Mutilated TeethNCT06539546
Shade Matching and Patient Satisfaction of Yttria Stabilized Multilayered Zirconia and Lithium Disilicate Restorations
A study testing Yttria stabilized multilayered (YML) zirconia restorations and Lithium disilicate restorations in people with Mutilated Teeth and Endodontically Treated Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to determine whether Yttria stabilized multilayered zirconia restorations will differ from lithium disilicate restorations in shade matching and patient satisfaction in patients requiring full coverage restorations. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Mutilated Teeth, Endodontically Treated Teeth
- What is being tested?
- Yttria stabilized multilayered (YML) zirconia restorations and Lithium disilicate restorations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 20 Jun 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range of the patients from 20-60 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
- Patients able physically and psychologically to tolerate conventional restorative procedures.
- Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
- Patients with teeth problems indicated for full coverage restoration (coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
- Patients with root canal treated teeth requiring full coverage restorations.
- Patients willing to return for follow-up examinations and evaluation.
Who cannot join
- Patients in the growth stage with partially erupted teeth.
- Patients with poor oral hygiene and motivation.
- Patients with psychiatric problems or unrealistic expectations (patient that has phobia from dental treatments or needle bunch).
- Patients suffer from parafunctional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shade Matching and Patient Satisfaction of Yttria Stabilized Multilayered Zirconia and Lithium Disilicate Restorations: a Randomized Controlled Clinical Trial
The aim of the study is to determine whether Yttria stabilized multilayered zirconia restorations will differ from lithium disilicate restorations in shade matching and patient satisfaction in patients requiring full coverage restorations.
Read the detailed description
Steps in short: Single tooth in the esthetic zone requiring full coverage crown is prepared to receive an all-ceramic crown, The restorations will be divided into two groups: I: Teeth receiving restorations fabricated from Lithium disilicate II: Teeth receiving restorations fabricated from yttria stabilized multilayered zirconia. Shade will be measured using intraoral spectrophotometer and evaluated. The colour difference (ΔE) will be calculated for each sample using the following equation: ΔE =[(ΔL) ²+(Δa) ² + (Δb) ²] ½, ΔE (perceptibility threshold) will be evaluated for each group. Participant timeline the patient will be treated in visits designated as follows: Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radiographic for examination, intraoral photographs and primary impression (Alginate impression) diagnostic cast construction. Visit 2: teeth preparation and secondary impression using addition silicone rubber base material and temporary restoration. Visit 3: placement and permanent cementation of the final restoration using resin cement.
- Conditions
- Mutilated Teeth, Endodontically Treated Teeth
- Being tested
- Yttria stabilized multilayered (YML) zirconia restorations, Lithium disilicate restorations
- Keywords
- Shade match, patient satisfaction, Yttria stabilized multilayered zirconia, Lithium disilicate
- Medical subject headings
- Tooth, Nonvital, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttria stabilized multilayered (YML) zirconia restorationsOther
Yttria stabilized multilayered zirconia restorations were claimed to have high strength and esthetics at the same time but no clinical studies were conducted yet to prove its high esthetic properties
Lithium disilicate restorationsOther
Lithium disilicate reinforced glass ceramics are considered a gold standard for monolithic esthetic restorations.
| Study group | Role | What they receive |
|---|---|---|
| Yttria stabilized multilayered (YML) zirconia restorations | Experimental | Full coverage Yttria stabilized multilayered (YML) zirconia restorations will be fabricated on a tooth requiring full coverage in the esthetic zone. Receives: Other: Yttria stabilized multilayered (YML) zirconia restorations |
| Lithium disilicate restorations | Experimental | Full coverage Lithium disilicate restorations will be fabricated on a tooth requiring full coverage in the esthetic zone. Receives: Other: Lithium disilicate restorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color difference
By Intraoral Spectrophotometer, color difference between the restoration and the adjacent or contralateral natural tooth will be measured by the unit (ΔE), (ΔE) will be measured for each sample.
Measured: immediate after cementation
Secondary outcomes (1)
Patient satisfaction
By Visual Analogue Scale, with score range from 1 to 10 , where 1 is the worst (lowest satisfaction) and 10 is the best (highest satisfaction).
