Single Posterior CrownsNCT05252689
Clinical Evaluation of Teeth Prepared With Vertical Preparation Versus Deep Chamfer
A study testing monolithic zirconia single posterior crowns with deep chamfer finish line and monolithic zirconia single posterior crowns with vertical finish line in people with Single Posterior Crowns and Endodontically Treated Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
It has been demonstrated that a great amount of tooth structure is lost during the prosthetic preparations of abutments for full-coverage FDPs with tooth substance removal of 63% of 73%, this aggressive loss of tooth structure usually accompanied with pain and post-operative sensitivity. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Single Posterior Crowns, Endodontically Treated Teeth, Decayed Teeth
- What is being tested?
- monolithic zirconia single posterior crowns with deep chamfer finish line and monolithic zirconia single posterior crowns with vertical finish line
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 1 Jul 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patients in this study will be in the range of 18-50 years
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Psychologically and physically able to withstand conventional dental procedures
- Able to return for follow-up examinations and evaluation
- No tooth mobility or grade 1 can be accepted
- Patients with teeth problems indicated for single posterior crowns:
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- Badly decayed teeth
- Teeth restored with large filling restorations
- Endodontically treated teeth
- Malformed teeth
- Malposed teeth (Tilted, over-erupted, rotated, etc.)
- Spacing between posterior teeth
Who cannot join
- Patients under the age of 18 or being incapable of taking out a contract
- Patient with active resistant periodontal diseases
- Patients with any medical condition that impaired correct oral hygiene
- a conspicuous medical or psychological history
- bruxism, or known allergic reaction to the materials used.
- pregnant female patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Teeth Prepared With Vertical Preparation Technique Versus Deep Chamfer for Monolithic Zirconia Crowns
It has been demonstrated that a great amount of tooth structure is lost during the prosthetic preparations of abutments for full-coverage FDPs with tooth substance removal of 63% of 73%, this aggressive loss of tooth structure usually accompanied with pain and post-operative sensitivity. In comparison with the vertical preparation technique, there is less amount of tooth substance loss. this clinical study will provide benefits for practitioners and clinicians by guiding them to choose a more conservative treatment plan with the better marginal fit, clinical performance and satisfaction for the patients on the long term. rather than other benefits like less chair time, less risk for pulp injury, less time and cost
Read the detailed description
A healthy relationship between dental restorations and the periodontium is of prime importance for the clinical longevity and esthetic harmony of full coverage restorations . One of the Most Common complications, derived from fixed prostheses is gingival recession, which constitutes an important clinical concern. This problem is largely associated with iatrogenic effects produced during dental preparation or as a result of poor prosthetic fit which can cause chronic inflammation leading to gingival margin recession around the restoration .
- Being tested
- monolithic zirconia single posterior crowns with deep chamfer finish line, monolithic zirconia single posterior crowns with vertical finish line
- Medical subject headings
- Tooth, Nonvital, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monolithic zirconia single posterior crowns with deep chamfer finish lineOther
deep chamfer of 1 mm average thickness for cervical finish line, a convergence angle of 6-12° on each side and up to 20° total, in some studies, is acceptable and occlusal reduction of 1,5-2 mm
monolithic zirconia single posterior crowns with vertical finish lineOther
using special round-ended 2 degrees tapered diamond burs a non-working tip (batt bur). It has coronal diameter of 1.2 mm, apical diameter of 0.7 mm, and non- cutting end of 1 mm, which reduces or avoids damage to the connective attachment and allows a tooth-guided preparation procedure
| Study group | Role | What they receive |
|---|---|---|
| monolithic zirconia single posterior crowns with deep chamfer finish line | Active comparator | monolithic zirconia single posterior crowns with deep chamfer finish line fabricated by cad cam machine and cemented by self adhesive resin cement. Receives: Other: monolithic zirconia single posterior crowns with deep chamfer finish line |
| monolithic zirconia single posterior crowns with vertical finish line | Experimental | monolithic zirconia single posterior crowns with vertical finish line fabricated by cad cam machine and cemented by self adhesive resin cement. Receives: Other: monolithic zirconia single posterior crowns with vertical finish line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation
Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) No visible evidences of crevice along the margins; no catch or penetration of the explorer.
Bravo (B) Visible evidence of crevice and/or catch of explorer; no penetration of the explorer.
Charlie (C) Visible evidence of crevice and penetration of the explorer.
