Proximal CariesNCT04677023
Evaluation of Organically Modified Ceramic Resin Composite Versus Bulkfill Resin in Proximal Posterior Cavities
A study testing GrandioSO x-tra® bulk and Admira fusion X--tra® bulk in people with Proximal Caries, run by Cairo University.
Trial summary
In patients with compound posterior proximal cavities, will the use of organically modified ceramic resin composite restorative material have similar clinical performance to conventional bulk fill resin composite, evaluation of restorations will be done at baseline,six and twelve months using World Dental Federation… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Proximal Caries
- What is being tested?
- GrandioSO x-tra® bulk and Admira fusion X--tra® bulk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Feb 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aging ≥18 years.
- Patients with a high level of oral hygiene.
- Patients having at least 1or 2 posterior teeth in occlusion.
- Patients with good likelihood of recall availability.
- Tooth inclusion:
- Permanent premolars or molars.
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- Moderate to deep compound class II cavities.
- Primary carious lesions.
- Vital with positive reaction to cold thermal stimulus.
- Well-formed and fully-erupted in normal functional occlusion with natural antagonist and adjacent teeth.
Who cannot join
- Participants with general/systemic illness.
- Pregnant or lactating females.
- Concomitant participation in another research study.
- Inability to comply with study procedures.
- Heavy bruxism habits.
- Last experience with allergic reactions against any components of the used materials.
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- Patients receiving orthodontic treatment.
- Tooth exclusion:
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth.
- Secondary carious lesions.
About this study
Official title: Clinical Evaluation of Organically Modified Ceramic Resin Composite Versus Conventional Bulkfill Resin Composite in Proximal Compound Posterior Restorations: Randomized Clinical
In patients with compound posterior proximal cavities, will the use of organically modified ceramic resin composite restorative material have similar clinical performance to conventional bulk fill resin composite, evaluation of restorations will be done at baseline,six and twelve months using World Dental Federation FDI criteria.
Read the detailed description
The study will be conducted in the clinic of Conservative Dentistry Department, Faculty of Dentistry, Cairo University; the operator in charge Safinaz Hussien ,The subjects fulfilling the eligibility criteria of the trial will be selected from the regular attendees at the clinic of Conservative Dentistry Department, Faculty of Dentistry, Cairo University.Patient examination will be done including medical history, dental history, extra-oral examination and intra-oral examination. A periapical radiograph will be taken prior to restorative procedures to assess the degree of approximation of caries to pulp, intactness of lamina dura and/or presence of any periapical radiolucency to exclude the case.The field of operation will be isolated with the application of a rubber dam if possible. Otherwise, cotton rolls and the saliva ejector will be used for moisture control. For cavity preparation, local anesthetic (Mepecaine-L, Alexandria Company, Egypt) solution will be administrated to control patient discomfort during the procedure.The cavities will be prepared by using cylindrical #314 (Komet®, Germany) in a high speed handpiece (Sirona, Germany) rotating at high speed with copious coolant. Remaining soft caries -if present- will be removed using sharp excavator (Maillefer, Dentsuply, Switzerland).After the cavity preparation is finished, it will be thoroughly air-water cleaned. The bonding system; FuturabondU(Voco, Germany) will be applied according to the following instructions recommended by the manufacturer: Futurabond M+ will be applied to prepared tooth structure and cured for 20 seconds using Elipar™ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2. The prepared cavities will be restored with Admira fusion X--tra® bulk (VOCO, Cuxhaven in layers that are a maximum of 4 mm thick then cured for 20 seconds using usingElipar™ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2. and for the control group cavities will be restored with GrandioSO x-tra(VOCO, Cuxhaven) in layers that are a maximum of 4 mm thick then cured for 20 seconds using usingElipar™ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2.
- Conditions
- Proximal Caries
- Being tested
- GrandioSO x-tra® bulk, Admira fusion X--tra® bulk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrandioSO x-tra® bulkOther
The prepared cavities will be restored with GrandioSO X-tra (VOCO, Cuxhaven, Germany) in layers that are a maximum of 4 mm thick then cured for 20 seconds using using Elipar™️ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2.
