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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

rasmia salem, msc contact

01024340442

rasmia.salem@yahoo.com

Egypt1 site
  • Cairo university

    Giza, 12613

    Rasmia M salem, msc, 01024340442, rasmia.salem@yahoo.com

    Gihan El Nagar, professor, drgigielnagar@yahoo.com

Other trials in Egypt

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.

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 groups in NCT03530020
Study groupRoleWhat they receive
monolithic zirconia crownsActive comparatorMonolithic zirconia attracts many dentists worldwide due to its excellent mechanical properties, biocompatibility and appreciate aesthetics
Receives: Other: monolithic zirconia crowns
lithium silicate crownsExperimentalA 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. gingival condition

    Gingival index by Visual inspection using Score from 0-3

    Measured: 12 month

  9. 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.

  1. First posted21 May 2018
  2. Study start1 Feb 2019 (estimated)
  3. Primary completion1 Dec 2019 (estimated)
  4. Study completion1 Feb 2020 (estimated)

Resources

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)
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 24392475
  • Daou 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 26962376
  • Mehta 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 22240686
  • Mundhe 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 25985742
  • Olivera 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 18505225
  • Magne 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 10588803
  • Burgess 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 23848069
  • Preis 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 23479579
  • Park 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 24199603
  • Janyavula 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 23328193
  • Stober 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 24447258
  • Lawson 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 25257823
  • Samer 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 28965115
  • Cvar 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 16315023
  • Lohbauer 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

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.

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