Enamel and Ceramics WearNCT03530020
Wear Characteristics and Clinical Performance of Lithium Silicate Versus Monolithic Zirconia Crowns.
A study testing monolithic zirconia crowns and lithium silicate crowns in people with Enamel and Ceramics Wear, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the present study is to evaluate the wear characteristics and clinical performance of lithium silicate crowns in comparison to monolithic zirconia crowns. The quality of the overall restorations as well as gingival tissues will be also evaluated according to modified United States Public Health Service… Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Enamel and Ceramics Wear
- What is being tested?
- monolithic zirconia crowns and lithium silicate crowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 Feb 2020
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All subjects are required to be:
- Age range of the patients from 21-50 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. moderate to severe discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
- Patients with root canal treated teeth requiring full coverage restorations.
Show all 9Show fewer
- Presence of an opposing natural tooth which is non-restored or minimally restored. (Minimally restored is defined as teeth which have no restoration greater than a Class II a restoration)
- The opposing arch doesn't have a full coverage restoration or a partial denture.
- Patients willing to return for follow-up examinations and evaluation.
Who cannot join
- <!-- -->
- Patients with poor oral hygiene.
- 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 Para functional habits or temporomandibular disorders. (as those patient may have wear which will affect the results)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo university
Giza, 12613
Rasmia M salem, msc, 01024340442, rasmia.salem@yahoo.com
Gihan El Nagar, professor, drgigielnagar@yahoo.com
About this study
Official title: Wear Characteristics and Clinical Performance of Lithium Silicate Versus Monolithic Zirconia Crowns. (Randomized Controlled Clinical Trial)
The aim of the present study is to evaluate the wear characteristics and clinical performance of lithium silicate crowns in comparison to monolithic zirconia crowns.
The quality of the overall restorations as well as gingival tissues will be also evaluated according to modified United States Public Health Service (USPHS) criteria: (Marginal adaptation, color match, anatomic form, integrity of restoration, secondary caries, retention, tooth sensitivity, gingival index and periodontal index) at baseline, 6 months and 1 year
Read the detailed description
Recently advances in ceramics have greatly improved the mechanical and optical properties of restorative materials to overcome the drawbacks of all ceramic restorations over decades such as fracture, chipping, crack, wear and delamination of veneer ceramics.
Up to date despite the popularity of all ceramic restoration, the clinicians have been worried about the wear of tooth enamel antagonist to ceramic materials.
The wear properties of the ceramic restoration can affect the rate of wear of the antagonist enamel. So the wear resistance of ceramic restoration must be the same as enamel.
Explanation for choice of the comparator:
Monolithic zirconia attracts many dentists worldwide due to its excellent mechanical properties, biocompatibility and appreciate aesthetics. Some in vivo studies demonstrated the clinical success of monolithic zirconia restorations as an antagonist to natural enamel with good marginal adaptation, accepted contour, occlusion and minimum gingival response.
Batson et al. studied the quality of CAD/CAM fabricated single tooth restorations (Ten zirconia restorations were compared to 12 metal ceramic and 10 lithium disilicate counterparts) .They found that were no significant differences between the studied crown systems. No difference of the gingival response among the different crown systems. Eighty percent of zirconia crowns needed no occlusal adjustment; also it showed the least amount of marginal discrepancy.
Lohbauer et al. evaluated the amount of wear on the antagonist occlusal surfaces of clinically placed monolithic zirconia premolar and molar crowns using optical profilometry after 2 years of cementation, they found that the mean volume loss for enamel antagonist contacts (n = 7) was measured to 361 μm and the mean of the maximum vertical loss to 204 μm. The mean volume loss for pure ceramic contacts (n = 10) was measured to 333 μm and the mean of the maximum vertical loss to 145 μm.
Mundhe et al.compared the wear of enamel opposing polished zirconia, glazed metal ceramic crowns and natural enamel as a control, one year after the cementation. They found that the occlusal wear of the antagonistic enamel one year after the cementation of metal ceramic crowns ranged from 69.20 ± 4.10 to 179.70 ± 8.09 μm, whereas, for zirconia crowns, it was from 42.10 ± 4.30 to 127.00 ± 5.03 μm.
Stober et al. reported that after 2 years of cementation of the monolithic zirconia crowns, Mean and maximum vertical loss of enamel in occlusal contact areas caused by monolithic zirconia (46 and 151 μm, respectively) was approximately double that caused by contralateral antagonistic enamel (19-26 and 75-115 μm, respectively).
