AzTrials
AzTrials

Carious TeethNCT05281861

Marginal Evaluation of Zirconia Reinforced Lithium Disilicate Partial Coverage Restoration of Egyptian Posterior Teeth.

A study testing Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restoration and Lithium disilicate (IPS e-max press) ceramic onlay restoration in people with Carious Teeth and Adaptation, run by Al-Azhar University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Objective: To evaluate the marginal adaptation of the zirconia reinforced lithium disilicate (VITA AMBRIA) glass ceramic Inlay/Onlay compared with lithium disilicate(IPS emax Press) glass ceramic Inlay/Onlay in decayed posterior teeth. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Carious Teeth, Adaptation
What is being tested?
Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restoration and Lithium disilicate (IPS e-max press) ceramic onlay restoration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Apr 2022to 1 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • The patient is healthy.
  • 18-50 years old.
  • Normal occlusion.
  • Good oral hygiene.
  • Tooth with complete root apex.
  • Tooth with moderate coronal decay.

Who cannot join

  • Patient Incapable of self-care, mental illness, undergoing radiotherapy, diabetic patient, allergy to one of the materials used, pregnancy, smoker, parafunctional habits, poor oral hygiene, severe periodontitis, tooth need vital pulp therapy or surgical crown lengthening or marginal elevation, tooth with enamel or dentin hypoplasia or hypocalcification, Mallaligned or malformed teeth and adjacent or opposing teeth are missed.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Al-Azhar University (Cairo)

    Cairo

Other trials in Egypt

About this study

Official title: Evaluation of Marginal Adaptation of Onlay Restorations Constructed From Two Types of Glass Ceramics: A Randomized Clinical Trial

Objective: To evaluate the marginal adaptation of the zirconia reinforced lithium disilicate (VITA AMBRIA) glass ceramic Inlay/Onlay compared with lithium disilicate(IPS emax Press) glass ceramic Inlay/Onlay in decayed posterior teeth.

Read the detailed description

A randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by one trained and calibrated operators who perform all restorative procedures. The restorations will be evaluated by a blind and calibrated two examiner using the FDI (World Dental Federation) criteria. A total of 25 subject will be randomly assigned to each group for a total of 50 subject. The randomization sequence will be generated (www.randomlists.com/team-generator) and to ensure the confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in series. These will be kept with an independent researcher for the moment of inclusion of the subjects.

Both groups will receive Inlay/Onlay preparation . Digital impression will be taken, wax pattern for the Inlay/Onlay restoration will be designed and milled using CAD/CAM(computer-aided design/computer-aided manufacturing) software. After that, the wax pattern will be invested and final Inlay/Onlay restoration will be constructed from VITA AMBRIA and IPS e.max press ingots according to manufacturing instructions.

Being tested
Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restoration, Lithium disilicate (IPS e-max press) ceramic onlay restoration
Keywords
Inlay, Onlay, Partial coverage,
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restorationOther

    In experimental group, Participants will be restored with onlay ceramic restorations constructed from zirconia reinforced Lithium disilicate (Vita Ambria) glass ceramic

  • Lithium disilicate (IPS e-max press) ceramic onlay restorationOther

    In control group, Participants will be restored with onlay ceramic restorations constructed from Lithium disilicate (IPS e-max press) glass ceramic

Study groups in NCT05281861
Study groupRoleWhat they receive
Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restorationExperimentalThe onlays will be constructed from Zirconia reinforced Lithium disilicate (Vita Ambria) glass ceramic system
Receives: Other: Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restoration
Lithium disilicate (IPS e-max press) ceramic onlay restorationActive comparatorThe onlays will be constructed from Lithium disilicate (IPS e-max press) glass ceramic system
Receives: Other: Lithium disilicate (IPS e-max press) ceramic onlay restoration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Marginal Adaptation

    Measuring device: visual and probe.

    According to FDI standard(Grade 1-5), which has been defined as follows:

    Grade 1. Harmonious outline, no gaps, no white or discolored lines. Grade 2. Marginal gap (> 50 μm and < 150 μm), white lines; small marginal fracture removable by polishing; slight ditching, slight step /flashes, minor irregularities Grade 3. Gap (> 150 μm and < 250 μm) not removable; several small marginal fractures; major irregularities, ditching or flash, steps.

    Grade 4. Gap (> 250 μm) dentine/base exposed, chip fracture damaging margins, Notable enamel, or dentine wall fracture.

