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Posterior Ceramic OnlaysNCT04274959

Functional Evaluation of Ceramic Onlay Restorations With Different Preparation Designs

A study testing ceramic onlay with shoulder preparation design. and ,ceramic onlay with butt joint preparation design in people with Posterior Ceramic Onlays and Badly Decayed Teeth Need to be Restored , Teeth Restored With Large Filling Restorations, run by Cairo University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Tooth preparation designs for posterior ceramic restorations have been based on traditional cast metal restoration designs, but with more occlusal tooth reduction and with a slightly increased taper. These preparations may involve the removal of considerable tooth structure. Read more about this study

Who is it for?
Ages 25 to 45 years
What is being tested?
ceramic onlay with shoulder preparation design. and ,ceramic onlay with butt joint preparation design
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
No sites listed yet
Study dates
20 Feb 2020to 1 Jun 2021
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 25 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • From 25-45 years old, be able to read and sign the informed consent document. (31)
  • Have no active periodontal or pulpal diseases, have teeth with good restorations. (32)
  • Psychologically and physically able to withstand conventional dental procedures
  • Patients with teeth problems indicated for posterior onlay.
  • Decayed teeth
  • Teeth restored with large filling restorations
  • Able to return for follow-up examinations and evaluation

Who cannot join

  • Patient less than 25 or more than 45 years
  • Patient with active resistant periodontal diseases
  • Patients with poor oral hygiene, high caries risk and uncooperative patients
  • Pregnant women
  • Patients in the growth stage with partially erupted teeth
  • Psychiatric problems or unrealistic expectations
  • Lack of opposing dentition in the area of interest.
  • The presence of a removable or fixed orthodontic appliance, signs of bruxism or clenching, the absence of more than one unit in the posterior region .

Trial locations and contacts

No sites are listed yet.

omaima elmahalawi, professor contact

01222154399

oelmahallawi@dentistry.cu.edu.eg

About this study

Tooth preparation designs for posterior ceramic restorations have been based on traditional cast metal restoration designs, but with more occlusal tooth reduction and with a slightly increased taper. These preparations may involve the removal of considerable tooth structure. As more structure is removed, higher tooth strain and lower fracture resistance may occur.5 The increased tooth structure loss may increase cuspal flexure, thereby reducing the tooth fracture resistance, or open the restoration-tooth interface .

However, it has been demonstrated that cusp recovery results in fewer failures, likely increasing the longevity of posterior ceramic restorations. Recently, minimally invasive cavity preparations for posterior indirect restorations were demonstrated to present the benefit of conservation of tooth structure, as well as improved stress distribution. However, the performance of posterior restoration is also material dependent. Due to the continuous advancements in dental ceramics and innovative manufacturing techniques.

The aim of this study is to evaluate the clinical functional performance of ceramic onlay restorations with butt joint preparation design and compare them to shoulder preparation design.

Read the detailed description

When an indirect restoration is selected as the treatment option for posterior teeth, the clinician must determine the configuration of the cavity preparation. Several designs have been proposed for preparing all-ceramic resin-bonded posterior restorations, as guided by the particular mechanical and structural characteristics of ceramic restorative materials. mechanical and structural characteristics of ceramic restorative materials. The primary causes of failure of ceramic onlay restorations are cohesive bulk fractures and marginal deficiencies, which manifest clinically as marginal discoloration and secondary caries. Tooth preparation designs for posterior ceramic restorations have been based on traditional cast metal restoration designs, but with more occlusal tooth reduction and with a slightly increased taper. These preparations may involve the removal of considerable tooth structure. As more structure is removed, higher tooth strain and lower fracture resistance may occur.5 The increased tooth structure loss may increase cuspal flexure, thereby reducing the tooth fracture resistance, or open the restoration-tooth interface .