A lithium silicate glass ceramic (obsidian ceramic) is newly introduced to the market. After crystallization, it exhibits an ideal combination of esthetics and strength with translucency that mirrors the vitality of natural teeth for fabrication of full anatomic anterior and posterior crowns. Obsidian ceramic restorations are highly resistant to chipping unlike other ceramics, due to their monolithic composition and average flexural strength of 385 MPa. Also Obsidian Milling Block owes its good wear resistance due to a very high content of ultrafine nanometer-size crystalline structure.
- Conditions
- Enamel and Ceramics Wear
- Being tested
- monolithic zirconia crowns, lithium silicate crowns
- Keywords
- monolithic zirconia, tooth wear, all ceramic crown
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monolithic zirconia crownsOther
Also called katana zirconia, Kuraray Noritake , Japan
full anatomical monolithic crowns
lithium silicate crownsOther
Also called obsidian, Glide well Laboratories, USA
lithium silicate glass ceramics are highly resistance to chipping
| Study group | Role | What they receive |
|---|---|---|
| monolithic zirconia crowns | Active comparator | Monolithic zirconia attracts many dentists worldwide due to its excellent mechanical properties, biocompatibility and appreciate aesthetics Receives: Other: monolithic zirconia crowns |
| lithium silicate crowns | Experimental | A lithium silicate glass ceramic is newly introduced to the market. After crystallization, it exhibits an ideal combination of aesthetics and strength with translucency that mirrors the vitality of natural teeth for fabrication of full anatomic anterior and posterior crowns. Receives: Other: lithium silicate crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wear of all ceramic crowns and color matching
(Wear of ceramic crowns) of the two groups will be assessed using the 3D optical profilometer.
Measured: 12 month
color matching
Color match of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:
- Alpha (Excellent) ideal.
- Bravo (Acceptable) less than ideal but no modifications required
- Charlie (Acceptable but modifications needed) staining or other shade modifications required.
- Delta (Unacceptable) remake.
Measured: 12 month
Secondary outcomes (9)
Wear of enamel antagonist to all ceramic crowns
wear of antagonist enamel of the two groups will be assessed using the 3D optical profilometer.
Measured: 12 month
Marginal adaptation
of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:
- Alpha (Excellent) ideal.
- Bravo (Acceptable) less than ideal but no modifications required
- Charlie (Acceptable but modifications needed) modifications required.
- Delta (Unacceptable) remake.
Measured: 12 month
anatomic form
of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:
- Alpha (Excellent) ideal.
- Bravo (Acceptable) less than ideal but no modifications required
- Charlie (Acceptable but modifications needed) modifications required.
- Delta (Unacceptable) remake.
Measured: 12 month
integrity of restoration
of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:
- Alpha (Excellent) ideal.
- Bravo (Acceptable) less than ideal but no modifications required
- Charlie (Acceptable but modifications needed) modifications required.
- Delta (Unacceptable) remake.
Measured: 12 month
secondary caries
of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:
- Alpha (Excellent) ideal.
- Bravo (Acceptable) less than ideal but no modifications required
- Charlie (Acceptable but modifications needed) modifications required.
- Delta (Unacceptable) remake.
Measured: 12 month
retention
of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:
- Alpha (Excellent) ideal.
- Bravo (Acceptable) less than ideal but no modifications required
- Charlie (Acceptable but modifications needed) modifications required.
- Delta (Unacceptable) remake.
Measured: 12 month
opposing tooth sensitivity
of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:
- Alpha (Excellent) ideal.
- Bravo (Acceptable) less than ideal but no modifications required
- Charlie (Acceptable but modifications needed) modifications required.
- Delta (Unacceptable) remake.
Measured: 12 month
gingival condition
Gingival index by Visual inspection using Score from 0-3
Measured: 12 month
periodontal condition
Periodontal index by Periodontal probe using Score from 0-4
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Feb 2019 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Enamel and Ceramics WearStudies 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
- Model description
- Patient will receive a restoration with superior function, esthetics, and excellent clinical performance.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmia Mamdouh Ali Salem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530020
- Sponsor's protocol ID
- enamel and ceramics wear
- Status last verified
- Jan 2019
- First submitted
- 7 May 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Larsson C, Wennerberg A. The clinical success of zirconia-based crowns: a systematic review. Int J Prosthodont. 2014 Jan-Feb;27(1):33-43. doi: 10.11607/ijp.3647.