Admira fusion X--tra® bulkOther
he prepared cavities will be restored with Admira fusion X-tra®️ bulk (VOCO, Cuxhaven, Germany) in layers that are a maximum of 4 mm thick then cured for 20 seconds using usingElipar™️ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2.
| Study group | Role | What they receive |
|---|---|---|
| Admira fusion X--tra® bulk | Other | The special ORMOCER® compound molecules in Admira Fusion x-tra reduce the volume shrinkage to an extremely low level (1.25 % by volume) in conjunction with very low shrinkage stress (3.87 MPa). Admira Fusion x-tra is the bulk fill version of Admira Fusion. This means that this restorative material can be applied in layers of up to 4 mm and then reliably cured. This makes placing posterior restorations particularly quick and economical. The universal shade U further simplifies handling, as it provides aesthetic results by adapting, chameleon-like, to the surrounding dental substance Receives: Other: Admira fusion X--tra® bulk |
| GrandioSO x-tra® bulk | Other | a nano-hybrid composite which is in a class of its own. It is distinguished by outstanding handling and excellent physical properties, modelled on the natural tooth.its the packable bulk fill material for the highest standards in durability and aesthetics.GrandioSO x-tra has outstanding surface hardness, at 223 MHV, which is closer to natural tooth enamel, compared with other bulk fill composites. Because of this, GrandioSO x-tra ensures restorations which are abrasionresistant and dimensionally stable over the long term. In addition to the surface hardness, reliable curing is very important when larger increments are used. Here as well, GrandioSO x-tra achieves an outstanding result and, at the 219 MHV measured at a depth of 4 mm, it even significantly exceeds the values measured for other bulk fill composites at the surface. Receives: Other: GrandioSO x-tra® bulk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture
Fracture of material visually inspected and evaluated using FDI probe and then classified accordingly
- clinically excellent/very good: No fractures /cracks.
- Clinically good: Small hairline crack.
- Clinically sufficient /satisfactory(minor shortcomings, no unacceptable effects but not adjustable w/or damage to the tooth):Two or more or larger hairline cracks and/or material chipfracture no affecting the marginal integrity or approximal contact.
- Clinically unsatisfactory /(but reparable):Material chip fractures which damage marginal quality or Bulk fractures with partial loss(less than half of the restoration). ditching or marginal fractures.
- Clinically poor (replacement necessary): (Partial or complete) loss of restoration or multiple fractures.
Measured: 24 months
Secondary outcomes (1)
color match
Esthetic visually inspected and evaluated using FDI probe and then classified
- clinically excellent/very good Luster comparable to enamel,\& , no difference in shade
- Clinically good Slightly dull, \& minor shade deviation
- Clinically sufficient /satisfactory. Dull surface \& distinct shade deviation
- Clinically unsatisfactory /(but reparable) Rough surface, \& localized shade deviation that can be repaired
- Clinically poor (replacement necessary): Very rough \& un acceptable shade need replacement
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 posted21 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal CariesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, safinaz hussien fahmy hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677023
- Sponsor's protocol ID
- 88960
- Status last verified
- Dec 2020
- First submitted
- 15 Sep 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Organically Modified Ceramic Resin Composite Versus Conventional Bulkfill Resin Composite in Proximal Compound Posterior Restorations: Randomized Clinical
- ClinicalTrials.gov ID
- NCT04677023
- Acronym / sponsor ID
- 88960
- Conditions
- Proximal Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 21 Dec 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.
In patients with compound posterior proximal cavities, will the use of organically modified ceramic resin composite restorative material have similar clinical performance to conventional bulk fill resin composite, evaluation of restorations will be done at baseline,six and twelve months using World Dental Federation FDI criteria.
