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.
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
- Conditions the study is for
- Posterior Ceramic Onlays, Badly Decayed Teeth Need to be Restored , Teeth Restored With Large Filling Restorations
- 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.
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.
- Conditions
- Posterior Ceramic Onlays, Badly Decayed Teeth Need to be Restored , Teeth Restored With Large Filling 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 group | Role | What they receive |
|---|---|---|
| ceramic onlay with shoulder preparation design. | Active comparator | posterior 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 design | Experimental | posterior 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.
Fracture
measured using Modified united states public health service criteira (MUSPHS)
Measured: 1 year
Secondary outcomes (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.
- First posted18 Feb 2020
- Study start20 Feb 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Ceramic OnlaysStudies 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Mokhtar Nasr Sheded Alsedawy, Cairo University
- Investigators
- nora alsedawy, M.D.s, Principal investigator, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Evaluation of Ceramic Onlay Restorations With Different Preparation Designs
- ClinicalTrials.gov ID
- NCT04274959
- Acronym / sponsor ID
- CEBD-CU-2020-02-01
- Conditions
- Posterior Ceramic Onlays, Badly Decayed Teeth Need to be Restored , Teeth Restored With Large Filling Restorations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 18 Feb 2020 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ceramic onlay with shoulder preparation design. | Active comparator | Other: ceramic onlay with shoulder preparation design.posterior ceramic onlay restoration with shoulder design with 1 mm shoulder thickness |
| ceramic onlay with butt joint preparation design | Experimental | Other: ,ceramic onlay with butt joint preparation designposterior ceramic onlay with butt joint preparation design with flat occlusal reduction with inclined surface |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
- Able to return for follow-up examinations and evaluation
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| ceramic onlay with shoulder preparation design.ceramic onlay with shoulder preparation design which allowing the largest possible enamel for adhesion , | Other | ceramic onlay with shoulder preparation design. |
| ,ceramic onlay with butt joint preparation designceramic onlay with butt joint preparation design with cusp reduction to protect teeth from occlusal loads and cuspal fracture | Other | ceramic onlay with butt joint preparation design |
Primary outcome
Fracture
Time frame: 1 year
measured using Modified united states public health service criteira (MUSPHS)
1 secondary outcome
Marginal adaptation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Posterior Ceramic Onlays
Active, not recruiting
Clinical Evaluation of Ceramage Inlays Cemented With Beautilink Self-Adhesive Resin Cement Versus Rely X Resin Cement in Carious Posterior Teeth
Caries Class Ii
Active, not recruiting
Marginal Evaluation of Zirconia Reinforced Lithium Disilicate Partial Coverage Restoration of Egyptian Posterior Teeth.
Carious Teeth, Adaptation
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.
nora alsedawy, M.D.s principal investigator
Cairo University
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.