PubMed 24392475Daou EE. Esthetic Prosthetic Restorations: Reliability and Effects on Antagonist Dentition. Open Dent J. 2015 Dec 31;9:473-81. doi: 10.2174/1874210601509010473. eCollection 2015.
PubMed 26962376Mehta SB, Banerji S, Millar BJ, Suarez-Feito JM. Current concepts on the management of tooth wear: part 1. Assessment, treatment planning and strategies for the prevention and the passive management of tooth wear. Br Dent J. 2012 Jan 13;212(1):17-27. doi: 10.1038/sj.bdj.2011.1099.
PubMed 22240686Mundhe K, Jain V, Pruthi G, Shah N. Clinical study to evaluate the wear of natural enamel antagonist to zirconia and metal ceramic crowns. J Prosthet Dent. 2015 Sep;114(3):358-63. doi: 10.1016/j.prosdent.2015.03.001. Epub 2015 May 16.
PubMed 25985742Olivera AB, Marques MM. Esthetic restorative materials and opposing enamel wear. Oper Dent. 2008 May-Jun;33(3):332-7. doi: 10.2341/07-95.
PubMed 18505225Magne P, Oh WS, Pintado MR, DeLong R. Wear of enamel and veneering ceramics after laboratory and chairside finishing procedures. J Prosthet Dent. 1999 Dec;82(6):669-79. doi: 10.1016/s0022-3913(99)70008-9.
PubMed 10588803Burgess JO, Janyavula S, Lawson NC, Lucas TJ, Cakir D. Enamel wear opposing polished and aged zirconia. Oper Dent. 2014 Mar-Apr;39(2):189-94. doi: 10.2341/12-345-L. Epub 2013 Jul 12.
PubMed 23848069Preis V, Weiser F, Handel G, Rosentritt M. Wear performance of monolithic dental ceramics with different surface treatments. Quintessence Int. 2013 May;44(5):393-405. doi: 10.3290/j.qi.a29151.
PubMed 23479579Park JH, Park S, Lee K, Yun KD, Lim HP. Antagonist wear of three CAD/CAM anatomic contour zirconia ceramics. J Prosthet Dent. 2014 Jan;111(1):20-9. doi: 10.1016/j.prosdent.2013.06.002. Epub 2013 Nov 5.
PubMed 24199603Janyavula S, Lawson N, Cakir D, Beck P, Ramp LC, Burgess JO. The wear of polished and glazed zirconia against enamel. J Prosthet Dent. 2013 Jan;109(1):22-9. doi: 10.1016/S0022-3913(13)60005-0.
PubMed 23328193Stober T, Bermejo JL, Rammelsberg P, Schmitter M. Enamel wear caused by monolithic zirconia crowns after 6 months of clinical use. J Oral Rehabil. 2014 Apr;41(4):314-22. doi: 10.1111/joor.12139. Epub 2014 Jan 22.
PubMed 24447258Lawson NC, Janyavula S, Syklawer S, McLaren EA, Burgess JO. Wear of enamel opposing zirconia and lithium disilicate after adjustment, polishing and glazing. J Dent. 2014 Dec;42(12):1586-91. doi: 10.1016/j.jdent.2014.09.008. Epub 2014 Sep 23.
PubMed 25257823Samer MS, Faraz Q, Al-Dubai SAR, Vohra F, Abdullah H, Taiyeb-Ali TB, Saub R. Clinical Outcomes and Predictors of Satisfaction in Patients with Improved Lithium Disilicate All-Ceramic Crowns. Med Princ Pract. 2017;26(5):470-479. doi: 10.1159/000481864. Epub 2017 Oct 1.
PubMed 28965115Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.
PubMed 16315023Lohbauer U, Reich S. Antagonist wear of monolithic zirconia crowns after 2 years. Clin Oral Investig. 2017 May;21(4):1165-1172. doi: 10.1007/s00784-016-1872-6. Epub 2016 Jun 9.
PubMed 27277661
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wear Characteristics and Clinical Performance of Lithium Silicate Versus Monolithic Zirconia Crowns. (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT03530020
- Acronym / sponsor ID
- enamel and ceramics wear
- Conditions
- Enamel and Ceramics Wear
- Keywords
- monolithic zirconia, tooth wear, all ceramic crown
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 21 May 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.
The aim of the present study is to evaluate the wear characteristics and clinical performance of lithium silicate crowns in comparison to monolithic zirconia crowns.
