Gingival InflammationNCT04052490
Evaluation Of Zirconia Crowns Restoring Endodontically Treated Posterior Teeth With Two Finish Line Designs And Occlusal Reduction Schemes
A study testing Abutment with flat occlusal reduction with feather edge finish in people with Gingival Inflammation, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the clinical performance of two finish line designs (feather edge and rounded shoulder) in relation with two occlusal designs (flat and planar) in endodontically treated teeth restored with zirconia crowns. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Inflammation
- What is being tested?
- Abutment with flat occlusal reduction with feather edge finish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Oct 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- From 21-50 years old, be able to read and sign the informed consent document.
- Have no active periodontal or periapical diseases.
- Psychologically and physically able to withstand conventional dental procedures.
- Maintenance of good oral hygiene.
- Patients with teeth problems indicated for single posterior crowns:
- Badly decayed teeth
Show all 11Show fewer
- Sufficient occluso-gingival tooth height
- Endodontically treated teeth
- No tooth mobility or grade 1 can be accepted.
- No furcation involvement.
- Able to return for follow-up examinations and evaluation.
Who cannot join
- Patients with defective root canal treatment
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene 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
- Patients with bruxism.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the clinical performance of two finish line designs (feather edge and rounded shoulder) in relation with two occlusal designs (flat and planar) in endodontically treated teeth restored with zirconia crowns.
Read the detailed description
Several studies have been investigating the effect of preparation design and its relation to the marginal adaptation. Habib et al 2014 compared the accuracy of marginal and internal adaptation of zirconia copings fabricated on anatomic (A), semi-anatomic (SA) and non-anatomic (NA) occlusal surface preparations. The internal \& marginal fit were measured under electron microscope at 9 standardized areas .The anatomical occlusal preparation had better marginal and internal adaptation of Zr copings. Lima et al 2018 studied the influence of two different occlusal preparation designs on the marginal adaptation of CAD-CAM onlay restorations. The conventional anatomical occlusal preparation with a 1.2-mm modified shoulder finish line extending on the buccal surface and modified preparation flat cuspal reduction without shoulder finish line. The results showed that the conventional anatomical occlusal preparation had significantly better marginal adaptation than that of the flat cuspal preparation. Succeeding these studies, it was of interest to investigate whether or not the occlusal scheme could influence the marginal accuracy of the CAD/CAM crowns fabricated with Zirconia ceramic material.
Studies correlating between the finish line design and occlusal scheme in literature are scarce, with little evidence regarding their effect on precision fit properties of restorations. Abdullah et al 2017 evaluated the effect of using different finishing line designs with different occlusal surface reduction schemes on the vertical marginal fit of full contour CAD/CAM zirconia crown restorations. They found a direct correlation between both the finish line geometry and the occlusal design. In recent literature, the use of feather edge finish line with all ceramic restorations is a point of conflict. Fuzzi et al 2017 studied the nanoleakage and internal adaptations of lithium disilicate and zirconia crowns with featheredge finish lines. They recommended only zirconia with this finish line configuration due to its high fracture resistance when used in thin sections. Thus, the current study was conducted to examine this finish line effect on the marginal precision fit. Our hypothesis is there will be no difference in the clinical performance between the flat occlusal scheme with feather edge or rounded shoulder finish line and the planar occlusal scheme with rounded shoulder finish line configuration.
The rationale for carrying out the trial:
The influence of different tooth preparation designs can affect the success of the full coverage restorations. Still, there is no available research dealing with the effect of finishing line designs in combination with different occlusal reduction schemes on the marginal fit of full contour zirconia crowns.
- Conditions
- Gingival Inflammation
- Being tested
- Abutment with flat occlusal reduction with feather edge finish
- Keywords
- Zirconia,, occlusal scheme,, endodontically treated teeth,, finishline designs.
- Medical subject headings
- Gingivitis, Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abutment with flat occlusal reduction with feather edge finishOther
Also called Experimental: Abutment with flat occlusal reduction with shoulder finish line
Non vital teeth require a full coverage restoration to withstand the functional stresses and prevent any further destruction of tooth/crown complex. The zirconia all-ceramic crowns yield a high flexure strength and are used as an esthetic alternative to ceramo-metallic crowns. Several studies linked the effect of preparation designs to the survival of the restoration. Others, studied the effect of the finish line geometries as deep chamfer and shoulder on the marginal integrity of restorations. The feather edge finish line is used with zirconia crowns with limited data regarding its success. However, there is no presented research dealing with the effect of finishing line designs in combination with different occlusal reduction schemes on the marginal fit of full contour zirconia crowns.
| Study group | Role | What they receive |
|---|---|---|
| flat occlusal reduction with feather edge finish | Experimental | Not described Receives: Other: Abutment with flat occlusal reduction with feather edge finish |
| flat occlusal reduction with shoulder finish line | Experimental | Not described Receives: Other: Abutment with flat occlusal reduction with feather edge finish |
| planar occlusal reduction with shoulder finish line | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical performance in terms of the marginal adaptation of the groups
examination will follow the USPHS criteria.
Measured: One-Year
Secondary outcomes (4)
the fracture of the restoration
examination will follow the USPHS criteria.
Measured: One-year
marginal discoloration
examination will follow the USPHS criteria.
Measured: One-year
secondary caries
examination will follow the USPHS criteria.