Detailed description
The study will be conducted in the clinic of Conservative Dentistry Department, Faculty of Dentistry, Cairo University; the operator in charge Safinaz Hussien ,The subjects fulfilling the eligibility criteria of the trial will be selected from the regular attendees at the clinic of Conservative Dentistry Department, Faculty of Dentistry, Cairo University.Patient examination will be done including medical history, dental history, extra-oral examination and intra-oral examination. A periapical radiograph will be taken prior to restorative procedures to assess the degree of approximation of caries to pulp, intactness of lamina dura and/or presence of any periapical radiolucency to exclude the case.The field of operation will be isolated with the application of a rubber dam if possible. Otherwise, cotton rolls and the saliva ejector will be used for moisture control. For cavity preparation, local anesthetic (Mepecaine-L, Alexandria Company, Egypt) solution will be administrated to control patient discomfort during the procedure.The cavities will be prepared by using cylindrical #314 (Komet®, Germany) in a high speed handpiece (Sirona, Germany) rotating at high speed with copious coolant. Remaining soft caries -if present- will be removed using sharp excavator (Maillefer, Dentsuply, Switzerland).After the cavity preparation is finished, it will be thoroughly air-water cleaned. The bonding system; FuturabondU(Voco, Germany) will be applied according to the following instructions recommended by the manufacturer: Futurabond M+ will be applied to prepared tooth structure and cured for 20 seconds using Elipar™ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2. The prepared cavities will be restored with Admira fusion X--tra® bulk (VOCO, Cuxhaven in layers that are a maximum of 4 mm thick then cured for 20 seconds using usingElipar™ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2. and for the control group cavities will be restored with GrandioSO x-tra(VOCO, Cuxhaven) in layers that are a maximum of 4 mm thick then cured for 20 seconds using usingElipar™ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Admira fusion X--tra® bulk | Other | Other: Admira fusion X--tra® bulkThe special ORMOCER® compound molecules in Admira Fusion x-tra reduce the volume shrinkage to an extremely low level (1.25 % by volume) in conjunction with very low shrinkage stress (3.87 MPa). Admira Fusion x-tra is the bulk fill version of Admira Fusion. This means that this restorative material can be applied in layers of up to 4 mm and then reliably cured. This makes placing posterior restorations particularly quick and economical. The universal shade U further simplifies handling, as it provides aesthetic results by adapting, chameleon-like, to the surrounding dental substance |
| GrandioSO x-tra® bulk | Other | Other: GrandioSO x-tra® bulka nano-hybrid composite which is in a class of its own. It is distinguished by outstanding handling and excellent physical properties, modelled on the natural tooth.its the packable bulk fill material for the highest standards in durability and aesthetics.GrandioSO x-tra has outstanding surface hardness, at 223 MHV, which is closer to natural tooth enamel, compared with other bulk fill composites. Because of this, GrandioSO x-tra ensures restorations which are abrasionresistant and dimensionally stable over the long term. In addition to the surface hardness, reliable curing is very important when larger increments are used. Here as well, GrandioSO x-tra achieves an outstanding result and, at the 219 MHV measured at a depth of 4 mm, it even significantly exceeds the values measured for other bulk fill composites at the surface. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients aging ≥18 years.
- Patients with a high level of oral hygiene.
- Patients having at least 1or 2 posterior teeth in occlusion.
- Patients with good likelihood of recall availability.
- Permanent premolars or molars.
Key exclusion criteria (11 listed)
- Participants with general/systemic illness.
- Pregnant or lactating females.
- Concomitant participation in another research study.
- Inability to comply with study procedures.
- Heavy bruxism habits.
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 |
|---|---|---|
| GrandioSO x-tra® bulkThe prepared cavities will be restored with GrandioSO X-tra (VOCO, Cuxhaven, Germany) in layers that are a maximum of 4 mm thick then cured for 20 seconds using using Elipar™️ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2. | Other | GrandioSO x-tra® bulk |
| Admira fusion X--tra® bulkhe prepared cavities will be restored with Admira fusion X-tra®️ bulk (VOCO, Cuxhaven, Germany) in layers that are a maximum of 4 mm thick then cured for 20 seconds using usingElipar™️ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2. | Other | Admira fusion X--tra® bulk |
Primary outcome
Fracture
Time frame: 24 months
Fracture of material visually inspected and evaluated using FDI probe and then classified accordingly 1. clinically excellent/very good: No fractures /cracks. 2. Clinically good: Small hairline crack. 3. Clinically sufficient /satisfactory(minor shortcomings, no unacceptable effects but not adjustable w/or damage to the tooth):Two or more or larger hairline cracks and/or material chipfracture no affecting the marginal integrity or approximal contact. 4. Clinically unsatisfactory /(but reparable):Material chip fractures which damage marginal quality or Bulk fractures with partial loss(less than half of the restoration). ditching or marginal fractures. 5. Clinically poor (replacement necessary): (Partial or complete) loss of restoration or multiple fractures.
1 secondary outcome
color match
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 23 Dec 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing GrandioSO x-tra® bulk and Admira fusion X--tra® bulk in people with Proximal Caries, 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 10 inclusion and 11 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 23 Dec 2020. 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?
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?
Fracture (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 23 Dec 2020.