Personal SatisfactionPhase 2NCT02929173
Effect of Different Types of Crowns on Patient Satisfaction and Clinical Assesment
A Phase 2 study testing Allceram and hybrid crown in people with Personal Satisfaction, run by Cairo University.
Trial summary
The aim of this study is to compare the patient satisfaction and clinical assessment (shade matching, surface texture and marginal discoloration) of Bio- High Performance Polymers (HPP) restoration versus E-max restoration compared to contralateral tooth in anterior zone. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Personal Satisfaction
- What is being tested?
- Allceram and hybrid crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Mar 2018
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient will be able to physically and psychologically to tolerate conventional restorative procedures.
- Patients have no active periodontal or pulpal diseases, have teeth with good restorations.
- Patient with anterior tooth with 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 are willing to return for follow-up examination and evaluation.
- Patient with sound contralateral tooth to the selected tooth required for full coverage.
- Patient with root canal treated tooth requiring full coverage restoration
Who cannot join
- Patient in the growth stage with partially erupted teeth.
- Patient with poor oral hygiene and motivation.
- Pregnant women's.
- Patient with psychiatric problems or unrealistic expectations.
- Patients have no opposing occluding dentition in the area intended for restoration.
- Patients with parafunctional habits.
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- Color blindness patients are excluded.
- Patient without contralateral tooth to that tooth to will be restored.
- Patient without adjacent teeth to that tooth will be restored.
About this study
Official title: Patient Satisfaction and Clinical Assessment of Biocompatible High Performance Polymers Crown Veneered With Visio.Lign Versus E-max Crown Veneered With E-max Veneering System in Anterior Aesthetic Zone.(Randomized Controlled Clinical Trial)
The aim of this study is to compare the patient satisfaction and clinical assessment (shade matching, surface texture and marginal discoloration) of Bio- High Performance Polymers (HPP) restoration versus E-max restoration compared to contralateral tooth in anterior zone.
Regardless E-max popularity in the dental field.
Read the detailed description
Roles and responsibilities
- Nora Helmy Hasaneen (N.H.): Operator, data enterer and corresponding author; Assistant lecturer fixed Prosthodontics Department, Faculty of Dentistry, Modern Technology Institution (MTI) University, Egypt.
- Dr. Ahmed Naguib Hussin( A.H.): Main supervisor, data monitoring and auditing; Professor of fixed Prosthodontics, Faculty of Oral and Dental Medicine- Cairo University, Egypt.
- Dr.Gihan Al-Naggar (A. G.):Co-Supervisor, data monitoring and auditing; Professor of fixed Prosthodontics, Faculty of Oral and Dental Medicine -Cairo University, Egypt.
3.Esraa Mohamed Odeuh(E.O.):Outcome assessors and data collection; Assistant lecturer, Fixed Prosthodontics Department, Faculty of Oral and Dental Medicine, MTI University, Egypt.
4.Ahmed Gamal(A.G): Base line data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants' consents; Resident Fixed Prosthodontics Department, Faculty of Oral and Dental Medicine, MTI University, Egypt.
5.Eman Desouky (E.D.):Sample size calculation; Statistician, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Evidence Based Dentistry Committee (CEBD) Help in reporting study protocol following SPIRIT guidelines; Faculty of Oral and Dental Medicine, Cairo University, Egypt.
7.Research Ethics Committee (CREC): Protocol reviewer of the clinical trial in order to protect the right, safety, dignity and well-being of the participants; Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Research Plan Committee (CRPC):For ensuring that this clinical trial following the department research plan; Fixed prosthodontic Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Intervention: N.H. will perform conservative tooth preparation following the principles of all ceramic crown preparation with shoulder subgingival finish line of thickness 1.2mm using tapered stone with flat end attached to high speed headpiece with air and water coolant, after local anesthesia has been given. N.H. will take adequate 2ry Impression using non aqueous Elastomeric impression materials Impregum™F (medium consistency, 3M ESPE ,) and bite registration will by pink soft wax (Stardentalsupply) . N.A. \& E.O. will visually select the shade match using Vita Easyshade Compact (Vita Zahnfabrik, Bad Sa¨ckingen,Germany). N.H will fabricate the temporary restoration using Protemp™ 4 Temporisation Material(3M ESPE ) and cemented using non Eugenol Zinc Oxide temporary cement TempBond™ Temporization (Kerrdentalsupply). N.H will deliver Press Bio - HPP framework material veneered with visio lign veneering material (Bredent) crown and cement it with 3M™ ESPE™ RelyX™ Unicem Self-Adhesive Universal Resin Cement.
