Personal SatisfactionNCT04757428
Clinical Evaluation of Lithium Disilicate and Hybrid Nano-ceramic Anterior Endocrowns (Randomized Clinical Trial)
A study testing Endocrown in people with Personal Satisfaction, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study was to evaluate the clinical performance of two CAD/CAM materials, hybrid nano-ceramic and lithium disilicate ceramic, in the fabrication of anterior endocrowns in patients with anterior endodontically treated teeth. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Personal Satisfaction
- What is being tested?
- Endocrown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Aug 2022to 11 Aug 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with good oral hygiene
- Patients having one or more endodontically treated molars that need prosthetic restoration.
- Molars should have enough tooth structure for endocrown restoration with minimum 3 walls with thickness not less than 1.5 mm and gingival step placed supragingival
- Fully erupted molars
- Molars free of developmental defect
- Healthy periodontium
- Absence of periapical pathosis
- Acceptable endodontic treatment and proper bone support
Who cannot join
- Patients with bad oral hygiene
- Patients with active periodontal disease
- Patients with missing teeth opposing to the area intended for restoration
- Patients with parafunctional habits or psychiatric problems or unrealistic expectation.
Trial locations and contacts
1 site in 1 country.
About this study
the aim of this study was to evaluate the clinical performance of two CAD/CAM materials, hybrid nano-ceramic and lithium disilicate ceramic, in the fabrication of anterior endocrowns in patients with anterior endodontically treated teeth. While the postulated null hypothesis of this study was that there will be no significant difference between the performance of hybrid nanoceramic and lithium disilicate anterior endocrowns in patients with endodontically treated teeth.
- Conditions
- Personal Satisfaction
- Being tested
- Endocrown
- Keywords
- Lithium disilicate, hybrid ceramic
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndocrownProcedure or surgery
Endocrown
| Study group | Role | What they receive |
|---|---|---|
| Lithium disilicate | Active comparator | The intervention will be: Prosthetic endocrown Receives: Procedure: Endocrown |
| Hybrid nanoceramic | Active comparator | The intervention will be: Prosthetic endocrown Receives: Procedure: Endocrown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Using Binary Visual Analogue scale (Satisfied/ not satisfied)
Measured: 2 years
Secondary outcomes (1)
Shade matching
Using the modified United States Public Health Service criteria (Modified USPHS)- categorical
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start11 Aug 2022
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abou-steit, Cairo University
- Investigators
- Sameh Sh Abou-steit, PhD, Principal investigator, Lecturer of Fixed Prosthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757428
- Sponsor's protocol ID
- CEBD 37/7/22
- Status last verified
- Jul 2024
- First submitted
- 31 Jan 2021
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
da Cunha LF, Gonzaga CC, Pissaia JF, Correr GM. Lithium silicate endocrown fabricated with a CAD-CAM system: A functional and esthetic protocol. J Prosthet Dent. 2017 Aug;118(2):131-134. doi: 10.1016/j.prosdent.2016.10.006. Epub 2017 Jan 13.
PubMed 28089332Wang F, Yu T, Chen J. Biaxial flexural strength and translucent characteristics of dental lithium disilicate glass ceramics with different translucencies. J Prosthodont Res. 2020 Jan;64(1):71-77. doi: 10.1016/j.jpor.2019.04.007. Epub 2019 May 11.
PubMed 31088735Rosentritt M, Preis V, Behr M, Hahnel S. Influence of preparation, fitting, and cementation on the vitro performance and fracture resistance of CAD/CAM crowns. J Dent. 2017 Oct;65:70-75. doi: 10.1016/j.jdent.2017.07.006. Epub 2017 Jul 19.
PubMed 28734997Tribst JPM, Dal Piva AMO, Madruga CFL, Valera MC, Borges ALS, Bresciani E, de Melo RM. Endocrown restorations: Influence of dental remnant and restorative material on stress distribution. Dent Mater. 2018 Oct;34(10):1466-1473. doi: 10.1016/j.dental.2018.06.012. Epub 2018 Jun 21.
PubMed 29935769da Fonseca GF, Dal Piva AM, Tribst JP, Borges AL. Influence of Restoration Height and Masticatory Load Orientation on Ceramic Endocrowns. J Contemp Dent Pract. 2018 Sep 1;19(9):1052-1057.