Measured: One-year
gingival response
examination will follow the gingival index criteria
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 posted9 Aug 2019
- Study start1 Oct 2019
- Primary completion31 Jul 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival InflammationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Samir Fathy El-Ashkar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052490
- Sponsor's protocol ID
- CEBC-CU-2019915
- Status last verified
- Apr 2022
- First submitted
- 7 Aug 2019
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Zirconia Crowns Restoring Endodontically Treated Posterior Teeth With Two Finish Line Designs And Occlusal Reduction Schemes
- ClinicalTrials.gov ID
- NCT04052490
- Acronym / sponsor ID
- CEBC-CU-2019915
- Conditions
- Gingival Inflammation
- Keywords
- Zirconia,, occlusal scheme,, endodontically treated teeth,, finishline designs.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 9 Aug 2019 (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 aim of this study is to evaluate the clinical performance of two finish line designs (feather edge and rounded shoulder) in relation with two occlusal designs (flat and planar) in endodontically treated teeth restored with zirconia crowns.
Detailed description
Several studies have been investigating the effect of preparation design and its relation to the marginal adaptation. Habib et al 2014 compared the accuracy of marginal and internal adaptation of zirconia copings fabricated on anatomic (A), semi-anatomic (SA) and non-anatomic (NA) occlusal surface preparations. The internal \& marginal fit were measured under electron microscope at 9 standardized areas .The anatomical occlusal preparation had better marginal and internal adaptation of Zr copings. Lima et al 2018 studied the influence of two different occlusal preparation designs on the marginal adaptation of CAD-CAM onlay restorations. The conventional anatomical occlusal preparation with a 1.2-mm modified shoulder finish line extending on the buccal surface and modified preparation flat cuspal reduction without shoulder finish line. The results showed that the conventional anatomical occlusal preparation had significantly better marginal adaptation than that of the flat cuspal preparation. Succeeding these studies, it was of interest to investigate whether or not the occlusal scheme could influence the marginal accuracy of the CAD/CAM crowns fabricated with Zirconia ceramic material.
Studies correlating between the finish line design and occlusal scheme in literature are scarce, with little evidence regarding their effect on precision fit properties of restorations. Abdullah et al 2017 evaluated the effect of using different finishing line designs with different occlusal surface reduction schemes on the vertical marginal fit of full contour CAD/CAM zirconia crown restorations. They found a direct correlation between both the finish line geometry and the occlusal design. In recent literature, the use of feather edge finish line with all ceramic restorations is a point of conflict. Fuzzi et al 2017 studied the nanoleakage and internal adaptations of lithium disilicate and zirconia crowns with featheredge finish lines. They recommended only zirconia with this finish line configuration due to its high fracture resistance when used in thin sections. Thus, the current study was conducted to examine this finish line effect on the marginal precision fit. Our hypothesis is there will be no difference in the clinical performance between the flat occlusal scheme with feather edge or rounded shoulder finish line and the planar occlusal scheme with rounded shoulder finish line configuration.
The rationale for carrying out the trial:
The influence of different tooth preparation designs can affect the success of the full coverage restorations. Still, there is no available research dealing with the effect of finishing line designs in combination with different occlusal reduction schemes on the marginal fit of full contour zirconia crowns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| flat occlusal reduction with feather edge finish | Experimental | Other: Abutment with flat occlusal reduction with feather edge finish |
| flat occlusal reduction with shoulder finish line | Experimental | Other: Abutment with flat occlusal reduction with feather edge finish |
| planar occlusal reduction with shoulder finish line | No intervention | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- From 21-50 years old, be able to read and sign the informed consent document.
- Have no active periodontal or periapical diseases.
- Psychologically and physically able to withstand conventional dental procedures.
- Maintenance of good oral hygiene.
- Patients with teeth problems indicated for single posterior crowns:
Key exclusion criteria (8 listed)
- Patients with defective root canal treatment
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene 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 |
|---|---|---|
| Abutment with flat occlusal reduction with feather edge finishAlso: Experimental: Abutment with flat occlusal reduction with shoulder finish lineNon vital teeth require a full coverage restoration to withstand the functional stresses and prevent any further destruction of tooth/crown complex. The zirconia all-ceramic crowns yield a high flexure strength and are used as an esthetic alternative to ceramo-metallic crowns. Several studies linked the effect of preparation designs to the survival of the restoration. Others, studied the effect of the finish line geometries as deep chamfer and shoulder on the marginal integrity of restorations. The feather edge finish line is used with zirconia crowns with limited data regarding its success. However, there is no presented research dealing with the effect of finishing line designs in combination with different occlusal reduction schemes on the marginal fit of full contour zirconia crowns. | Other | flat occlusal reduction with feather edge finish, flat occlusal reduction with shoulder finish line |
Primary outcome
clinical performance in terms of the marginal adaptation of the groups
Time frame: One-Year
examination will follow the USPHS criteria.
4 secondary outcomes
the fracture of the restoration
Time frame: One-year
marginal discoloration
Time frame: One-year
secondary caries
Time frame: One-year
gingival response
Time frame: One-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abutment with flat occlusal reduction with feather edge finish in people with Gingival Inflammation, 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 11 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: finished, as of the sponsor's last update on 15 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
clinical performance in terms of the marginal adaptation of the groups (time frame: One-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 15 Apr 2022.