- Comparator N.H. will perform conservative tooth preparation following the principles of all ceramic crown preparation with shoulder subgingival finish line of thickness 1.2mm using tapered stone with flat end attached to high speed headpiece with air and water coolant, after local anesthesia has been given. N.H. will take adequate 2ry Impression using non aqueous Elastomeric impression materials Impregum™F (medium consistency, 3M ESPE ,) and bite registration will by pink soft wax (Stardentalsupply) . N.A. \& E.O. will visually select the shade match using Vita Easyshade Compact (Vita Zahnfabrik, Bad Sa¨ckingen,Germany). N.H will fabricate the temporary restoration using Protemp™ 4 Temporisation Material(3M ESPE ) and cemented using non Eugenol Zinc Oxide temporary cement TempBond™ Temporization (Kerrdentalsupply). N.H will deliver E.max® framework veneered with E-max veneering System (Ivoclar Vivadent) crown and cement it with 3M™ ESPE™ RelyX™ Unicem Self-Adhesive Universal Resin Cement.
- Outcomes
- Primary outcome: Patient satisfaction:
E.O will measure patient satisfaction using Rating scores. The mean and standard deviation for the Rating scores of the patients will be recorded at the time of crown cementation, 3, 6, 9 \& 12 months after review for aesthetics.
- Secondary outcome: Clinical assessment of the restoration:
E.O will evaluate shade matching, marginal discoloration and surface texture using modified USPHS criteria scores. The mean and standard deviation for the USPHS criteria scores of the patients will be recorded at the time of crown cementation 0, 3, 6, 9 \& 12 months after review for aesthetics.
- Conditions
- Personal Satisfaction
- Being tested
- Allceram, hybrid crown
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllceramOther
Also called Prosthetic Crown
Pressed E-max coping veneered with E-max veneering system
hybrid crownOther
Also called Prosthetic Crown
pressed Bio HPP coping veneered with visolign veneering system
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Active comparator | E-max is un allceram crown Receives: Other: Allceram |
| Group 1 | Experimental | Bio HPP crown is a hybrid crown Receives: Other: hybrid crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in esthetic patient satisfaction
using Rating scores from 0-2 (0= Poor, 1=Accepted, 2=Excellent)
Measured: At crown delivery time and after delivery 3, 6, 9, 12 month
Secondary outcomes (3)
Shade match to contralateral tooth
using Modified USPHS scores from 0-3 (0= Match to contralateral tooth, 1=Acceptable mismatch to contralateral tooth , 2=Unacceptable mismatch to contralateral tooth, 3=New restoration is needed.)
Measured: At crown delivery time and after delivery 3, 6, 9, 12 month
Marginal discolouration
using Modified USPHS scores from 0-3 (0= Smooth surface., 1=Slight staining can be polished away., 2=Gross staining., 3=New restoration is needed.)
Measured: At crown delivery time and after delivery 3, 6, 9, 12 month
Surface texture
using Modified USPHS scores from 0-3 (0= Surface is smooth as the surrounding., 1=Surface is rough than the surrounding, 2=Gross staining., 3=Surface is very rough avoiding movement of the explorer, 4=New restoration is needed.)
Measured: At crown delivery time and after delivery 3, 6, 9, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora helmy hassaneen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929173
- Sponsor's protocol ID
- CEBD-CU-2016-09-217
- Status last verified
- Oct 2016
- First submitted
- 7 Oct 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Clinical Assessment of Biocompatible High Performance Polymers Crown Veneered With Visio.Lign Versus E-max Crown Veneered With E-max Veneering System in Anterior Aesthetic Zone.(Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT02929173
- Acronym / sponsor ID
- CEBD-CU-2016-09-217
- Conditions
- Personal Satisfaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 11 Oct 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 compare the patient satisfaction and clinical assessment (shade matching, surface texture and marginal discoloration) of Bio- High Performance Polymers (HPP) restoration versus E-max restoration compared to contralateral tooth in anterior zone.
Regardless E-max popularity in the dental field.
Detailed description
Roles and responsibilities
- Nora Helmy Hasaneen (N.H.): Operator, data enterer and corresponding author; Assistant lecturer fixed Prosthodontics Department, Faculty of Dentistry, Modern Technology Institution (MTI) University, Egypt.
- Dr. Ahmed Naguib Hussin( A.H.): Main supervisor, data monitoring and auditing; Professor of fixed Prosthodontics, Faculty of Oral and Dental Medicine- Cairo University, Egypt.
- Dr.Gihan Al-Naggar (A. G.):Co-Supervisor, data monitoring and auditing; Professor of fixed Prosthodontics, Faculty of Oral and Dental Medicine -Cairo University, Egypt.
3.Esraa Mohamed Odeuh(E.O.):Outcome assessors and data collection; Assistant lecturer, Fixed Prosthodontics Department, Faculty of Oral and Dental Medicine, MTI University, Egypt.
4.Ahmed Gamal(A.G): Base line data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants' consents; Resident Fixed Prosthodontics Department, Faculty of Oral and Dental Medicine, MTI University, Egypt.
