Class I Cavities in High Caries RiskNCT02856932
Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients
A study testing Conventional high viscosity glass ionomer and Glass ionomer with glass hybrid technology in people with Class I Cavities in High Caries Risk, run by Cairo University at 1 site in Egypt.
Trial summary
PICOTS: P: High Caries Risk Patients with bilateral class I cavities. I: Glass Ionomer with Glass Hybrid Technology. C: Conventional High Viscosity Glass Ionomer. O: Clinical performance (Functional properties Biological properties) using (World Dental Federation) Fédération dentaire internationale (FDI) criteria for… Read more about this study
- Who is it for?
- Ages 19 to 50 years
- Conditions the study is for
- Class I Cavities in High Caries Risk
- What is being tested?
- Conventional high viscosity glass ionomer and Glass ionomer with glass hybrid technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteEgypt
- Study dates
- Start not givento Sep 2018
- 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 50 years
- All sexes
- Adult
Who may be able to join
- Bilateral class I carious lesions in their occlusal pits and fissures.
- High caries risk patients who has 1 or more cavitated lesion with risk factor declared by Caries Management By Risk Assessment (CAMBRA)
- Co-operative patients approving to participate in the trial.
Who cannot join
- Disabilities.
- Systemic diseases or severe medically compromised.
- Lack of compliance.
- Evidence of severe bruxism, clenching or temporomandibular joint disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of oral and dental medicine, cairo university
Cairo, 11553
Amira F El-Zoghby, Professor, +201222106620, Amfzh52@yahoo.com
Ahmed A El-Zohairy, Associate professor, +201227848002, Aelzohairy@gmail.com
About this study
Official title: Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients: Randomized Controlled Trial
PICOTS:
P: High Caries Risk Patients with bilateral class I cavities. I: Glass Ionomer with Glass Hybrid Technology. C: Conventional High Viscosity Glass Ionomer. O: Clinical performance (Functional properties Biological properties) using (World Dental Federation) Fédération dentaire internationale (FDI) criteria for dental restorations.
T: 1 year. S: Randomized controlled Trial (split mouth design). Research question:In high caries risk patients with class I cavities will glass ionomer with glass hybrid technology has similar clinical performance as conventional high viscosity glass ionomer
- Conditions
- Class I Cavities in High Caries Risk
- Being tested
- Conventional high viscosity glass ionomer, Glass ionomer with glass hybrid technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional high viscosity glass ionomerOther
Also called GC EQUIA
Dental restorative material
Glass ionomer with glass hybrid technologyOther
Also called GC EQUIA Forte
Dental restorative material
| Study group | Role | What they receive |
|---|---|---|
| Glass Ionomer with Glass Hybrid technology | Experimental | Intervention Receives: Other: Glass ionomer with glass hybrid technology |
| Conventional high viscosity Glass Ionomer | Active comparator | Comparator Receives: Other: Conventional high viscosity glass ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance using FDI criteria for dental restorations (functional properties and biological properties)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Primary completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class I Cavities in High Caries RiskStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Refaat El-Bialy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856932
- Sponsor's protocol ID
- CEBD-CU-2016-08-178
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02856932
- Acronym / sponsor ID
- CEBD-CU-2016-08-178
- Conditions
- Class I Cavities in High Caries Risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Primary completion
- Sep 2018 (estimated)
- First posted
- 5 Aug 2016 (estimated)
- 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.
PICOTS:
P: High Caries Risk Patients with bilateral class I cavities. I: Glass Ionomer with Glass Hybrid Technology. C: Conventional High Viscosity Glass Ionomer. O: Clinical performance (Functional properties Biological properties) using (World Dental Federation) Fédération dentaire internationale (FDI) criteria for dental restorations.
T: 1 year. S: Randomized controlled Trial (split mouth design). Research question:In high caries risk patients with class I cavities will glass ionomer with glass hybrid technology has similar clinical performance as conventional high viscosity glass ionomer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glass Ionomer with Glass Hybrid technology | Experimental | Other: Glass ionomer with glass hybrid technologyIntervention |
| Conventional high viscosity Glass Ionomer | Active comparator | Other: Conventional high viscosity glass ionomerComparator |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Bilateral class I carious lesions in their occlusal pits and fissures.
- High caries risk patients who has 1 or more cavitated lesion with risk factor declared by Caries Management By Risk Assessment (CAMBRA)
- Co-operative patients approving to participate in the trial.
Key exclusion criteria (4 listed)
- Disabilities.
- Systemic diseases or severe medically compromised.
- Lack of compliance.
- Evidence of severe bruxism, clenching or temporomandibular joint disorders
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 |
|---|---|---|
| Conventional high viscosity glass ionomerAlso: GC EQUIADental restorative material | Other | Conventional high viscosity Glass Ionomer |
| Glass ionomer with glass hybrid technologyAlso: GC EQUIA ForteDental restorative material | Other | Glass Ionomer with Glass Hybrid technology |
Primary outcome
Clinical performance using FDI criteria for dental restorations (functional properties and biological properties)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
Related trials for Class I Cavities in High Caries Risk
Not yet recruiting
The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities (Randomized)
Class I Cavities in High Caries Risk, Class I Composite Restorations
Not yet recruiting
Clinical Evaluation of Bioactive Resin Composites Versus Caries Control Technique in Management of Class I Carious Cavities in High Caries Risk Patients: a Randomized Clinical Trial
High Caries Risk Patients
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 Conventional high viscosity glass ionomer and Glass ionomer with glass hybrid technology in people with Class I Cavities in High Caries Risk, 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 3 inclusion and 4 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 5 Aug 2016. 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 Mohamed R El-Bialy, Assistant lecturer (+201202552666, M.refaat.op@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance using FDI criteria for dental restorations (functional properties and biological properties) (time frame: 1 year). 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 5 Aug 2016.