Personal SatisfactionNCT02846116
Evaluation of Patient Satisfaction and Shade Matching of Vita Suprinity Versus Lithium Disilicate (E-max) Ceramic Crowns in Esthetic Zone
A study testing Prosthetic crown in people with Personal Satisfaction, run by Cairo University.
Trial summary
The aim of this study is to evaluate using of new ceramic material Vita Suprinity and lithium disilicate on patient satisfaction combined with shade matching. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Personal Satisfaction
- What is being tested?
- Prosthetic crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jul 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range of the patients from 20-60 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 (e.g. mild to moderate discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
- Patients with root canal treated teeth requiring full coverage restorations.
- 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 (patient that has phobia from dental treatments or needle bunch).
- Patients have no opposite occluding dentition in the area intended for restoration.
- Patients suffer from parafunctional habits.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to evaluate using of new ceramic material Vita Suprinity and lithium disilicate on patient satisfaction combined with shade matching.
Read the detailed description
Justification for undertaking the trial:
Nowadays, esthetics has become an important aspect of dentistry due to decrease in caries prevalence and increase in patients' perception of their teeth appearance. Therefore dentists should take into consideration the esthetic needs of the patients during treatment, otherwise patient satisfaction will not be achieved with its subsequent influence on patient self quality of life and psychological status.
As a survey concerning patient satisfaction with regard to dental esthetics issues concluded that color of the restoration plays a primary role for patient satisfaction, as 89.3% of patients were dissatisfied of their dental appearance because of their restorations' color.
Therefore the use of ceramic crowns has increased substantially in recent years because of their superior esthetics and color rendering. In addition to their ability to achieve complete patient satisfaction.
Rationale:
Achieving good esthetic results especially with the continuous innovations of dental ceramic materials is not always easy to achieve and the definitive shade match of porcelain restorations to natural dentition remains a challenge to the dental practitioners and ceramists. Furthermore patient satisfaction to the final outcome is not always in agreement with the clinicians in regard to shade matching decisions.
Therefore this study will be conducted to evaluate patient satisfaction and shade matching of Vita suprinity versus e-max all ceramic crowns in esthetic zone.
Benefits of the research to the patient:
Patient will receive a restoration with superior esthetics, shade match and quality.
It will provide the patient with long-term predictable esthetic restorations As a result of unnoticed perfect esthetic restoration, the patient will be psychologically improved.
Benefits of the research to the clinician:
Practitioner will have the advantage to assess a new material that can be used in different situations for better esthetic outcomes.
It will improve patient confidence with the dentist. It will improve professional skills of the dentist to achieve optimum esthetic results.
Explanation for choice of comparators:
The use of IPS e.max Press is well documented in the literatures as successful restoration modality. A three-year clinical evaluation of two ceramic crown systems revealed excellent color match for the IPS e-max crowns (Alpha for 24 crowns and Bravo for 6 crowns with slight shade mismatches). Also patient questionnaire revealed satisfaction with the appearance and comfort of their restorations.
A 2 years prospective clinical observation study reported Alpha scores (greater than 92%) indicating no appreciable change in the crowns during the two years of the study.
Also the clinical performance of lithium disilicate pressable ceramic crowns revealed a survival rate of 97.4 % after 5 years and 94.8 % after 8 years as reported by Gehrt et al., (2013).
Another 2 years clinical evaluation of lithium disilicate based all ceramic crowns revealed satisfactory clinical performance, with color match Alpha (85%) at baseline, 80% at 1 year recall and 60 % at 2 years recall.
Research hypothesis:
There is difference in the clinical performance of Vita Suprinity if compared with Lithium disilicate ceramic crown restoration if used in esthetic zone.
Interventions:
VITA SUPRINITY: Vita suprinity product Brochure presented a new generation of glass ceramic material. With the aid of an innovative manufacturing process, the glass ceramic is enriched with approximately 10% zirconia by weight, resulting in the world's first zirconia reinforced lithium silicate ceramic (ZLS). The material features a special fine-grained, homogeneous structure that provides excellent material quality and consistency, high load capacity and long term reliability. Moreover, the material offers natural esthetics with successful outcome. Also it offers outstanding processing characteristics, including easy milling and polishing.