Measured: 1 year
Secondary outcomes (3)
Fracture of the restoration
Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) Smooth surface of the restoration (shiny after air drying)
Bravo (B) Dull surface and/or chipping of porcelain that does not impair function
Charlie (C) Chipping of veneering material impairing esthetics and function and/or exposing framework material
Measured: 1 year
gingival inflammation
Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) Normal gingiva
Bravo (B) Mild inflammation - slight change in color and slight edema but no bleeding on probing;
Charlie (C) Moderate inflammation redness, edema, and glazing, bleeding on probing;
Measured: 1 year
Recurrent caries
Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) No caries present Bravo (B) Caries present
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 posted23 Feb 2022
- Study start1 Mar 2020
- Primary completion1 Mar 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Posterior CrownsStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Salah Ibrahim Afifi Elgohary, Cairo University
- Investigators
- Maha Taymour, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252689
- Sponsor's protocol ID
- CEBD-CU-2019-9-2
- Status last verified
- Apr 2022
- First submitted
- 14 Feb 2022
- Last updated
- 26 Apr 2022
- 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 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Teeth Prepared With Vertical Preparation Technique Versus Deep Chamfer for Monolithic Zirconia Crowns
- ClinicalTrials.gov ID
- NCT05252689
- Acronym / sponsor ID
- CEBD-CU-2019-9-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 23 Feb 2022 (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.
It has been demonstrated that a great amount of tooth structure is lost during the prosthetic preparations of abutments for full-coverage FDPs with tooth substance removal of 63% of 73%, this aggressive loss of tooth structure usually accompanied with pain and post-operative sensitivity. In comparison with the vertical preparation technique, there is less amount of tooth substance loss. this clinical study will provide benefits for practitioners and clinicians by guiding them to choose a more conservative treatment plan with the better marginal fit, clinical performance and satisfaction for the patients on the long term. rather than other benefits like less chair time, less risk for pulp injury, less time and cost
Detailed description
A healthy relationship between dental restorations and the periodontium is of prime importance for the clinical longevity and esthetic harmony of full coverage restorations . One of the Most Common complications, derived from fixed prostheses is gingival recession, which constitutes an important clinical concern. This problem is largely associated with iatrogenic effects produced during dental preparation or as a result of poor prosthetic fit which can cause chronic inflammation leading to gingival margin recession around the restoration .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monolithic zirconia single posterior crowns with deep chamfer finish line | Active comparator | Other: monolithic zirconia single posterior crowns with deep chamfer finish linemonolithic zirconia single posterior crowns with deep chamfer finish line fabricated by cad cam machine and cemented by self adhesive resin cement. |
| monolithic zirconia single posterior crowns with vertical finish line | Experimental | Other: monolithic zirconia single posterior crowns with vertical finish linemonolithic zirconia single posterior crowns with vertical finish line fabricated by cad cam machine and cemented by self adhesive resin cement. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- The patients in this study will be in the range of 18-50 years
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Psychologically and physically able to withstand conventional dental procedures
- Able to return for follow-up examinations and evaluation
- No tooth mobility or grade 1 can be accepted
Key exclusion criteria (6 listed)
- Patients under the age of 18 or being incapable of taking out a contract
- Patient with active resistant periodontal diseases
- Patients with any medical condition that impaired correct oral hygiene
- a conspicuous medical or psychological history
- bruxism, or known allergic reaction to the materials used.
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 |
|---|---|---|
| monolithic zirconia single posterior crowns with deep chamfer finish linedeep chamfer of 1 mm average thickness for cervical finish line, a convergence angle of 6-12° on each side and up to 20° total, in some studies, is acceptable and occlusal reduction of 1,5-2 mm | Other | monolithic zirconia single posterior crowns with deep chamfer finish line |
| monolithic zirconia single posterior crowns with vertical finish lineusing special round-ended 2 degrees tapered diamond burs a non-working tip (batt bur). It has coronal diameter of 1.2 mm, apical diameter of 0.7 mm, and non- cutting end of 1 mm, which reduces or avoids damage to the connective attachment and allows a tooth-guided preparation procedure | Other | monolithic zirconia single posterior crowns with vertical finish line |
Primary outcome
Marginal adaptation
Time frame: 1 year
Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) No visible evidences of crevice along the margins; no catch or penetration of the explorer. Bravo (B) Visible evidence of crevice and/or catch of explorer; no penetration of the explorer. Charlie (C) Visible evidence of crevice and penetration of the explorer.
3 secondary outcomes
Fracture of the restoration
Time frame: 1 year
gingival inflammation
Time frame: 1 year
Recurrent caries
Time frame: 1 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 26 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Single Posterior Crowns
Active, not recruitingObservational study
Prospective Clinical Evaluation of Posterior Single-tooth Zirconia Ceramic Restorations
Dental Crowns
Active, not recruiting
Monolithic Zirconia Posterior Single Crowns: a Randomized Clinical Trial.
Posterior Single Edentulous Sites
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.
Maha Taymour, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monolithic zirconia single posterior crowns with deep chamfer finish line and monolithic zirconia single posterior crowns with vertical finish line in people with Single Posterior Crowns and Endodontically Treated Teeth, 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 12 inclusion and 6 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 26 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?
Marginal adaptation (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 26 Apr 2022.