5.Eman Desouky (E.D.):Sample size calculation; Statistician, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Evidence Based Dentistry Committee (CEBD) Help in reporting study protocol following SPIRIT guidelines; Faculty of Oral and Dental Medicine, Cairo University, Egypt.
7.Research Ethics Committee (CREC): Protocol reviewer of the clinical trial in order to protect the right, safety, dignity and well-being of the participants; Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Research Plan Committee (CRPC):For ensuring that this clinical trial following the department research plan; Fixed prosthodontic Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Intervention: N.H. will perform conservative tooth preparation following the principles of all ceramic crown preparation with shoulder subgingival finish line of thickness 1.2mm using tapered stone with flat end attached to high speed headpiece with air and water coolant, after local anesthesia has been given. N.H. will take adequate 2ry Impression using non aqueous Elastomeric impression materials Impregum™F (medium consistency, 3M ESPE ,) and bite registration will by pink soft wax (Stardentalsupply) . N.A. \& E.O. will visually select the shade match using Vita Easyshade Compact (Vita Zahnfabrik, Bad Sa¨ckingen,Germany). N.H will fabricate the temporary restoration using Protemp™ 4 Temporisation Material(3M ESPE ) and cemented using non Eugenol Zinc Oxide temporary cement TempBond™ Temporization (Kerrdentalsupply). N.H will deliver Press Bio - HPP framework material veneered with visio lign veneering material (Bredent) crown and cement it with 3M™ ESPE™ RelyX™ Unicem Self-Adhesive Universal Resin Cement.
- Comparator N.H. will perform conservative tooth preparation following the principles of all ceramic crown preparation with shoulder subgingival finish line of thickness 1.2mm using tapered stone with flat end attached to high speed headpiece with air and water coolant, after local anesthesia has been given. N.H. will take adequate 2ry Impression using non aqueous Elastomeric impression materials Impregum™F (medium consistency, 3M ESPE ,) and bite registration will by pink soft wax (Stardentalsupply) . N.A. \& E.O. will visually select the shade match using Vita Easyshade Compact (Vita Zahnfabrik, Bad Sa¨ckingen,Germany). N.H will fabricate the temporary restoration using Protemp™ 4 Temporisation Material(3M ESPE ) and cemented using non Eugenol Zinc Oxide temporary cement TempBond™ Temporization (Kerrdentalsupply). N.H will deliver E.max® framework veneered with E-max veneering System (Ivoclar Vivadent) crown and cement it with 3M™ ESPE™ RelyX™ Unicem Self-Adhesive Universal Resin Cement.
- Outcomes
- Primary outcome: Patient satisfaction:
E.O will measure patient satisfaction using Rating scores. The mean and standard deviation for the Rating scores of the patients will be recorded at the time of crown cementation, 3, 6, 9 \& 12 months after review for aesthetics.
- Secondary outcome: Clinical assessment of the restoration:
E.O will evaluate shade matching, marginal discoloration and surface texture using modified USPHS criteria scores. The mean and standard deviation for the USPHS criteria scores of the patients will be recorded at the time of crown cementation 0, 3, 6, 9 \& 12 months after review for aesthetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Active comparator | Other: AllceramE-max is un allceram crown |
| Group 1 | Experimental | Other: hybrid crownBio HPP crown is a hybrid crown |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient will be able to physically and psychologically to tolerate conventional restorative procedures.
- Patients have no active periodontal or pulpal diseases, have teeth with good restorations.
- Patient with anterior tooth with 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 are willing to return for follow-up examination and evaluation.
- Patient with sound contralateral tooth to the selected tooth required for full coverage.
- Patient with root canal treated tooth requiring full coverage restoration
Key exclusion criteria (9 listed)
- Patient in the growth stage with partially erupted teeth.
- Patient with poor oral hygiene and motivation.
- Pregnant women's.
- Patient with psychiatric problems or unrealistic expectations.
- Patients have no opposing 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 |
|---|---|---|
| AllceramAlso: Prosthetic CrownPressed E-max coping veneered with E-max veneering system | Other | Group 2 |
| hybrid crownAlso: Prosthetic Crownpressed Bio HPP coping veneered with visolign veneering system | Other | Group 1 |
Primary outcome
Change in esthetic patient satisfaction
Time frame: At crown delivery time and after delivery 3, 6, 9, 12 month
using Rating scores from 0-2 (0= Poor, 1=Accepted, 2=Excellent)
3 secondary outcomes
Shade match to contralateral tooth
Time frame: At crown delivery time and after delivery 3, 6, 9, 12 month
Marginal discolouration
Time frame: At crown delivery time and after delivery 3, 6, 9, 12 month
Surface texture
Time frame: At crown delivery time and after delivery 3, 6, 9, 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allceram and hybrid 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 5 inclusion and 9 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 11 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in esthetic patient satisfaction (time frame: At crown delivery time and after delivery 3, 6, 9, 12 month). 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 11 Oct 2016.