The quality of the overall restorations as well as gingival tissues will be also evaluated according to modified United States Public Health Service (USPHS) criteria: (Marginal adaptation, color match, anatomic form, integrity of restoration, secondary caries, retention, tooth sensitivity, gingival index and periodontal index) at baseline, 6 months and 1 year
Detailed description
Recently advances in ceramics have greatly improved the mechanical and optical properties of restorative materials to overcome the drawbacks of all ceramic restorations over decades such as fracture, chipping, crack, wear and delamination of veneer ceramics.
Up to date despite the popularity of all ceramic restoration, the clinicians have been worried about the wear of tooth enamel antagonist to ceramic materials.
The wear properties of the ceramic restoration can affect the rate of wear of the antagonist enamel. So the wear resistance of ceramic restoration must be the same as enamel.
Explanation for choice of the comparator:
Monolithic zirconia attracts many dentists worldwide due to its excellent mechanical properties, biocompatibility and appreciate aesthetics. Some in vivo studies demonstrated the clinical success of monolithic zirconia restorations as an antagonist to natural enamel with good marginal adaptation, accepted contour, occlusion and minimum gingival response.
Batson et al. studied the quality of CAD/CAM fabricated single tooth restorations (Ten zirconia restorations were compared to 12 metal ceramic and 10 lithium disilicate counterparts) .They found that were no significant differences between the studied crown systems. No difference of the gingival response among the different crown systems. Eighty percent of zirconia crowns needed no occlusal adjustment; also it showed the least amount of marginal discrepancy.
Lohbauer et al. evaluated the amount of wear on the antagonist occlusal surfaces of clinically placed monolithic zirconia premolar and molar crowns using optical profilometry after 2 years of cementation, they found that the mean volume loss for enamel antagonist contacts (n = 7) was measured to 361 μm and the mean of the maximum vertical loss to 204 μm. The mean volume loss for pure ceramic contacts (n = 10) was measured to 333 μm and the mean of the maximum vertical loss to 145 μm.
Mundhe et al.compared the wear of enamel opposing polished zirconia, glazed metal ceramic crowns and natural enamel as a control, one year after the cementation. They found that the occlusal wear of the antagonistic enamel one year after the cementation of metal ceramic crowns ranged from 69.20 ± 4.10 to 179.70 ± 8.09 μm, whereas, for zirconia crowns, it was from 42.10 ± 4.30 to 127.00 ± 5.03 μm.
Stober et al. reported that after 2 years of cementation of the monolithic zirconia crowns, Mean and maximum vertical loss of enamel in occlusal contact areas caused by monolithic zirconia (46 and 151 μm, respectively) was approximately double that caused by contralateral antagonistic enamel (19-26 and 75-115 μm, respectively).
A lithium silicate glass ceramic (obsidian ceramic) is newly introduced to the market. After crystallization, it exhibits an ideal combination of esthetics and strength with translucency that mirrors the vitality of natural teeth for fabrication of full anatomic anterior and posterior crowns. Obsidian ceramic restorations are highly resistant to chipping unlike other ceramics, due to their monolithic composition and average flexural strength of 385 MPa. Also Obsidian Milling Block owes its good wear resistance due to a very high content of ultrafine nanometer-size crystalline structure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patient will receive a restoration with superior function, esthetics, and excellent clinical performance.
| Arm | Type | Receives |
|---|---|---|
| monolithic zirconia crowns | Active comparator | Other: monolithic zirconia crownsMonolithic zirconia attracts many dentists worldwide due to its excellent mechanical properties, biocompatibility and appreciate aesthetics |
| lithium silicate crowns | Experimental | Other: lithium silicate crownsA lithium silicate glass ceramic is newly introduced to the market. After crystallization, it exhibits an ideal combination of aesthetics and strength with translucency that mirrors the vitality of natural teeth for fabrication of full anatomic anterior and posterior crowns. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- All subjects are required to be:
Key exclusion criteria (5 listed)
- <!-- -->
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 |
|---|---|---|
| monolithic zirconia crownsAlso: katana zirconia, Kuraray Noritake , Japanfull anatomical monolithic crowns | Other | monolithic zirconia crowns |
| lithium silicate crownsAlso: obsidian, Glide well Laboratories, USAlithium silicate glass ceramics are highly resistance to chipping | Other | lithium silicate crowns |
Primary outcome
Wear of all ceramic crowns and color matching
Time frame: 12 month
(Wear of ceramic crowns) of the two groups will be assessed using the 3D optical profilometer.
color matching
Time frame: 12 month
Color match of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows: * Alpha (Excellent) ideal. * Bravo (Acceptable) less than ideal but no modifications required * Charlie (Acceptable but modifications needed) staining or other shade modifications required. * Delta (Unacceptable) remake.
