Dental Restoration FailureNCT03608306
Clinical Performance of Bioactive Restorative Material Versus Glass Hybrid Restorative in Posterior Restorations
A study testing Resin-modified glass ionomer and Bulk-fill glass hybrid restorative in people with Dental Restoration Failure, run by Cairo University.
Trial summary
Clinical performance of bioactive restorative material versus glass hybrid restorative in posterior restorations of high caries risk patients will be evaluated over 12 months using Fédération Dentaire Internationale' (FDI) clinical criteria for the evaluation of direct and indirect restorations 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
- What is being tested?
- Resin-modified glass ionomer and Bulk-fill glass hybrid restorative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Jun 2020
- 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
- High caries risk patients with multiple posterior cavitated carious lesions
- Co-operative patients approving to participate in the study.
- Pulp asymptomatic vital carious posterior teeth.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Who cannot join
- Low caries risk patients.
- Anterior carious lesions
- Lack of compliance
- Severe medical complications.
- Pregnancy.
- Evidence of parafunctional habits
- Temporomandibular joint disorders
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Performance of Bioactive Restorative Material Versus Glass Hybrid Restorative in Posterior Restorations of High Caries Risk Patients: Randomized Clinical Trial
Clinical performance of bioactive restorative material versus glass hybrid restorative in posterior restorations of high caries risk patients will be evaluated over 12 months using Fédération Dentaire Internationale' (FDI) clinical criteria for the evaluation of direct and indirect restorations
Read the detailed description
The application of resin composite has been described as "technique sensitive". Although glass ionomers are inferior to resin composite in esthetics, there are specific clinical situations where glass ionomers are the materials of choice for restoring teeth as patients at risk for caries and with carious lesions due to its ability to release fluoride and to self-adhere to enamel and dentin.
However, Conventional glass ionomer have poor physical and mechanical properties and are more liable to wear when compared to resin composite. The change in formulation of resin modified glass ionomer restorations allowed them to have improved physic-mechanical properties, combined with significant improvement in esthetic properties. Thus, in recent years glass ionomer as direct restorative materials have become more user friendly. Unfortunately, most of glass ionomers are not recommended as definitive final restorations for the permanent dentition in stress bearing areas because they do not have the physical and mechanical properties of amalgam or composite resin.
ACTIVA™ BioACTIVE-RESTORATIVE™ is recently introduced enhanced resin modified glass ionomer, which the manufacturer (Pulpdent Corporation, USA) reports to be the first bioactive dental materials with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic physical and chemical properties of natural teeth. They are durable, fracture and wear resistant, chemically bond to teeth, seal against bacterial microleakage, and release and recharge with calcium, phosphate, and more fluoride ions than glass ionomers. Thus, ACTIVA has more release and recharge of calcium, phosphate and fluoride than glass ionomers with the esthetics, strength, and physical properties of composites, combining the best attributes of both materials without compromising either one.
EQUIA® Forte is a fluoride-releasing, bulk-fill system which consists of EQUIA® Forte Fil, a high strength glass hybrid restorative, and EQUIA® Forte Coat, a wear-resistant, self-adhesive, light-cured resin coating. With improved flexural strength, and acid and wear resistance, the manufacturer claims that EQUIA® Forte extends the recommended indications to include stress-bearing Class II restorations.
The clinical performance of these materials regarding functional, esthetic and biological properties is yet to be evaluated. The FDI clinical criteria provide more detailed evaluation criteria and better differentiation between different types of failure; and incorporate objective assessment tools and a clear scoring system than other scoring systems. Thus, this study aims to contribute to providing evidence-based literature concerning current innovative Resin-modified glass ionomer restorations using the most updated and standardized assessment criteria, namely the FDI.
- Conditions
- Dental Restoration Failure
- Being tested
- Resin-modified glass ionomer, Bulk-fill glass hybrid restorative
- Keywords
- Clinical Performance, Bioactive Restorative Material, Glass Hybrid Restorative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin-modified glass ionomerOther
Also called Activa Bioactive-Restorative
enhanced RMGIs with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth.
