Color Change of Lithium Disilicate CrownsNCT03696641
Clinical Assessment of Color Stability and Patient Satisfaction for Polished Versus Glazed Lithium Disilicate Glass Ceramic Restorations and Patient Satisfaction
A study testing glazed lithium disilicate crowns and polished lithium disilicate crowns in people with Color Change of Lithium Disilicate Crowns, run by Cairo University.
Trial summary
Dental overglaze is consist of colorless glass powder and applied to the fired crown surface to provide a glossy surface,Adjustment procedure break the production of the glaze layer through a natural glaze or overglaze process and create a rough surface, glazing or polishing after adjustment procedures is important to… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Color Change of Lithium Disilicate Crowns
- What is being tested?
- glazed lithium disilicate crowns and polished lithium disilicate crowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 1 Nov 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All subjects are required to be:
- From 18-50 years old, be 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
- Willing to return for follow-up examinations and evaluation
Who cannot join
- 1. Patients in the growth stage with partially erupted teeth 2. Patients with poor oral hygiene and motivation 3. Pregnant women's 4. Psychiatric problems or unrealistic expectations
Trial locations and contacts
No sites are listed yet.
Hesham katamish, professor contact
About this study
Dental overglaze is consist of colorless glass powder and applied to the fired crown surface to provide a glossy surface,Adjustment procedure break the production of the glaze layer through a natural glaze or overglaze process and create a rough surface, glazing or polishing after adjustment procedures is important to enhance the appearance of the restoration
Read the detailed description
Dental overglaze is consist of colorless glass powder and applied to the fired crown surface to provide a glossy surface. Natural glaze is a vitrified layer that is formed on the surface of the porcelain containing a glass phase when the porcelain is heated to a glazing temperature for a specific time, Adjustment procedure break the production of the glaze layer through a natural glaze or overglaze process and create a rough surface, The color of porcelain restorations is affected by surface roughness because rough surface reflects light irregularly and less than a glazed surface . Therefore, glazing or polishing after adjustment procedures is important to enhance the appearance of the restoration .
Although glazed surfaces appeared whiter, the CIE L* value measured with the specular component excluded (SCE) geometry was lower than that of polished surfaces (28).Several reports have investigated different polishing techniques that support the use of polishing as an alternative for glazing of ceramic restorations .
Polishing can reduce chair time, eliminates laboratory procedures, infection control may be obtained . Polishing is also important for the porcelain surface for esthetic so several different techniques have been described for repolishing porcelain surfaces in the mouth .
- Being tested
- glazed lithium disilicate crowns, polished lithium disilicate crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glazed lithium disilicate crownsOther
Also called glazed IPS e.max
glazing of IPS e.max crowns
polished lithium disilicate crownsOther
Also called polished IPS e.max
polishing of IPS e.max crowns
| Study group | Role | What they receive |
|---|---|---|
| glazed IPS e.max | Active comparator | lithium disilicate glazed crowns that proved to have a good color stability Receives: Other: glazed lithium disilicate crowns; Other: polished lithium disilicate crowns |
| polished IPS e.max | Experimental | polished lithium disilicate crowns with the polishing kit Receives: Other: glazed lithium disilicate crowns; Other: polished lithium disilicate crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
color stability
L* a* b* values and ∆E
Measured: one year
Secondary outcomes (1)
patient satisfaction
patient satisfaction through a questionnaire
Measured: one 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 start1 Nov 2018 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Color Change of Lithium Disilicate CrownsStudies 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
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Sayed Mosallam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696641
- Sponsor's protocol ID
- CEBD-CU-2018-09-25
- Status last verified
- Oct 2018
- First submitted
- 3 Oct 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Color Stability and Patient Satisfaction for Polished Versus Glazed Lithium Disilicate Glass Ceramic Restorations and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT03696641
- Acronym / sponsor ID
- CEBD-CU-2018-09-25
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Nov 2019 (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.
Dental overglaze is consist of colorless glass powder and applied to the fired crown surface to provide a glossy surface,Adjustment procedure break the production of the glaze layer through a natural glaze or overglaze process and create a rough surface, glazing or polishing after adjustment procedures is important to enhance the appearance of the restoration
Detailed description
Dental overglaze is consist of colorless glass powder and applied to the fired crown surface to provide a glossy surface. Natural glaze is a vitrified layer that is formed on the surface of the porcelain containing a glass phase when the porcelain is heated to a glazing temperature for a specific time, Adjustment procedure break the production of the glaze layer through a natural glaze or overglaze process and create a rough surface, The color of porcelain restorations is affected by surface roughness because rough surface reflects light irregularly and less than a glazed surface . Therefore, glazing or polishing after adjustment procedures is important to enhance the appearance of the restoration .
Although glazed surfaces appeared whiter, the CIE L* value measured with the specular component excluded (SCE) geometry was lower than that of polished surfaces (28).Several reports have investigated different polishing techniques that support the use of polishing as an alternative for glazing of ceramic restorations .
Polishing can reduce chair time, eliminates laboratory procedures, infection control may be obtained . Polishing is also important for the porcelain surface for esthetic so several different techniques have been described for repolishing porcelain surfaces in the mouth .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glazed IPS e.max | Active comparator | Other: glazed lithium disilicate crowns, Other: polished lithium disilicate crownslithium disilicate glazed crowns that proved to have a good color stability |
| polished IPS e.max | Experimental | Other: glazed lithium disilicate crowns, Other: polished lithium disilicate crownspolished lithium disilicate crowns with the polishing kit |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All subjects are required to be:
Key exclusion criteria (1 listed)
- 1. Patients in the growth stage with partially erupted teeth 2. Patients with poor oral hygiene and motivation 3. Pregnant women's 4. Psychiatric problems or unrealistic expectations
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 |
|---|---|---|
| glazed lithium disilicate crownsAlso: glazed IPS e.maxglazing of IPS e.max crowns | Other | glazed IPS e.max, polished IPS e.max |
| polished lithium disilicate crownsAlso: polished IPS e.maxpolishing of IPS e.max crowns | Other | glazed IPS e.max, polished IPS e.max |
Primary outcome
color stability
Time frame: one year
L* a* b* values and ∆E
1 secondary outcome
patient satisfaction
Time frame: one 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.
- Individual participant dataSharing planned: No
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.
Hesham katamish, professor contact
Questions about this trial
What is this clinical trial studying?
A study testing glazed lithium disilicate crowns and polished lithium disilicate crowns in people with Color Change of Lithium Disilicate Crowns, 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 5 inclusion and 1 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 rasha sayed MOSALLAM, MDS (01004222871, rashamosallam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
color stability (time frame: one 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.