However, it has been demonstrated that cusp recovery results in fewer failures, likely increasing the longevity of posterior ceramic restorations. Recently, minimally invasive cavity preparations for posterior indirect restorations were demonstrated to present the benefit of conservation of tooth structure, as well as improved stress distribution. However, the performance of posterior restoration is also material dependent. Due to the continuous advancements in dental ceramics and innovative manufacturing techniques.

Maximum preservation of sound tooth structure and maintenance of the vitality of restored teeth is critical for the longevity of teeth as well as restorations, especially in cases, where a large amount of tooth tissue has been lost due to wear and/or trauma. As the demand for conservative tooth treatment increases, so does the need for partial ceramic crowns. In addition to traditional cusp capping, simplified designs have been recommended in certain cases, such as fractured teeth and teeth with large caries.. According to the cusp coverage, the types of restorations can be classified as inlays, which is not covered cusps, onlays, which is covered at least one cusp, or overlays, and which is covered all cusps.

Onlay restorations not only provide superior esthetics but also minimize tooth tissue loss, making them a good treatment choice for posterior teeth with extensive cavities formed due to caries. Moreover, by covering more than one tooth cusp, onlays provide a favorable distribution of stress, reducing the risk of tooth and restoration fracture. preparation design may also play a role in tooth/restoration fracture. Some authors have shown that occlusal reduction reduces the chance of restoration failure. Others have shown that large preparation designs results in a reduced chance of possible fracture occurred in tooth tissue.

While different preparation designs have been described in the literature, the most appropriate design will vary according to the restorative material to be used. Despite the fact that partial ceramic crowns are increasingly advocated as alternative restorations for extensively damaged teeth, the literature includes limited studies examining the use of different preparation designs with this type of restoration. To date, confusing and contradictory results have been obtained regarding the effects of preparation design on the fracture resistance and stress distribution of tooth structure restored with partial ceramic crowns. Therefore, this study investigated the effects of three different preparation designs on the fracture of ceramic onlays. The hypothesis that different designs would affect the fracture resistance of onlay restorations.

Being tested
ceramic onlay with shoulder preparation design., ,ceramic onlay with butt joint preparation design

What participants receive

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

  • ceramic onlay with shoulder preparation design.Other

    ceramic onlay with shoulder preparation design which allowing the largest possible enamel for adhesion ,

  • ,ceramic onlay with butt joint preparation designOther

    ceramic onlay with butt joint preparation design with cusp reduction to protect teeth from occlusal loads and cuspal fracture

Study groups in NCT04274959
Study groupRoleWhat they receive
ceramic onlay with shoulder preparation design.Active comparatorposterior ceramic onlay restoration with shoulder design with 1 mm shoulder thickness
Receives: Other: ceramic onlay with shoulder preparation design.
ceramic onlay with butt joint preparation designExperimentalposterior ceramic onlay with butt joint preparation design with flat occlusal reduction with inclined surface
Receives: Other: ,ceramic onlay with butt joint preparation design

What is being measured

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

  1. Fracture

    measured using Modified united states public health service criteira (MUSPHS)

    Measured: 1 year

Secondary outcomes (1)
  1. Marginal adaptation

    measured using Modified united states public health service criteira (MUSPHS)

    Measured: 1 year

Timeline

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

  1. First posted18 Feb 2020
  2. Study start20 Feb 2020 (estimated)
  3. Primary completion1 Feb 2021 (estimated)
  4. Study completion1 Jun 2021 (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
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04274959
Sponsor's protocol ID
CEBD-CU-2020-02-01
Status last verified
Sep 2019
First submitted
16 Feb 2020
Last updated
18 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ceramic onlay with shoulder preparation design. and ,ceramic onlay with butt joint preparation design in people with Posterior Ceramic Onlays and Badly Decayed Teeth Need to be Restored , Teeth Restored With Large Filling Restorations, 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 7 inclusion and 8 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 18 Feb 2020. 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.

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 nora alsedawy, M.D.s (01140673739, nora.alsedawy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fracture (time frame: 1 year). 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 18 Feb 2020; AzTrials last refreshed its copy on 5 Nov 2026.

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