- Conditions
- Personal Satisfaction
- Being tested
- Prosthetic crown
- Keywords
- all ceramic crown, Lithium disilicate, e-max, vita suprinity
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic crownOther
Also called all ceramic crown
| Study group | Role | What they receive |
|---|---|---|
| lithium disilicate | Active comparator | The intervention will be: Prosthetic crown Receives: Other: Prosthetic crown |
| Vita suprinity | Active comparator | The intervention will be: Prosthetic crown Receives: Other: Prosthetic crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)
Measured: 1 year
Secondary outcomes (1)
Shade matchUsing the modified United States Public Health Service criteria (Modified USPHS)- categorical
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 posted27 Jul 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Personal SatisfactionStudies 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abou-steit, Cairo University
- Investigators
- Amina Zaki, Professor, Study director, Faculty of Oral and Dental Medicine- Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846116
- Sponsor's protocol ID
- CEBD-2016-7-170
- Status last verified
- Oct 2016
- First submitted
- 19 Jul 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Tin-Oo MM, Saddki N, Hassan N. Factors influencing patient satisfaction with dental appearance and treatments they desire to improve aesthetics. BMC Oral Health. 2011 Feb 23;11:6. doi: 10.1186/1472-6831-11-6.
PubMed 21342536Batson ER, Cooper LF, Duqum I, Mendonca G. Clinical outcomes of three different crown systems with CAD/CAM technology. J Prosthet Dent. 2014 Oct;112(4):770-7. doi: 10.1016/j.prosdent.2014.05.002. Epub 2014 Jun 28.
PubMed 24980739John MT, Slade GD, Szentpetery A, Setz JM. Oral health-related quality of life in patients treated with fixed, removable, and complete dentures 1 month and 6 to 12 months after treatment. Int J Prosthodont. 2004 Sep-Oct;17(5):503-11.
PubMed 15543905Grossmann AC, Hassel AJ, Schilling O, Lehmann F, Koob A, Rammelsberg P. Treatment with double crown-retained removable partial dentures and oral health-related quality of life in middle- and high-aged patients. Int J Prosthodont. 2007 Nov-Dec;20(6):576-8.
PubMed 18069364Corciolani G, Vichi A, Louca C, Ferrari M. Color match of two different ceramic systems to selected shades of one shade guide. J Prosthet Dent. 2011 Mar;105(3):171-6. doi: 10.1016/S0022-3913(11)60025-5.
PubMed 21356409Ishikawa-Nagai S, Yoshida A, Sakai M, Kristiansen J, Da Silva JD. Clinical evaluation of perceptibility of color differences between natural teeth and all-ceramic crowns. J Dent. 2009;37 Suppl 1:e57-63. doi: 10.1016/j.jdent.2009.04.004. Epub 2009 Apr 18.
PubMed 19423209Al-Wahadni A, Ajlouni R, Al-Omari Q, Cobb D, Dawson D. Shade-match perception of porcelain-fused-to-metal restorations: a comparison between dentist and patient. J Am Dent Assoc. 2002 Sep;133(9):1220-5; quiz 1260-1. doi: 10.14219/jada.archive.2002.0363.
PubMed 12356253Etman MK, Woolford MJ. Three-year clinical evaluation of two ceramic crown systems: a preliminary study. J Prosthet Dent. 2010 Feb;103(2):80-90. doi: 10.1016/S0022-3913(10)60010-8.
PubMed 20141812Dr Rupal J Shah1. A Study of Patient Satisfaction with Maxillary Anterior Teeth Restorations and Desirable Esthetic Treatment Options\n. IOSR J. Dent. Med. Sci. 13, 79-86 (2014).
Samorodnitzky-Naveh GR, Geiger SB, Levin L. Patients' satisfaction with dental esthetics. J Am Dent Assoc. 2007 Jun;138(6):805-8. doi: 10.14219/jada.archive.2007.0269.