Measured: immediate after cementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Sep 2024
- Primary completion20 Jun 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mutilated TeethStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539546
- Sponsor's protocol ID
- PROSF 3.3.6
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shade Matching and Patient Satisfaction of Yttria Stabilized Multilayered Zirconia and Lithium Disilicate Restorations: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06539546
- Acronym / sponsor ID
- PROSF 3.3.6
- Conditions
- Mutilated Teeth, Endodontically Treated Teeth
- Keywords
- Shade match, patient satisfaction, Yttria stabilized multilayered zirconia, Lithium disilicate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 6 Aug 2024 (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 the study is to determine whether Yttria stabilized multilayered zirconia restorations will differ from lithium disilicate restorations in shade matching and patient satisfaction in patients requiring full coverage restorations.
Detailed description
Steps in short: Single tooth in the esthetic zone requiring full coverage crown is prepared to receive an all-ceramic crown, The restorations will be divided into two groups: I: Teeth receiving restorations fabricated from Lithium disilicate II: Teeth receiving restorations fabricated from yttria stabilized multilayered zirconia. Shade will be measured using intraoral spectrophotometer and evaluated. The colour difference (ΔE) will be calculated for each sample using the following equation: ΔE =[(ΔL) ²+(Δa) ² + (Δb) ²] ½, ΔE (perceptibility threshold) will be evaluated for each group. Participant timeline the patient will be treated in visits designated as follows: Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radiographic for examination, intraoral photographs and primary impression (Alginate impression) diagnostic cast construction. Visit 2: teeth preparation and secondary impression using addition silicone rubber base material and temporary restoration. Visit 3: placement and permanent cementation of the final restoration using resin cement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yttria stabilized multilayered (YML) zirconia restorations | Experimental | Other: Yttria stabilized multilayered (YML) zirconia restorationsFull coverage Yttria stabilized multilayered (YML) zirconia restorations will be fabricated on a tooth requiring full coverage in the esthetic zone. |
| Lithium disilicate restorations | Experimental | Other: Lithium disilicate restorationsFull coverage Lithium disilicate restorations will be fabricated on a tooth requiring full coverage in the esthetic zone. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age range of the patients from 20-60 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
- Patients able physically and psychologically to tolerate conventional restorative procedures.
- Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
- Patients with teeth problems indicated for full coverage restoration (coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
- Patients with root canal treated teeth requiring full coverage restorations.
Key exclusion criteria (4 listed)
- Patients in the growth stage with partially erupted teeth.
- Patients with poor oral hygiene and motivation.
- Patients with psychiatric problems or unrealistic expectations (patient that has phobia from dental treatments or needle bunch).
- Patients suffer from parafunctional 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 |
|---|---|---|
| Yttria stabilized multilayered (YML) zirconia restorationsYttria stabilized multilayered zirconia restorations were claimed to have high strength and esthetics at the same time but no clinical studies were conducted yet to prove its high esthetic properties | Other | Yttria stabilized multilayered (YML) zirconia restorations |
| Lithium disilicate restorationsLithium disilicate reinforced glass ceramics are considered a gold standard for monolithic esthetic restorations. | Other | Lithium disilicate restorations |
Primary outcome
Color difference
Time frame: immediate after cementation
By Intraoral Spectrophotometer, color difference between the restoration and the adjacent or contralateral natural tooth will be measured by the unit (ΔE), (ΔE) will be measured for each sample.
1 secondary outcome
Patient satisfaction
Time frame: immediate after cementation
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 21 Oct 2026.
Related trials for Mutilated Teeth
Not yet recruiting
Zirconia Crowns Versus Extraction of Primary Anterior Teeth
Early Childhood Caries (ECC)
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 Yttria stabilized multilayered (YML) zirconia restorations and Lithium disilicate restorations in people with Mutilated Teeth 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 6 inclusion and 4 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 21 Oct 2026. 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?
Color difference (time frame: immediate after cementation). 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 21 Oct 2026.