Bulk-fill glass hybrid restorativeOther
Also called EQUIA Forte
It's a bulk-fill, fluoride-releasing restorative system that combines EQUIA Forte Fil, which is a high strength glass hybrid restorative, and EQUIA Forte Coat, a wear-resistant, self-adhesive, light-cured resin coating.
| Study group | Role | What they receive |
|---|---|---|
| Resin-modified glass ionomer | Experimental | Activa Bioactive-Restorative is an enhanced resin modified glass ionomer (RMGI) with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth. Receives: Other: Resin-modified glass ionomer |
| Bulk-fill glass hybrid restorative | Active comparator | EQUIA Forte is a bulk-fill, fluoride-releasing restorative system that combines EQUIA Forte Fil, which is a high strength glass hybrid restorative, and EQUIA Forte Coat, a wear-resistant, self-adhesive, light-cured resin coating. Receives: Other: Bulk-fill glass hybrid restorative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations
(FDI) criteria includes :
- Biological properties (Postoperative hypersensitivity \& tooth vitality, Recurrence of caries, erosion \& abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth),Adjacent mucosa, Oral \& general health)
- Esthetic properties (Surface luster, Staining (surface \&margin),Color match \& translucency \& Esthetic anatomical form)
- Functional properties (Fracture or material retention, Marginal integrity, Occlusal contour \&wear (quantitatively \& qualitatively), Proximal anatomical form(contact point \&contour), Radiographic examination(when applicable) \&Patient's view)
For each criteria one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor).
Subscales will not be combined
Measured: Change from the baseline at 6 months and12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study startOct 2018 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental Restoration FailureStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona mahmoud Abd Elrahman, Cairo University
- Investigators
- Mai M Yousry, PhD, Study director, Professor of Conservative Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608306
- Sponsor's protocol ID
- CEBD-CU-2018-07-11
- Status last verified
- Jul 2018
- First submitted
- 24 Jul 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bansal R, Burgess J, Lawson NC. Wear of an enhanced resin-modified glass-ionomer restorative material. Am J Dent. 2016 Jun;29(3):171-4.
PubMed 27505995Fleming GJ, Awan M, Cooper PR, Sloan AJ. The potential of a resin-composite to be cured to a 4mm depth. Dent Mater. 2008 Apr;24(4):522-9. doi: 10.1016/j.dental.2007.05.016. Epub 2007 Jul 31.
PubMed 17669481Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
PubMed 20628774Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007 Mar;11(1):5-33. doi: 10.1007/s00784-006-0095-7. Epub 2007 Jan 30.
PubMed 17262225Pameijer CH, Garcia-Godoy F, Morrow BR, Jefferies SR. Flexural strength and flexural fatigue properties of resin-modified glass ionomers. J Clin Dent. 2015;26(1):23-7.
PubMed 26054188
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Bioactive Restorative Material Versus Glass Hybrid Restorative in Posterior Restorations of High Caries Risk Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03608306
- Acronym / sponsor ID
- CEBD-CU-2018-07-11
- Conditions
- Dental Restoration Failure
- Keywords
- Clinical Performance, Bioactive Restorative Material, Glass Hybrid Restorative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 31 Jul 2018 (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 bioactive restorative material versus glass hybrid restorative in posterior restorations of high caries risk patients will be evaluated over 12 months using Fédération Dentaire Internationale' (FDI) clinical criteria for the evaluation of direct and indirect restorations
Detailed description
The application of resin composite has been described as "technique sensitive". Although glass ionomers are inferior to resin composite in esthetics, there are specific clinical situations where glass ionomers are the materials of choice for restoring teeth as patients at risk for caries and with carious lesions due to its ability to release fluoride and to self-adhere to enamel and dentin.
However, Conventional glass ionomer have poor physical and mechanical properties and are more liable to wear when compared to resin composite. The change in formulation of resin modified glass ionomer restorations allowed them to have improved physic-mechanical properties, combined with significant improvement in esthetic properties. Thus, in recent years glass ionomer as direct restorative materials have become more user friendly. Unfortunately, most of glass ionomers are not recommended as definitive final restorations for the permanent dentition in stress bearing areas because they do not have the physical and mechanical properties of amalgam or composite resin.
ACTIVA™ BioACTIVE-RESTORATIVE™ is recently introduced enhanced resin modified glass ionomer, which the manufacturer (Pulpdent Corporation, USA) reports to be the first bioactive dental materials with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic physical and chemical properties of natural teeth. They are durable, fracture and wear resistant, chemically bond to teeth, seal against bacterial microleakage, and release and recharge with calcium, phosphate, and more fluoride ions than glass ionomers. Thus, ACTIVA has more release and recharge of calcium, phosphate and fluoride than glass ionomers with the esthetics, strength, and physical properties of composites, combining the best attributes of both materials without compromising either one.
