Natural Optical PropertiesNCT03813628
Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Celtra Press Treated With Different Surface Finishing Protocols
A study testing polished celtra press full coverage crown, glazed celtra press full coverage crowns and contralateral natural teeth in people with Natural Optical Properties, run by Cairo University.
Trial summary
investigating the effect of glazing and polishing on the color difference between natural teeth and all ceramic crowns made from celtra press (zirconia reinforced lithium silicate ceramic). Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Natural Optical Properties
- What is being tested?
- polished celtra press full coverage crown, glazed celtra press full coverage crowns and contralateral natural teeth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Dec 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range of the patients from 20-45 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
- Patients able physically and psychologically to tolerate conventional restorative procedures.
- Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
- Patients with teeth problems indicated for full coverage restoration ( coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
- Patients with root canal treated teeth requiring full coverage restorations with contralatral tooth not filled or fractured.
- Patients 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's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
- Patients with psychiatric problems or unrealistic expectation
- Deep discoloration of abutment .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Zirconia Reinforced Lithium Silicate Ceramics "Celtra Press" Treated With Different Surface Finishing Protocols.
investigating the effect of glazing and polishing on the color difference between natural teeth and all ceramic crowns made from celtra press (zirconia reinforced lithium silicate ceramic).
Read the detailed description
Two groups of patients will be selected according to special inclusion criteria N=5 in each group total of 10 patients, one of the two groups will receive a glazed zirconia reinforced lithium silicate ''celtra press'' crowns and the other group will receive a polished ones of the same material , after crowns delivery color difference (ΔE) between the natural teeth and the celtra press crown will be measured by a spectrophotometer device (intra oral) and patient satisfaction will be recorded.
- Conditions
- Natural Optical Properties
- Being tested
- polished celtra press full coverage crown, glazed celtra press full coverage crowns, contralateral natural teeth
- Keywords
- celtra press
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polished celtra press full coverage crownOther
Also called polished all ceramic crown
a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing
glazed celtra press full coverage crownsOther
Also called glazed all ceramic crown
a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing
contralateral natural teethOther
the polished and glazed all ceramic crowns will be compared by the contralateral natural teeth
| Study group | Role | What they receive |
|---|---|---|
| polished celtra press full coverage crowns | Experimental | a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing Receives: Other: polished celtra press full coverage crown |
| glazed celtra press full coverage crowns | Experimental | a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing Receives: Other: glazed celtra press full coverage crowns |
| contralateral natural teeth | Active comparator | the poilshed and glazed all ceramic crowns will be compared by the contralateral natural teeth Receives: Other: contralateral natural teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
color match
Color match will be measured using "United states pulplic health service " system .
Scale system :
- Alpha : Excellent colour match and shade between restoration and adjacent tooth, restoration almost invisible
- Bravo : Slightly mismatching between the restoration and the adjacent tooth, which is in the normal range of tooth colour, translucence, and/or shade
- Charlie : Obvious mismatch, beyond the normal range
- Delta : Gross mismatch/aesthetically displeasing colour, shade, and/or translucence
Measured: immediately after crown delivery
Secondary outcomes (1)
Color difference
The color difference (ΔE) will be measured using spectrophotometer
Measured: immediately after crown delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study startMar 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Natural Optical PropertiesStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhan Sayed Saleh Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813628
- Sponsor's protocol ID
- CEBD-CU-2018-09-23
- Status last verified
- Mar 2019
- First submitted
- 17 Jan 2019
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Zirconia Reinforced Lithium Silicate Ceramics "Celtra Press" Treated With Different Surface Finishing Protocols.
- ClinicalTrials.gov ID
- NCT03813628
- Acronym / sponsor ID
- CEBD-CU-2018-09-23
- Conditions
- Natural Optical Properties
- Keywords
- celtra press
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Jan 2019 (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.
investigating the effect of glazing and polishing on the color difference between natural teeth and all ceramic crowns made from celtra press (zirconia reinforced lithium silicate ceramic).
Detailed description
Two groups of patients will be selected according to special inclusion criteria N=5 in each group total of 10 patients, one of the two groups will receive a glazed zirconia reinforced lithium silicate ''celtra press'' crowns and the other group will receive a polished ones of the same material , after crowns delivery color difference (ΔE) between the natural teeth and the celtra press crown will be measured by a spectrophotometer device (intra oral) and patient satisfaction will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| polished celtra press full coverage crowns | Experimental | Other: polished celtra press full coverage crowna full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing |
| glazed celtra press full coverage crowns | Experimental | Other: glazed celtra press full coverage crownsa full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing |
| contralateral natural teeth | Active comparator | Other: contralateral natural teeththe poilshed and glazed all ceramic crowns will be compared by the contralateral natural teeth |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age range of the patients from 20-45 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
- Patients able physically and psychologically to tolerate conventional restorative procedures.
- Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
- Patients with teeth problems indicated for full coverage restoration ( coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
- Patients with root canal treated teeth requiring full coverage restorations with contralatral tooth not filled or fractured.
Key exclusion criteria (5 listed)
- Patients in the growth stage with partially erupted teeth.
- Patients with poor oral hygiene and motivation.
- Pregnant women's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
- Patients with psychiatric problems or unrealistic expectation
- Deep discoloration of abutment .
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 celtra press full coverage crownAlso: polished all ceramic crowna full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing | Other | polished celtra press full coverage crowns |
| glazed celtra press full coverage crownsAlso: glazed all ceramic crowna full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing | Other | glazed celtra press full coverage crowns |
| contralateral natural teeththe polished and glazed all ceramic crowns will be compared by the contralateral natural teeth | Other | contralateral natural teeth |
Primary outcome
color match
Time frame: immediately after crown delivery
Color match will be measured using "United states pulplic health service " system . Scale system : * Alpha : Excellent colour match and shade between restoration and adjacent tooth, restoration almost invisible * Bravo : Slightly mismatching between the restoration and the adjacent tooth, which is in the normal range of tooth colour, translucence, and/or shade * Charlie : Obvious mismatch, beyond the normal range * Delta : Gross mismatch/aesthetically displeasing colour, shade, and/or translucence
1 secondary outcome
Color difference
Time frame: immediately after crown delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Natural Optical Properties
Not yet recruiting
Clinical Evaluation and Patient Satisfaction of Shade Matching Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Two Materials
Natural Optical Properties
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.
Questions about this trial
What is this clinical trial studying?
A study testing polished celtra press full coverage crown, glazed celtra press full coverage crowns and contralateral natural teeth in people with Natural Optical Properties, 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 6 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: status not confirmed, as of the sponsor's last update on 4 Mar 2019. 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 nourhan sayed (01117911384, nourhan.sayed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
color match (time frame: immediately after crown delivery). 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 4 Mar 2019.