Missing ToothdentistryNCT03715842
Clinical Assessment Of Inlay Retained Bridge Designs (Tub Shaped And Inlay Shaped) In Missing Posterior Teeth Cases.
A study testing Tub shaped design and Inlay shaped design in people with Missing Tooth, run by Cairo University.
Trial summary
The interest in partial coverage retainers such as inlays and onlays have increased drastically because these restorations are able to provide a more conservative option requiring minimal tissue removal thus preserving healthy tooth structure to a maximum extent. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Tooth
- What is being tested?
- Tub shaped design and Inlay shaped design
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2019to 11 Apr 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- From 18-55 years old, should be able to read and sign the consent document.
- Ability to tolerate the restorative procedures (physical and psychological).
- Good oral hygiene
- Low susceptibility to decay
- Have a minimum coronal tooth height of 5 mm,
- Parallel abutments
- Sufficient mesio distal edentulous gap dimensions.
Who cannot join
- Partially erupted teeth (young)
- Bad oral hygiene and motivation
- Root canal treated teeth
- Psychiatric problems or unrealistic expectations
- Severe para-functional habits
- The absence of enamel on the preparation margins
- Extensive crown defects
- Abutment mobility
About this study
The interest in partial coverage retainers such as inlays and onlays have increased drastically because these restorations are able to provide a more conservative option requiring minimal tissue removal thus preserving healthy tooth structure to a maximum extent.
If patient rejects an implant treatment and enough sound tooth structure is available it would be desirable to restore a missing tooth with Inlay-Retained Fixed Partial Denture instead of full coverage retained one .
Read more
The use of all-ceramic materials for inlays and onlays in restorative dentistry is becoming more popular , the proper selection of restorative materials, careful preparation design and adequate adhesion between tooth/restorative material interfaces considered important factor to prevent failures .
Zirconia was introduced into dentistry in the 1990s.The high initial strength and fracture toughness of zirconia results from a physical property of partially stabilized zirconia known as transformation toughening. On the other hand, its white color, similar to the color of natural teeth and its ability to transmit light makes it useful in aesthetically important areas .
Inlay Fixed Partial Denture restoration may have increased the risk of fracture due to the relative small size of restorations compared to the complete coverage restoration. An unfavorable distribution of stresses between the ceramic inlay and tooth structure may result in marginal deterioration around the inlay or its failure.
The direction of forces on the occlusal surface of Inlay Fixed Partial Denture may lead to the phenomenon of submargination, ceramic fracture, wear at interface and postoperative hypersensitivity which remain a problem that require further investigation. One of the most important factors in the success and longevity of a restoration is to have an accurate marginal fit. Ideally, the cemented restoration should precisely meet the finish line of the prepared tooth. In reality, clinical perfection is challenging to achieve and to verify.
Read the detailed description
The tub-shaped inlay preparation design this consists of an occlusal proximal reduction featuring a 3.5-4 mm width bucco-lingually, 3-3.5mm depth occluso-gingivally and 7-7.5 mm length mesio distally for molars and 2.3-2.8mm width buccolingually, 3-3.5 mm depth occluso gingivally and 3.5-4mm length mesiodistally for premolars. when necessary, superficial extensions may also be made on the preparations so that the occlusal fossa included in the preparation area and then the susceptibility for plaque accumulation will be diminished.
Participant timeline
The visits will be designated as follows:
Visit 1: one week after allocation, preoperative records, face-to-face adherence reminder session, clinical examination, radiographic examination, intraoral photography and primary impressions for diagnostic cast construction .
Visit 2: one week after the first visit, teeth preparations, secondary impression and temporization .
Visit 3: one week after the second visit, try in for the restoration will be done.
Visit 4: one week after the try in, final cementation of the restoration.(GC resin cement) Visit 5: follow up after twelve months from the cementation visit.
The aim of the study is to assess the fracture resistance of two inlay retained bridge designs (tub shaped and inlay shaped) in missing posterior teeth cases. Based on previous papers by Ohlmann et al., 2008 7 and İzgi et al.,2011 4 indicate that the failure rate among controls is 52%. If the true failure rate for experimental subjects is 99%, we will need to study 12 in each group to be able to reject the null hypothesis that the failure rates for experimental and control subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. We will use an uncorrected chi-squared statistic to evaluate this null hypothesis. This number is to be increased to 15 in each group (25% more than the calculated) to compensate for possible losses during follow up. The sample size was calculated by PS: Power and Sample Size Calculation software Version 3.1.2 (Vanderbilt University, Nashville, Tennessee, USA).
