Caries Class IINCT04790383
Clinical Performance of Advanced Self- Adhesivee Resin Composite Hybrid Restorations.
A study testing Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)). and Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona in people with Caries Class II and Caries,Dental, run by Rawda Hesham Abd ElAziz at 1 site in Egypt.
Trial summary
Clinical performance according to modified USPHS criteria of advanced self-Adhesive resin composite hybrid restorations is evaluated for 1 year versus conventional resin composite restorations in posterior teeth. Read more about this study
- Who is it for?
- Ages 17 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Class II, Caries,Dental
- What is being tested?
- Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)). and Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to Mar 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 17 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with carious proximal cavities in molars
- Good oral hygiene.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Who cannot join
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
- Severe periodontal problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Advanced Self-Adhesive Resin Composite Hybrid Restorations Versus Conventional Resin Composite Restorations in Posterior Teeth (1y Randomized Clinical Trial).
Clinical performance according to modified USPHS criteria of advanced self-Adhesive resin composite hybrid restorations is evaluated for 1 year versus conventional resin composite restorations in posterior teeth.
- Conditions
- Caries Class II, Caries,Dental
- Being tested
- Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona))., Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona
- Keywords
- self-Adhesive resin composite hybrid restorations, Posterior resin composite, Surefil One
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)).Other
Hybrid resin composite that doesn't need bonding system and releases calcium and flouride.
Conventional resin composite restoration. (Sphere Tec, (Dentsply SironaOther
Conventional Nanohybrid resin composite
| Study group | Role | What they receive |
|---|---|---|
| Advanced Self-Adhesive resin composite hybrid restorations | Experimental | (Surefil one (Dentsply Sirona)). Receives: Other: Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)). |
| Conventional resin composite restoration. | Active comparator | Sphere Tec, (Dentsply Sirona) Receives: Other: Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
Post operative Hypersensitivity, Secondary caries, Gross fracture, Cavo-surface marginal discoloration, Proximal contact.
All these outcomes are measured by a score Alpha is excellent, Bravo is acceptable, Charlie is not accepted
Measured: Change from baseline at 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Feb 2021
- Primary completionFeb 2022 (estimated)
- Study completionMar 2022 (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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawda Hesham Abd ElAziz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rawda Hesham Abd ElAziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790383
- Sponsor's protocol ID
- CU-2-2021
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Advanced Self-Adhesive Resin Composite Hybrid Restorations Versus Conventional Resin Composite Restorations in Posterior Teeth (1y Randomized Clinical Trial).
- ClinicalTrials.gov ID
- NCT04790383
- Acronym / sponsor ID
- CU-2-2021
- Conditions
- Caries Class II, Caries,Dental
- Keywords
- self-Adhesive resin composite hybrid restorations, Posterior resin composite, Surefil One
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Rawda Hesham Abd ElAzizUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 10 Mar 2021 (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.
Clinical performance according to modified USPHS criteria of advanced self-Adhesive resin composite hybrid restorations is evaluated for 1 year versus conventional resin composite restorations in posterior teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Self-Adhesive resin composite hybrid restorations | Experimental | Other: Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)).(Surefil one (Dentsply Sirona)). |
| Conventional resin composite restoration. | Active comparator | Other: Conventional resin composite restoration. (Sphere Tec, (Dentsply SironaSphere Tec, (Dentsply Sirona) |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with carious proximal cavities in molars
- Good oral hygiene.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Key exclusion criteria (2 listed)
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
- Severe periodontal 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 |
|---|---|---|
| Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)).Hybrid resin composite that doesn't need bonding system and releases calcium and flouride. | Other | Advanced Self-Adhesive resin composite hybrid restorations |
| Conventional resin composite restoration. (Sphere Tec, (Dentsply SironaConventional Nanohybrid resin composite | Other | Conventional resin composite restoration. |
Primary outcome
Clinical performance
Time frame: Change from baseline at 6, 12 months
Post operative Hypersensitivity, Secondary caries, Gross fracture, Cavo-surface marginal discoloration, Proximal contact. All these outcomes are measured by a score Alpha is excellent, Bravo is acceptable, Charlie is not accepted
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Caries Class II
Active, not recruiting
Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities
Caries, Defective Restorations
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Active, not recruiting
Clinical Performance of Different Ion-Releasing Restorative Systems in Class II Cavities
Dental Caries
Active, not recruiting
Bioactive Restorative Materials for Class II Restorations
Bioactive Dental Restorative Materials, Class II Dental Caries
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)). and Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona in people with Caries Class II and Caries,Dental, run by Rawda Hesham Abd ElAziz at 1 site in Egypt.
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 2 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 10 Mar 2021. 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 Egypt. 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 Rawda Hesham Hesham A.ElAziz (+201001097200, rawda.hesham@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance (time frame: Change from baseline at 6, 12 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 10 Mar 2021.