PubMed 17545270
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Satisfaction and Shade Matching of Vita Suprinity Versus Lithium Disilicate (E-max) Ceramic Crowns in Esthetic Zone
- ClinicalTrials.gov ID
- NCT02846116
- Acronym / sponsor ID
- CEBD-2016-7-170
- Conditions
- Personal Satisfaction
- Keywords
- all ceramic crown, Lithium disilicate, e-max, vita suprinity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 27 Jul 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.
The aim of this study is to evaluate using of new ceramic material Vita Suprinity and lithium disilicate on patient satisfaction combined with shade matching.
Detailed description
Justification for undertaking the trial:
Nowadays, esthetics has become an important aspect of dentistry due to decrease in caries prevalence and increase in patients' perception of their teeth appearance. Therefore dentists should take into consideration the esthetic needs of the patients during treatment, otherwise patient satisfaction will not be achieved with its subsequent influence on patient self quality of life and psychological status.
As a survey concerning patient satisfaction with regard to dental esthetics issues concluded that color of the restoration plays a primary role for patient satisfaction, as 89.3% of patients were dissatisfied of their dental appearance because of their restorations' color.
Therefore the use of ceramic crowns has increased substantially in recent years because of their superior esthetics and color rendering. In addition to their ability to achieve complete patient satisfaction.
Rationale:
Achieving good esthetic results especially with the continuous innovations of dental ceramic materials is not always easy to achieve and the definitive shade match of porcelain restorations to natural dentition remains a challenge to the dental practitioners and ceramists. Furthermore patient satisfaction to the final outcome is not always in agreement with the clinicians in regard to shade matching decisions.
Therefore this study will be conducted to evaluate patient satisfaction and shade matching of Vita suprinity versus e-max all ceramic crowns in esthetic zone.
Benefits of the research to the patient:
Patient will receive a restoration with superior esthetics, shade match and quality.
It will provide the patient with long-term predictable esthetic restorations As a result of unnoticed perfect esthetic restoration, the patient will be psychologically improved.
Benefits of the research to the clinician:
Practitioner will have the advantage to assess a new material that can be used in different situations for better esthetic outcomes.
It will improve patient confidence with the dentist. It will improve professional skills of the dentist to achieve optimum esthetic results.
Explanation for choice of comparators:
The use of IPS e.max Press is well documented in the literatures as successful restoration modality. A three-year clinical evaluation of two ceramic crown systems revealed excellent color match for the IPS e-max crowns (Alpha for 24 crowns and Bravo for 6 crowns with slight shade mismatches). Also patient questionnaire revealed satisfaction with the appearance and comfort of their restorations.
A 2 years prospective clinical observation study reported Alpha scores (greater than 92%) indicating no appreciable change in the crowns during the two years of the study.
Also the clinical performance of lithium disilicate pressable ceramic crowns revealed a survival rate of 97.4 % after 5 years and 94.8 % after 8 years as reported by Gehrt et al., (2013).
Another 2 years clinical evaluation of lithium disilicate based all ceramic crowns revealed satisfactory clinical performance, with color match Alpha (85%) at baseline, 80% at 1 year recall and 60 % at 2 years recall.
Research hypothesis:
There is difference in the clinical performance of Vita Suprinity if compared with Lithium disilicate ceramic crown restoration if used in esthetic zone.
Interventions:
VITA SUPRINITY: Vita suprinity product Brochure presented a new generation of glass ceramic material. With the aid of an innovative manufacturing process, the glass ceramic is enriched with approximately 10% zirconia by weight, resulting in the world's first zirconia reinforced lithium silicate ceramic (ZLS). The material features a special fine-grained, homogeneous structure that provides excellent material quality and consistency, high load capacity and long term reliability. Moreover, the material offers natural esthetics with successful outcome. Also it offers outstanding processing characteristics, including easy milling and polishing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lithium disilicate | Active comparator | Other: Prosthetic crownThe intervention will be: Prosthetic crown |
| Vita suprinity | Active comparator | Other: Prosthetic crownThe intervention will be: Prosthetic crown |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age range of the patients from 20-60 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 (e.g. mild to moderate discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
- Patients with root canal treated teeth requiring full coverage restorations.