    Grade 5. Restoration is loose but in situ.

    Measured: 1 year follow up

Secondary outcomes (3)

  1. Restoration Fracture and retention

    Fracture and retention of the onlay restoration will be evaluated. Measuring device: visual and probe.

    According to FDI standard (Grade 1-5), which has been defined as follows:

    Grade 1: Restoration is present with no fractures, cracks or chipping. Grade 2:Small hairline cracks are visible. Grade 3:Several hairline cracks are present and/or limited chipping of material without damage to marginal quality or proximal contacts.

    Grade 4: Fractures affect marginal quality and/or proximal contacts; bulk fractures with probable gap > 250 μm with or without partial loss of less than half the restoration.

    Grade 5:Loss of restoration or bulk fracture with probable gap > 250 μm with partial loss of the restoration.

    Measured: 1 year follow up

  2. Effect of the restoration on the periodontium

    inflammation will be evaluated. Measuring device: visual and probe according to

    FDI standard (Grade 1-5), which has been defined as follows:

    Grade 1: No plaque, no inflammation of the gingival papilla. Grade 2: Minimal plaque is present, PBI equivalent to baseline. Grade 3: Difference up to one grade in severity of PBI compared to baseline and in comparison to control tooth.

    Grade 4: Difference of more than one grade of PBI worsening in comparison to control tooth or increase in pocket depth > 1 mm requiring major intervention.

    Grade 5: Severe/ acute gingivitis or periodontitis if related to the restoration requiring immediate replacement of the restoration.

    Measured: 1 year follow up

  3. Tooth cracks and fractures

    Measuring device: visual and probe according to FDI standard (Grade 1-5) Grade 1: Complete integrity of the restored tooth. Grade 2: Minor marginal crack < 150 μm wide or a hairline crack which cannot be probed. The patient has no clinical symptoms.

    Grade 3:

    (Grade 3.1) Marginal split in the enamel < 250 μm wide. Not possible to remove by polishing without compromising the shape of the tooth surface or damaging the tooth and is left untreated as not expected to cause further damage. (Grade 3.2)Crack < 250 μm. Patient has no or minimal discomfort.

    Grade 4:

    (Grade 4.1) Major marginal split > 250 μm that requires repair and/or dentin or base exposed . (Grade 4.2):A 250-μm probe/explorer can be inserted into a crack Grade 5: A cusp or major tooth fracture requiring immediate replacement.

    Measured: 1 year follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2022
  2. Study start1 Apr 2022
  3. Primary completion1 Oct 2023
  4. Study completion1 Oct 2027 (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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05281861
Sponsor's protocol ID
V.Ambria Adaptation(679/272)
Status last verified
Jan 2024
First submitted
8 Mar 2022
Last updated
30 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Falahchai M, Babaee Hemmati Y, Neshandar Asli H, Neshandar Asli M. Marginal adaptation of zirconia-reinforced lithium silicate overlays with different preparation designs. J Esthet Restor Dent. 2020 Dec;32(8):823-830. doi: 10.1111/jerd.12642. Epub 2020 Aug 18.

    PubMed 32810388

  • Guess PC, Vagkopoulou T, Zhang Y, Wolkewitz M, Strub JR. Marginal and internal fit of heat pressed versus CAD/CAM fabricated all-ceramic onlays after exposure to thermo-mechanical fatigue. J Dent. 2014 Feb;42(2):199-209. doi: 10.1016/j.jdent.2013.10.002. Epub 2013 Oct 24.

    PubMed 24161516

  • Bastos NA, Bitencourt SB, Carneiro RF, Ferrairo BM, Strelhow SSF, Dos Santos DM, Bombonatti JFS. Marginal and internal adaptation of lithium disilicate partial restorations: A systematic review and meta-analysis. J Indian Prosthodont Soc. 2020 Oct-Dec;20(4):338-344. doi: 10.4103/jips.jips_112_20. Epub 2020 Oct 8.

    PubMed 33487960

Questions about this trial

What is this clinical trial studying?

A study testing Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restoration and Lithium disilicate (IPS e-max press) ceramic onlay restoration in people with Carious Teeth and Adaptation, run by Al-Azhar 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 6 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 30 Jan 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?

This study is still under way. Results are not available in the source record yet.

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?

Marginal Adaptation (time frame: 1 year follow up). 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 NCT05281861, which also lists 3 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 30 Jan 2024.

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