- Conditions
- Missing Tooth
- Being tested
- Tub shaped design, Inlay shaped design
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tub shaped designOther
The tub-shaped inlay preparation design this consists of an occlusal proximal reduction featuring a 3.5-4 mm width bucco-lingually, 3-3.5mm depth occluso-gingivally and 7-7.5 mm length mesio distally for molars and 2.3-2.8mm width buccolingually, 3-3.5 mm depth occluso gingivally and 3.5-4mm length mesiodistally for premolars. when necessary, superficial extensions may also be made on the preparations so that the occlusal fossa included in the preparation area and then the susceptibility for plaque accumulation will be diminished.
Inlay shaped designOther
The occlusal inlay had a preparation depth that allowed a thickness of 2.0 mm for the ceramic. The occlusal preparation was 4 mm wide and extended 4 or 6 mm mesio-distally for the premolar or molar models, respectively. The proximal box was 1 mm wide and had approximately 5˚ divergence, extending 2 mm apical to the isthmus floor . The preparations corresponded to a proximal connector area of 3 mm × 3 mm for molars and premolars.
| Study group | Role | What they receive |
|---|---|---|
| Tub shaped design | Experimental | The tub-shaped preparation design this consists of an occlusal proximal reduction featuring a 3.5-4 mm width bucco-lingually, 3-3.5mm depth occluso-gingivally and 7-7.5 mm length mesio distally for molars and 2.3-2.8mm width buccolingually, 3-3.5 mm depth occluso gingivally and 3.5-4mm length mesiodistally for premolars. when necessary, superficial extensions may also be made on the preparations so that the occlusal fossa included in the preparation area and then the susceptibility for plaque accumulation will be diminished. Receives: Other: Tub shaped design |
| Inlay shaped design | Active comparator | The occlusal inlay had a preparation depth that allowed a thickness of 2.0 mm for the ceramic. The occlusal preparation was 4 mm wide and extended 4 or 6 mm mesio-distally for the premolar or molar models, respectively. The proximal box was 1 mm wide and had approximately 5˚ divergence, extending 2 mm apical to the isthmus floor . The preparations corresponded to a proximal connector area of 3 mm × 3 mm for molars and premolars. Receives: Other: Inlay shaped design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture
Fracture assessed by modified Ryge Criteria ( Alpha , Bravo , Charlie and Delta )
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start11 Mar 2019 (estimated)
- Primary completion11 Mar 2020 (estimated)
- Study completion11 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Missing ToothStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmoud osama, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715842
- Sponsor's protocol ID
- CEBD-CU-2018-10-08
- Acronym
- dentistry
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.
PubMed 22821429Shillingburg, H.T., Hobo, S. and Whitsett, L. (1997) Fundamentals of fixed prosthodontics. 3rd Edition, Quintessence, Chicago, 119-137, 171-174.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment Of Inlay Retained Bridge Designs (Tub Shaped And Inlay Shaped) In Missing Posterior Teeth Cases.
- ClinicalTrials.gov ID
- NCT03715842
- Acronym / sponsor ID
- dentistry / CEBD-CU-2018-10-08
- Conditions
- Missing Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Mar 2019 (estimated)
- Primary completion
- 11 Mar 2020 (estimated)
- Study completion
- 11 Apr 2020 (estimated)
- First posted
- 23 Oct 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 interest in partial coverage retainers such as inlays and onlays have increased drastically because these restorations are able to provide a more conservative option requiring minimal tissue removal thus preserving healthy tooth structure to a maximum extent.
If patient rejects an implant treatment and enough sound tooth structure is available it would be desirable to restore a missing tooth with Inlay-Retained Fixed Partial Denture instead of full coverage retained one .
The use of all-ceramic materials for inlays and onlays in restorative dentistry is becoming more popular , the proper selection of restorative materials, careful preparation design and adequate adhesion between tooth/restorative material interfaces considered important factor to prevent failures .
Zirconia was introduced into dentistry in the 1990s.The high initial strength and fracture toughness of zirconia results from a physical property of partially stabilized zirconia known as transformation toughening. On the other hand, its white color, similar to the color of natural teeth and its ability to transmit light makes it useful in aesthetically important areas .
Inlay Fixed Partial Denture restoration may have increased the risk of fracture due to the relative small size of restorations compared to the complete coverage restoration. An unfavorable distribution of stresses between the ceramic inlay and tooth structure may result in marginal deterioration around the inlay or its failure.
The direction of forces on the occlusal surface of Inlay Fixed Partial Denture may lead to the phenomenon of submargination, ceramic fracture, wear at interface and postoperative hypersensitivity which remain a problem that require further investigation. One of the most important factors in the success and longevity of a restoration is to have an accurate marginal fit. Ideally, the cemented restoration should precisely meet the finish line of the prepared tooth. In reality, clinical perfection is challenging to achieve and to verify.