Key exclusion criteria (6 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 (patient that has phobia from dental treatments or needle bunch).
- Patients have no 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 |
|---|---|---|
| Prosthetic crownAlso: all ceramic crown | Other | Vita suprinity, lithium disilicate |
Primary outcome
Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)
Time frame: 1 year
1 secondary outcome
Shade matchUsing the modified United States Public Health Service criteria (Modified USPHS)- categorical
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 18 Oct 2016.
- Background: PubMed 21342536Tin-Oo MM, Saddki N, Hassan N. Factors influencing patient satisfaction with dental appearance and treatments they desire to improve aesthetics. BMC Oral Health. 2011 Feb 23;11:6. doi: 10.1186/1472-6831-11-6.
- Background: PubMed 24980739Batson ER, Cooper LF, Duqum I, Mendonca G. Clinical outcomes of three different crown systems with CAD/CAM technology. J Prosthet Dent. 2014 Oct;112(4):770-7. doi: 10.1016/j.prosdent.2014.05.002. Epub 2014 Jun 28.
- Background: PubMed 15543905John MT, Slade GD, Szentpetery A, Setz JM. Oral health-related quality of life in patients treated with fixed, removable, and complete dentures 1 month and 6 to 12 months after treatment. Int J Prosthodont. 2004 Sep-Oct;17(5):503-11.
- Background: PubMed 18069364Grossmann AC, Hassel AJ, Schilling O, Lehmann F, Koob A, Rammelsberg P. Treatment with double crown-retained removable partial dentures and oral health-related quality of life in middle- and high-aged patients. Int J Prosthodont. 2007 Nov-Dec;20(6):576-8.
- Background: PubMed 21356409Corciolani G, Vichi A, Louca C, Ferrari M. Color match of two different ceramic systems to selected shades of one shade guide. J Prosthet Dent. 2011 Mar;105(3):171-6. doi: 10.1016/S0022-3913(11)60025-5.
- Background: PubMed 19423209Ishikawa-Nagai S, Yoshida A, Sakai M, Kristiansen J, Da Silva JD. Clinical evaluation of perceptibility of color differences between natural teeth and all-ceramic crowns. J Dent. 2009;37 Suppl 1:e57-63. doi: 10.1016/j.jdent.2009.04.004. Epub 2009 Apr 18.
- Background: PubMed 12356253Al-Wahadni A, Ajlouni R, Al-Omari Q, Cobb D, Dawson D. Shade-match perception of porcelain-fused-to-metal restorations: a comparison between dentist and patient. J Am Dent Assoc. 2002 Sep;133(9):1220-5; quiz 1260-1. doi: 10.14219/jada.archive.2002.0363.
- Background: PubMed 20141812Etman MK, Woolford MJ. Three-year clinical evaluation of two ceramic crown systems: a preliminary study. J Prosthet Dent. 2010 Feb;103(2):80-90. doi: 10.1016/S0022-3913(10)60010-8.
- BackgroundDr Rupal J Shah1. A Study of Patient Satisfaction with Maxillary Anterior Teeth Restorations and Desirable Esthetic Treatment Options\n. IOSR J. Dent. Med. Sci. 13, 79-86 (2014).
- Results publication: PubMed 17545270Samorodnitzky-Naveh GR, Geiger SB, Levin L. Patients' satisfaction with dental esthetics. J Am Dent Assoc. 2007 Jun;138(6):805-8. doi: 10.14219/jada.archive.2007.0269.
- Individual participant dataSharing planned: Undecided
Related trials for Personal Satisfaction
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Recruiting
Effects of Red Panax Ginseng Supplementation on Cognitive Performance and Emotional Well-Being in Young Healthy Adults
Mental Acuity
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
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.
Amina Zaki, Professor study director
Faculty of Oral and Dental Medicine- Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic crown in people with Personal Satisfaction, 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 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 18 Oct 2016. 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 Sameh Sh Abou-Steit, Master (+201001891010, samehabousteit@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied) (time frame: 1 year). 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 NCT02846116, which also lists 10 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 18 Oct 2016.