9 secondary outcomes
Wear of enamel antagonist to all ceramic crowns
Time frame: 12 month
Marginal adaptation
Time frame: 12 month
anatomic form
Time frame: 12 month
integrity of restoration
Time frame: 12 month
secondary caries
Time frame: 12 month
retention
Time frame: 12 month
opposing tooth sensitivity
Time frame: 12 month
gingival condition
Time frame: 12 month
periodontal condition
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Background: PubMed 24392475Larsson C, Wennerberg A. The clinical success of zirconia-based crowns: a systematic review. Int J Prosthodont. 2014 Jan-Feb;27(1):33-43. doi: 10.11607/ijp.3647.
- Background: PubMed 26962376Daou EE. Esthetic Prosthetic Restorations: Reliability and Effects on Antagonist Dentition. Open Dent J. 2015 Dec 31;9:473-81. doi: 10.2174/1874210601509010473. eCollection 2015.
- Background: PubMed 22240686Mehta SB, Banerji S, Millar BJ, Suarez-Feito JM. Current concepts on the management of tooth wear: part 1. Assessment, treatment planning and strategies for the prevention and the passive management of tooth wear. Br Dent J. 2012 Jan 13;212(1):17-27. doi: 10.1038/sj.bdj.2011.1099.
- Background: PubMed 25985742Mundhe K, Jain V, Pruthi G, Shah N. Clinical study to evaluate the wear of natural enamel antagonist to zirconia and metal ceramic crowns. J Prosthet Dent. 2015 Sep;114(3):358-63. doi: 10.1016/j.prosdent.2015.03.001. Epub 2015 May 16.
- Background: PubMed 18505225Olivera AB, Marques MM. Esthetic restorative materials and opposing enamel wear. Oper Dent. 2008 May-Jun;33(3):332-7. doi: 10.2341/07-95.
- Background: PubMed 10588803Magne P, Oh WS, Pintado MR, DeLong R. Wear of enamel and veneering ceramics after laboratory and chairside finishing procedures. J Prosthet Dent. 1999 Dec;82(6):669-79. doi: 10.1016/s0022-3913(99)70008-9.
- Background: PubMed 23848069Burgess JO, Janyavula S, Lawson NC, Lucas TJ, Cakir D. Enamel wear opposing polished and aged zirconia. Oper Dent. 2014 Mar-Apr;39(2):189-94. doi: 10.2341/12-345-L. Epub 2013 Jul 12.
- Background: PubMed 23479579Preis V, Weiser F, Handel G, Rosentritt M. Wear performance of monolithic dental ceramics with different surface treatments. Quintessence Int. 2013 May;44(5):393-405. doi: 10.3290/j.qi.a29151.
- Background: PubMed 24199603Park JH, Park S, Lee K, Yun KD, Lim HP. Antagonist wear of three CAD/CAM anatomic contour zirconia ceramics. J Prosthet Dent. 2014 Jan;111(1):20-9. doi: 10.1016/j.prosdent.2013.06.002. Epub 2013 Nov 5.
- Background: PubMed 23328193Janyavula S, Lawson N, Cakir D, Beck P, Ramp LC, Burgess JO. The wear of polished and glazed zirconia against enamel. J Prosthet Dent. 2013 Jan;109(1):22-9. doi: 10.1016/S0022-3913(13)60005-0.
- Background: PubMed 24447258Stober T, Bermejo JL, Rammelsberg P, Schmitter M. Enamel wear caused by monolithic zirconia crowns after 6 months of clinical use. J Oral Rehabil. 2014 Apr;41(4):314-22. doi: 10.1111/joor.12139. Epub 2014 Jan 22.
- Background: PubMed 25257823Lawson NC, Janyavula S, Syklawer S, McLaren EA, Burgess JO. Wear of enamel opposing zirconia and lithium disilicate after adjustment, polishing and glazing. J Dent. 2014 Dec;42(12):1586-91. doi: 10.1016/j.jdent.2014.09.008. Epub 2014 Sep 23.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monolithic zirconia crowns and lithium silicate crowns in people with Enamel and Ceramics Wear, 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 9 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 3 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rasmia salem, msc (01024340442, rasmia.salem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wear of all ceramic crowns and color matching (time frame: 12 month). The study lists 2 primary outcomes in all. 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 NCT03530020, which also lists 19 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 3 Jan 2019.