EQUIA® Forte is a fluoride-releasing, bulk-fill system which consists of EQUIA® Forte Fil, a high strength glass hybrid restorative, and EQUIA® Forte Coat, a wear-resistant, self-adhesive, light-cured resin coating. With improved flexural strength, and acid and wear resistance, the manufacturer claims that EQUIA® Forte extends the recommended indications to include stress-bearing Class II restorations.
The clinical performance of these materials regarding functional, esthetic and biological properties is yet to be evaluated. The FDI clinical criteria provide more detailed evaluation criteria and better differentiation between different types of failure; and incorporate objective assessment tools and a clear scoring system than other scoring systems. Thus, this study aims to contribute to providing evidence-based literature concerning current innovative Resin-modified glass ionomer restorations using the most updated and standardized assessment criteria, namely the FDI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin-modified glass ionomer | Experimental | Other: Resin-modified glass ionomerActiva Bioactive-Restorative is an enhanced resin modified glass ionomer (RMGI) with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth. |
| Bulk-fill glass hybrid restorative | Active comparator | Other: Bulk-fill glass hybrid restorativeEQUIA Forte is a bulk-fill, fluoride-releasing restorative system that combines EQUIA Forte Fil, which is a high strength glass hybrid restorative, and EQUIA Forte Coat, a wear-resistant, self-adhesive, light-cured resin coating. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- High caries risk patients with multiple posterior cavitated carious lesions
- Co-operative patients approving to participate in the study.
- Pulp asymptomatic vital carious posterior teeth.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Key exclusion criteria (8 listed)
- Low caries risk patients.
- Anterior carious lesions
- Lack of compliance
- Severe medical complications.
- Pregnancy.
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 |
|---|---|---|
| Resin-modified glass ionomerAlso: Activa Bioactive-Restorativeenhanced RMGIs with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth. | Other | Resin-modified glass ionomer |
| Bulk-fill glass hybrid restorativeAlso: EQUIA ForteIt's a bulk-fill, fluoride-releasing restorative system that combines EQUIA Forte Fil, which is a high strength glass hybrid restorative, and EQUIA Forte Coat, a wear-resistant, self-adhesive, light-cured resin coating. | Other | Bulk-fill glass hybrid restorative |
Primary outcome
Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations
Time frame: Change from the baseline at 6 months and12 months
(FDI) criteria includes : * Biological properties (Postoperative hypersensitivity \& tooth vitality, Recurrence of caries, erosion \& abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth),Adjacent mucosa, Oral \& general health) * Esthetic properties (Surface luster, Staining (surface \&margin),Color match \& translucency \& Esthetic anatomical form) * Functional properties (Fracture or material retention, Marginal integrity, Occlusal contour \&wear (quantitatively \& qualitatively), Proximal anatomical form(contact point \&contour), Radiographic examination(when applicable) \&Patient's view) For each criteria one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor). Subscales will not be combined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Background: PubMed 27505995Bansal R, Burgess J, Lawson NC. Wear of an enhanced resin-modified glass-ionomer restorative material. Am J Dent. 2016 Jun;29(3):171-4.
- Background: PubMed 17669481Fleming GJ, Awan M, Cooper PR, Sloan AJ. The potential of a resin-composite to be cured to a 4mm depth. Dent Mater. 2008 Apr;24(4):522-9. doi: 10.1016/j.dental.2007.05.016. Epub 2007 Jul 31.
- Background: PubMed 20628774Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
- Background: PubMed 17262225Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007 Mar;11(1):5-33. doi: 10.1007/s00784-006-0095-7. Epub 2007 Jan 30.
- Background: PubMed 26054188Pameijer CH, Garcia-Godoy F, Morrow BR, Jefferies SR. Flexural strength and flexural fatigue properties of resin-modified glass ionomers. J Clin Dent. 2015;26(1):23-7.
- 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.
Mai M Yousry, PhD study director
Professor of Conservative Dentistry, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Resin-modified glass ionomer and Bulk-fill glass hybrid restorative in people with Dental Restoration Failure, 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 4 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 2 Aug 2018. 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 Mona M Abd Elrahman, Master (1142077937 ext. +02, monamahmoud@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations (time frame: Change from the baseline at 6 months and12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03608306, which also lists 5 linked publications.
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 2 Aug 2018.