Criteria including functional (marginal adaptation, proximal contact point, form and contour, occlusion and occlusal wear) , biological (caries at restoration margin (CAR), dental hard tissue defects at restoration margin and postoperative hypersensitivity/pulp status) and esthetic properties (surface luster and surface texture, marginal staining and color match) will be also evaluated.
The first material is based on the giomer technology which is a true hybrid between nano-hybrid resin composite and glass ionomer. The comparator will be a nano-hybrid resin composite.
Examination and selection of all patients will be done. Teeth with proximal, primary carious lesions will be selected. Rubber dam isolation will be done followed by preparation of Class II cavities and placement of restorative material according to the randomization sequence.
Low-shrinkage bioactive material will be applied according to the manufacturer's instructions. For the comparator group, nano-hybrid resin composite will be also applied according to the manufacturer's instructions. Restorations will evaluated at baseline, after six, 12, 18 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low shrinkage giomer. | Experimental | Drug: Beautifil II LS (Low-Shrinkage)Low-shrinkage bioactive material (giomer) will be applied according to the manufacturer's instructions. Centripetal technique will be performed to restore the proximal wall followed by oblique incrementation of approximately 2 mm thick composite resin. This will be followed by light curing of each increment for 40 seconds using light curing unit till the whole cavity is filled. |
| Nano-hybrid resin composite | Active comparator | Drug: 3M Filtek Z250 XT UniversalNano-hybrid resin composite will be applied according to the manufacturer's instructions. Centripetal technique will be performed to restore the proximal wall followed by oblique incrementation of approximately 2 mm thick composite resin. Composite increments will be adapted obliquely on each cusp. This will be followed by light curing for 40 seconds using light curing unit of each increment till the whole cavity is filled. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
Key exclusion criteria (20 listed)
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 |
|---|---|---|
| Beautifil II LS (Low-Shrinkage)Also: low shrinkage Giomerlow shrinkage bioactive material Giomer | Drug | Low shrinkage giomer. |
| 3M Filtek Z250 XT UniversalAlso: Nano-hybrid compositeUniversal Nano-hybrid composite | Drug | Nano-hybrid resin composite |
Primary outcome
Functional properties (F1) Fracture of material and retention according to revised FDI (World Dental Federation) criteria. Measured by visual examination and short air drying.
Time frame: 24 months
Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
4 secondary outcomes
Quantitative occlusal restoration wear by Digital Intra-oral scanner and Geometrical subtraction software.
Time frame: 24 months.
Functional properties according to revised FDI (World Dental Federation) criteria.
Time frame: 24 months.
Biological properties according to revised FDI criteria.
Time frame: 24 months.
Aesthetic properties according to revised FDI criteria.
Time frame: 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Beautifil II LS (Low-Shrinkage) and 3M Filtek Z250 XT Universal in people with Caries Class II, run by Cairo University.
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 9 inclusion and 20 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 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Marwa AbdelHafez, MS.C (00201002894668, Marwa.abdelHafez@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional properties (F1) Fracture of material and retention according to revised FDI (World Dental Federation) criteria. Measured by visual examination and short air drying. (time frame: 24 months). 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 18 Jul 2023.