Detailed description
The tub-shaped inlay preparation design this consists of an occlusal proximal reduction featuring a 3.5-4 mm width bucco-lingually, 3-3.5mm depth occluso-gingivally and 7-7.5 mm length mesio distally for molars and 2.3-2.8mm width buccolingually, 3-3.5 mm depth occluso gingivally and 3.5-4mm length mesiodistally for premolars. when necessary, superficial extensions may also be made on the preparations so that the occlusal fossa included in the preparation area and then the susceptibility for plaque accumulation will be diminished.
Participant timeline
The visits will be designated as follows:
Visit 1: one week after allocation, preoperative records, face-to-face adherence reminder session, clinical examination, radiographic examination, intraoral photography and primary impressions for diagnostic cast construction .
Visit 2: one week after the first visit, teeth preparations, secondary impression and temporization .
Visit 3: one week after the second visit, try in for the restoration will be done.
Visit 4: one week after the try in, final cementation of the restoration.(GC resin cement) Visit 5: follow up after twelve months from the cementation visit.
The aim of the study is to assess the fracture resistance of two inlay retained bridge designs (tub shaped and inlay shaped) in missing posterior teeth cases. Based on previous papers by Ohlmann et al., 2008 7 and İzgi et al.,2011 4 indicate that the failure rate among controls is 52%. If the true failure rate for experimental subjects is 99%, we will need to study 12 in each group to be able to reject the null hypothesis that the failure rates for experimental and control subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. We will use an uncorrected chi-squared statistic to evaluate this null hypothesis. This number is to be increased to 15 in each group (25% more than the calculated) to compensate for possible losses during follow up. The sample size was calculated by PS: Power and Sample Size Calculation software Version 3.1.2 (Vanderbilt University, Nashville, Tennessee, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tub shaped design | Experimental | Other: Tub shaped designThe tub-shaped preparation design this consists of an occlusal proximal reduction featuring a 3.5-4 mm width bucco-lingually, 3-3.5mm depth occluso-gingivally and 7-7.5 mm length mesio distally for molars and 2.3-2.8mm width buccolingually, 3-3.5 mm depth occluso gingivally and 3.5-4mm length mesiodistally for premolars. when necessary, superficial extensions may also be made on the preparations so that the occlusal fossa included in the preparation area and then the susceptibility for plaque accumulation will be diminished. |
| Inlay shaped design | Active comparator | Other: Inlay shaped designThe occlusal inlay had a preparation depth that allowed a thickness of 2.0 mm for the ceramic. The occlusal preparation was 4 mm wide and extended 4 or 6 mm mesio-distally for the premolar or molar models, respectively. The proximal box was 1 mm wide and had approximately 5˚ divergence, extending 2 mm apical to the isthmus floor . The preparations corresponded to a proximal connector area of 3 mm × 3 mm for molars and premolars. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- From 18-55 years old, should be able to read and sign the consent document.
- Ability to tolerate the restorative procedures (physical and psychological).
- Good oral hygiene
- Low susceptibility to decay
- Have a minimum coronal tooth height of 5 mm,
Key exclusion criteria (8 listed)
- Partially erupted teeth (young)
- Bad oral hygiene and motivation
- Root canal treated teeth
- Psychiatric problems or unrealistic expectations
- Severe para-functional habits
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 |
|---|---|---|
| Tub shaped designThe tub-shaped inlay preparation design this consists of an occlusal proximal reduction featuring a 3.5-4 mm width bucco-lingually, 3-3.5mm depth occluso-gingivally and 7-7.5 mm length mesio distally for molars and 2.3-2.8mm width buccolingually, 3-3.5 mm depth occluso gingivally and 3.5-4mm length mesiodistally for premolars. when necessary, superficial extensions may also be made on the preparations so that the occlusal fossa included in the preparation area and then the susceptibility for plaque accumulation will be diminished. | Other | Tub shaped design |
| Inlay shaped designThe occlusal inlay had a preparation depth that allowed a thickness of 2.0 mm for the ceramic. The occlusal preparation was 4 mm wide and extended 4 or 6 mm mesio-distally for the premolar or molar models, respectively. The proximal box was 1 mm wide and had approximately 5˚ divergence, extending 2 mm apical to the isthmus floor . The preparations corresponded to a proximal connector area of 3 mm × 3 mm for molars and premolars. | Other | Inlay shaped design |
Primary outcome
Fracture
Time frame: one year
Fracture assessed by modified Ryge Criteria ( Alpha , Bravo , Charlie and Delta )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Background: PubMed 22821429Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.
- BackgroundShillingburg, H.T., Hobo, S. and Whitsett, L. (1997) Fundamentals of fixed prosthodontics. 3rd Edition, Quintessence, Chicago, 119-137, 171-174.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tub shaped design and Inlay shaped design in people with Missing Tooth, 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 23 Oct 2018. 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?
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?
Fracture (time frame: one year). 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 NCT03715842, which also lists 2 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 23 Oct 2018.