Dental Restoration Failure of Marginal IntegrityNCT03283280
Clinical Performance of Short Fiber Reinforced Resin Composite Versus Indirect Nanohybrid Resin Composite Onlay Restorations.
A study testing Ever X Posterior in people with Dental Restoration Failure of Marginal Integrity, run by Cairo University at 1 site in Egypt.
Trial summary
clinical performance of short fiber reinforced resin composite versus indirect nanohybrid resin composite onlay restorations in complex proximal cavities of molar teeth will be evaluated over one year. Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure of Marginal Integrity
- What is being tested?
- Ever X Posterior
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 1 Jul 2019
- 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 16 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pulp asymptomatic vital carious upper or lower molars.
- Proximal complex carious cavities involving one or two weak cusps.
- Replacement of old amalgam or resin composite restoration due to recurrent caries or either tooth or restoration fracture.
- Presence of favorable occlusion.
- Healthy volunteers
Who cannot join
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
- Deep subgingival cavity margins.
- Possible future prosthodontic restoration of teeth.
- Severe periodontal problems.
- Medically compromised patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Short Fiber Reinforced Resin Composite Restorations Versus Indirect Nanohybrid Resin Composite Onlay Restorations in Complex Proximal Cavities of Molars
clinical performance of short fiber reinforced resin composite versus indirect nanohybrid resin composite onlay restorations in complex proximal cavities of molar teeth will be evaluated over one year.
Read the detailed description
Resin composite materials have been rapidly developed in the latest few years. Direct resin composite restorations become the golden standard for restoring intracoronal cavities. While for the extracoronal cavities, the indirect resin composite onlays tend to replace metallic restorations in most situations being more esthetic and conservative with lower cost (Rocca \& Krejci, 2007).
Indirect resin composite onlays usually are lab processed in two appointments but it can be made in one appointment through CAD/CAM technology or by flexible model technique (semidirect technique).
These restorations offer more control on the proximal contacts and the anatomic form over the direct approach. Polymerization shrinkage occurs outside the patient mouth so the stresses are decreased and become limited to the width of the luting space. Annual failure rate (AFR) of indirect posterior resin composite restorations is up to 10% (Manhart et al, 2004).
One of the advancement in resin composite technology is the evolution of short fiber reinforced resin composite (SFRC) material that allows making a direct onlay restoration possible thus offers less procedural steps and saves more time (Garoushi et al, 2013).
This material is made to be used as a dentine substitute in the high stress-bearing areas. It is covered by a conventional resin composite filling to act as the enamel replacement this combination gives us a kind of biomimetic restoration.
- Being tested
- Ever X Posterior
- Keywords
- Short fiber reinforced resin composite, Nanohybrid resin composite, Indirect resin composite restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ever X PosteriorOther
Also called Short fiber reinforced resin composite
Resin composite restoration can be made as a direct onlay
| Study group | Role | What they receive |
|---|---|---|
| Short fiber RC | Experimental | Short fiber reinforced resin composite restoration (Ever X Posterior, Gc Europe) that is used in high stress bearing areas as direct onlay restoration. Receives: Other: Ever X Posterior |
| Nanohybrid RC | Active comparator | Nanohybrid resin composite (GrandioSO, VOCO GmbH Germany ) that can be used to make indirect restorations in posterior teeth. Receives: Other: Ever X Posterior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Clinical performance
Measured using modified USPHS criteria for clinical evaluation of restoration failure
Measured: Change from the Baseline at six months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start1 Feb 2018
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restoration Failure of Marginal IntegrityStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawda Hesham Abd ElAziz, Cairo University
- Investigators
- Rawda Hesham Abd ElAziz, Msc, Principal investigator, Assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283280
- Sponsor's protocol ID
- CEBD-CU-10-9-2017
- Status last verified
- Jul 2019
- First submitted
- 11 Sep 2017
- Last updated
- 25 Jul 2019
- 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 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Short Fiber Reinforced Resin Composite Restorations Versus Indirect Nanohybrid Resin Composite Onlay Restorations in Complex Proximal Cavities of Molars
- ClinicalTrials.gov ID
- NCT03283280
- Acronym / sponsor ID
- CEBD-CU-10-9-2017
- Keywords
- Short fiber reinforced resin composite, Nanohybrid resin composite, Indirect resin composite restoration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 14 Sep 2017 (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 of short fiber reinforced resin composite versus indirect nanohybrid resin composite onlay restorations in complex proximal cavities of molar teeth will be evaluated over one year.
Detailed description
Resin composite materials have been rapidly developed in the latest few years. Direct resin composite restorations become the golden standard for restoring intracoronal cavities. While for the extracoronal cavities, the indirect resin composite onlays tend to replace metallic restorations in most situations being more esthetic and conservative with lower cost (Rocca \& Krejci, 2007).
Indirect resin composite onlays usually are lab processed in two appointments but it can be made in one appointment through CAD/CAM technology or by flexible model technique (semidirect technique).
These restorations offer more control on the proximal contacts and the anatomic form over the direct approach. Polymerization shrinkage occurs outside the patient mouth so the stresses are decreased and become limited to the width of the luting space. Annual failure rate (AFR) of indirect posterior resin composite restorations is up to 10% (Manhart et al, 2004).
One of the advancement in resin composite technology is the evolution of short fiber reinforced resin composite (SFRC) material that allows making a direct onlay restoration possible thus offers less procedural steps and saves more time (Garoushi et al, 2013).
This material is made to be used as a dentine substitute in the high stress-bearing areas. It is covered by a conventional resin composite filling to act as the enamel replacement this combination gives us a kind of biomimetic restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short fiber RC | Experimental | Other: Ever X PosteriorShort fiber reinforced resin composite restoration (Ever X Posterior, Gc Europe) that is used in high stress bearing areas as direct onlay restoration. |
| Nanohybrid RC | Active comparator | Other: Ever X PosteriorNanohybrid resin composite (GrandioSO, VOCO GmbH Germany ) that can be used to make indirect restorations in posterior teeth. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Pulp asymptomatic vital carious upper or lower molars.
- Proximal complex carious cavities involving one or two weak cusps.
- Replacement of old amalgam or resin composite restoration due to recurrent caries or either tooth or restoration fracture.
- Presence of favorable occlusion.
- Healthy volunteers
Key exclusion criteria (5 listed)
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
- Deep subgingival cavity margins.
- Possible future prosthodontic restoration of teeth.
- Severe periodontal problems.
- Medically compromised patients.
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 |
|---|---|---|
| Ever X PosteriorAlso: Short fiber reinforced resin compositeResin composite restoration can be made as a direct onlay | Other | Nanohybrid RC, Short fiber RC |
Primary outcome
Change in the Clinical performance
Time frame: Change from the Baseline at six months and 12 months.
Measured using modified USPHS criteria for clinical evaluation of restoration failure
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 25 Jul 2019.
- Short fiber reinforced resin compositeLink provided by the sponsor.
- Indirect nanohybrid resin compositeLink provided by the sponsor.
- 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.
Rawda Hesham Abd ElAziz, Msc principal investigator
Assistant lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ever X Posterior in people with Dental Restoration Failure of Marginal Integrity, run by Cairo University 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 5 inclusion and 5 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 25 Jul 2019. 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?
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?
Change in the Clinical performance (time frame: Change from the Baseline at six months and 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 25 Jul 2019.