PubMed 30287703Schaefer O, Watts DC, Sigusch BW, Kuepper H, Guentsch A. Marginal and internal fit of pressed lithium disilicate partial crowns in vitro: a three-dimensional analysis of accuracy and reproducibility. Dent Mater. 2012 Mar;28(3):320-6. doi: 10.1016/j.dental.2011.12.008. Epub 2012 Jan 21.
PubMed 22265824Shamseddine L, Mortada R, Rifai K, Chidiac JJ. Marginal and internal fit of pressed ceramic crowns made from conventional and computer-aided design and computer-aided manufacturing wax patterns: An in vitro comparison. J Prosthet Dent. 2016 Aug;116(2):242-8. doi: 10.1016/j.prosdent.2015.12.005. Epub 2016 Mar 3.
PubMed 26948080Belleflamme MM, Geerts SO, Louwette MM, Grenade CF, Vanheusden AJ, Mainjot AK. No post-no core approach to restore severely damaged posterior teeth: An up to 10-year retrospective study of documented endocrown cases. J Dent. 2017 Aug;63:1-7. doi: 10.1016/j.jdent.2017.04.009. Epub 2017 Apr 27.
PubMed 28456557Tzimas K, Tsiafitsa M, Gerasimou P, Tsitrou E. Endocrown restorations for extensively damaged posterior teeth: clinical performance of three cases. Restor Dent Endod. 2018 Aug 22;43(4):e38. doi: 10.5395/rde.2018.43.e38. eCollection 2018 Nov.
PubMed 30483462Sedrez-Porto JA, Rosa WL, da Silva AF, Munchow EA, Pereira-Cenci T. Endocrown restorations: A systematic review and meta-analysis. J Dent. 2016 Sep;52:8-14. doi: 10.1016/j.jdent.2016.07.005. Epub 2016 Jul 12.
PubMed 27421989Furtado de Mendonca A, Shahmoradi M, Gouvea CVD, De Souza GM, Ellakwa A. Microstructural and Mechanical Characterization of CAD/CAM Materials for Monolithic Dental Restorations. J Prosthodont. 2019 Feb;28(2):e587-e594. doi: 10.1111/jopr.12964. Epub 2018 Aug 18.
PubMed 30121945Otto T, Mormann WH. Clinical performance of chairside CAD/CAM feldspathic ceramic posterior shoulder crowns and endocrowns up to 12 years. Int J Comput Dent. 2015;18(2):147-61. English, German.
PubMed 26110927
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Lithium Disilicate and Hybrid Nano-ceramic Anterior Endocrowns (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04757428
- Acronym / sponsor ID
- CEBD 37/7/22
- Conditions
- Personal Satisfaction
- Keywords
- Lithium disilicate, hybrid ceramic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 17 Feb 2021 (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.
the aim of this study was to evaluate the clinical performance of two CAD/CAM materials, hybrid nano-ceramic and lithium disilicate ceramic, in the fabrication of anterior endocrowns in patients with anterior endodontically treated teeth. While the postulated null hypothesis of this study was that there will be no significant difference between the performance of hybrid nanoceramic and lithium disilicate anterior endocrowns in patients with endodontically treated teeth.
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 | Procedure: EndocrownThe intervention will be: Prosthetic endocrown |
| Hybrid nanoceramic | Active comparator | Procedure: EndocrownThe intervention will be: Prosthetic endocrown |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with good oral hygiene
- Patients having one or more endodontically treated molars that need prosthetic restoration.
- Molars should have enough tooth structure for endocrown restoration with minimum 3 walls with thickness not less than 1.5 mm and gingival step placed supragingival
- Fully erupted molars
- Molars free of developmental defect
Key exclusion criteria (4 listed)
- Patients with bad oral hygiene
- Patients with active periodontal disease
- Patients with missing teeth opposing to the area intended for restoration
- Patients with parafunctional habits or psychiatric problems or unrealistic expectation.
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 |
|---|---|---|
| EndocrownEndocrown | Procedure or surgery | Hybrid nanoceramic, Lithium disilicate |
Primary outcome
Patient satisfaction
Time frame: 2 years
Using Binary Visual Analogue scale (Satisfied/ not satisfied)
1 secondary outcome
Shade matching
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Background: PubMed 28089332da Cunha LF, Gonzaga CC, Pissaia JF, Correr GM. Lithium silicate endocrown fabricated with a CAD-CAM system: A functional and esthetic protocol. J Prosthet Dent. 2017 Aug;118(2):131-134. doi: 10.1016/j.prosdent.2016.10.006. Epub 2017 Jan 13.
