Tooth DecayNCT03696849
Clinical Assessement of Glazed Versus Polished Lithium Disilicate Crowns in Surface Roughness and Enamel Antagonists Wear
A study testing polished emax Press in people with Tooth Decay, run by Cairo University.
Trial summary
It is believed that final glazing yields the most acceptable ceramic surfaces in terms of smoothness. However, since reglazing must be performed in a dental laboratory with the use of a thermal furnace, it requires multiple office visits. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tooth Decay
- What is being tested?
- polished emax Press
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Jan 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients from 18-50 years old who are able to read and sign the informed consent document.
- Physically and psychologically able to tolerate conventional restorative procedures.
- Have no active periodontal or pulpal diseases, have teeth with good restorations.
- Patients have no temporomandibular disorders.
- Each participant needed a crown on either a first or second premolar or first or second molar in any arch.
- Teeth selected shoud include:
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- restorability with a crown:root ratio of at least 1:1. presence of an opposing natural tooth which was non-restored or minimally restored.
- the presence of two non-restored or minimally restored teeth opposing each other on the same quadrants as the crowned tooth and the opposing to serve as enamel controls. Minimally restored was defined as teeth which have no restoration greater than a Class II amalgam restoration.
- Willing to return for follow-up examinations and evaluation.
Who cannot join
- Patients in the growth stage with partially erupted teeth.
- Patients with poor oral hygiene and motivation.
- Pregnant women.
- Psychiatric problems or unrealistic expectations.
- Lack of opposite occluding dentition in the area intended for restoration.
- Patients with temporomandibular disorders.
Trial locations and contacts
No sites are listed yet.
Lamia Khair Allah contact
About this study
Official title: Patient Satisfaction and Clinical Assessment of Surface Roughness and Wear of Enamel Antagonists for Polished Versus Glazed Posterior Lithium Disilicate Glass Ceramic Crowns
It is believed that final glazing yields the most acceptable ceramic surfaces in terms of smoothness. However, since reglazing must be performed in a dental laboratory with the use of a thermal furnace, it requires multiple office visits. Repeated firings have a destructive effect on ceramic surfaces and can cause deformation. Conversely, polishing is easy and simple and can be accomplished in a single session.
- Conditions
- Tooth Decay
- Being tested
- polished emax Press
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polished emax PressOther
Also called emaxPressable ceramics
lithium disilicate glass ceramic crowns subjected to polishing only
| Study group | Role | What they receive |
|---|---|---|
| glazed emax Press | Active comparator | Not described Receives: Other: polished emax Press |
| Polished emax Press | Experimental | Not described Receives: Other: polished emax Press |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antagonists enamel wear using profilometer
wear of enamel antagonists opposing to emaxPress crowns that will be measured in um
Measured: 1 year
Secondary outcomes (2)
Restoration surface Roughness using profilometer
restoration roughness after different finishing methods that will me measured in um
Measured: 1 year
Patient satisfaction
Questionnaire
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 Oct 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DecayStudies 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mervat Mourad Rouchdy Farid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696849
- Sponsor's protocol ID
- CEBD-CU-2018-09-34
- Status last verified
- Oct 2018
- First submitted
- 2 Oct 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Clinical Assessment of Surface Roughness and Wear of Enamel Antagonists for Polished Versus Glazed Posterior Lithium Disilicate Glass Ceramic Crowns
- ClinicalTrials.gov ID
- NCT03696849
- Acronym / sponsor ID
- CEBD-CU-2018-09-34
- Conditions
- Tooth Decay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 5 Oct 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.
It is believed that final glazing yields the most acceptable ceramic surfaces in terms of smoothness. However, since reglazing must be performed in a dental laboratory with the use of a thermal furnace, it requires multiple office visits. Repeated firings have a destructive effect on ceramic surfaces and can cause deformation. Conversely, polishing is easy and simple and can be accomplished in a single session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glazed emax Press | Active comparator | Other: polished emax Press |
| Polished emax Press | Experimental | Other: polished emax Press |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients from 18-50 years old who are able to read and sign the informed consent document.
- Physically and psychologically able to tolerate conventional restorative procedures.
- Have no active periodontal or pulpal diseases, have teeth with good restorations.
- Patients have no temporomandibular disorders.
- Each participant needed a crown on either a first or second premolar or first or second molar in any arch.
Key exclusion criteria (6 listed)
- Patients in the growth stage with partially erupted teeth.
- Patients with poor oral hygiene and motivation.
- Pregnant women.
- Psychiatric problems or unrealistic expectations.
- Lack of opposite occluding dentition in the area intended for restoration.
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 |
|---|---|---|
| polished emax PressAlso: emaxPressable ceramicslithium disilicate glass ceramic crowns subjected to polishing only | Other | Polished emax Press, glazed emax Press |
Primary outcome
Antagonists enamel wear using profilometer
Time frame: 1 year
wear of enamel antagonists opposing to emaxPress crowns that will be measured in um
2 secondary outcomes
Restoration surface Roughness using profilometer
Time frame: 1 year
Patient satisfaction
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 Oct 2018.
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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.
Lamia Khair Allah contact
Questions about this trial
What is this clinical trial studying?
A study testing polished emax Press in people with Tooth Decay, 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 9 inclusion and 6 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 Oct 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 Mervat Rouchdy, M.D.s (01272625020, mervatmourad82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antagonists enamel wear using profilometer (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 Oct 2018.