- Background: PubMed 31088735Wang F, Yu T, Chen J. Biaxial flexural strength and translucent characteristics of dental lithium disilicate glass ceramics with different translucencies. J Prosthodont Res. 2020 Jan;64(1):71-77. doi: 10.1016/j.jpor.2019.04.007. Epub 2019 May 11.
- Background: PubMed 28734997Rosentritt M, Preis V, Behr M, Hahnel S. Influence of preparation, fitting, and cementation on the vitro performance and fracture resistance of CAD/CAM crowns. J Dent. 2017 Oct;65:70-75. doi: 10.1016/j.jdent.2017.07.006. Epub 2017 Jul 19.
- Background: PubMed 29935769Tribst JPM, Dal Piva AMO, Madruga CFL, Valera MC, Borges ALS, Bresciani E, de Melo RM. Endocrown restorations: Influence of dental remnant and restorative material on stress distribution. Dent Mater. 2018 Oct;34(10):1466-1473. doi: 10.1016/j.dental.2018.06.012. Epub 2018 Jun 21.
- Background: PubMed 30287703da Fonseca GF, Dal Piva AM, Tribst JP, Borges AL. Influence of Restoration Height and Masticatory Load Orientation on Ceramic Endocrowns. J Contemp Dent Pract. 2018 Sep 1;19(9):1052-1057.
- Background: PubMed 22265824Schaefer O, Watts DC, Sigusch BW, Kuepper H, Guentsch A. Marginal and internal fit of pressed lithium disilicate partial crowns in vitro: a three-dimensional analysis of accuracy and reproducibility. Dent Mater. 2012 Mar;28(3):320-6. doi: 10.1016/j.dental.2011.12.008. Epub 2012 Jan 21.
- Background: PubMed 26948080Shamseddine L, Mortada R, Rifai K, Chidiac JJ. Marginal and internal fit of pressed ceramic crowns made from conventional and computer-aided design and computer-aided manufacturing wax patterns: An in vitro comparison. J Prosthet Dent. 2016 Aug;116(2):242-8. doi: 10.1016/j.prosdent.2015.12.005. Epub 2016 Mar 3.
- Background: PubMed 28456557Belleflamme MM, Geerts SO, Louwette MM, Grenade CF, Vanheusden AJ, Mainjot AK. No post-no core approach to restore severely damaged posterior teeth: An up to 10-year retrospective study of documented endocrown cases. J Dent. 2017 Aug;63:1-7. doi: 10.1016/j.jdent.2017.04.009. Epub 2017 Apr 27.
- Background: PubMed 30483462Tzimas K, Tsiafitsa M, Gerasimou P, Tsitrou E. Endocrown restorations for extensively damaged posterior teeth: clinical performance of three cases. Restor Dent Endod. 2018 Aug 22;43(4):e38. doi: 10.5395/rde.2018.43.e38. eCollection 2018 Nov.
- Background: PubMed 27421989Sedrez-Porto JA, Rosa WL, da Silva AF, Munchow EA, Pereira-Cenci T. Endocrown restorations: A systematic review and meta-analysis. J Dent. 2016 Sep;52:8-14. doi: 10.1016/j.jdent.2016.07.005. Epub 2016 Jul 12.
- Background: PubMed 30121945Furtado de Mendonca A, Shahmoradi M, Gouvea CVD, De Souza GM, Ellakwa A. Microstructural and Mechanical Characterization of CAD/CAM Materials for Monolithic Dental Restorations. J Prosthodont. 2019 Feb;28(2):e587-e594. doi: 10.1111/jopr.12964. Epub 2018 Aug 18.
- Background: PubMed 26110927Otto T, Mormann WH. Clinical performance of chairside CAD/CAM feldspathic ceramic posterior shoulder crowns and endocrowns up to 12 years. Int J Comput Dent. 2015;18(2):147-61. English, German.
- Individual participant dataSharing planned: Undecided
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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.
Sameh Sh Abou-steit, PhD principal investigator
Lecturer of Fixed Prosthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocrown in people with Personal Satisfaction, run by Cairo University at 1 site in Egypt.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient satisfaction (time frame: 2 years). 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 NCT04757428, which also lists 12 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 5 Jul 2024.