Monolithic Zirconia EndocrownsNCT07461597
Effect of Fabrication Monolithic Zirconia Endocrown on Marginal Integrity
A study testing Digital Intraoral Scanning in people with Monolithic Zirconia Endocrowns, run by MAAElgammal at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the marginal integrity and patient satisfaction of two different impression techniques for monolithic zirconia endocrowns. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Monolithic Zirconia Endocrowns
- What is being tested?
- Digital Intraoral Scanning
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Mar 2024
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All subjects are required to be:
- Age range of the patients from 15-50 years old, who could read understand and write to sign the consent by himself /herself.
- Patients able physically and psychologically to tolerate conventional restorative procedures.
- Patients with an asymptomatic properly treated root canal molar with no active periodontal or apical lesions, indicated for endocrown restorations.
- Presence of teeth in opposite arch with normal occlusal relation and casts could be assembled for bite registration.
- Supra-gingival margin after preparation.
- Patients willing to return for follow-up examinations and evaluation.
Who cannot join
- Patients who cannot read or write ,or have improper physical status
- Patients in the growth stage with partially erupted teeth.
- Patients with poor oral hygiene and motivation.
- Patients with parafunctional habits.
- Patients with active periodontal or periapical disease.
- Patients with improper root canal treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry Minia University
Minya, Minya Governorate, 61111
About this study
Official title: Clinical Assessment of The Effect of Fabrication Monolithic Zirconia Endocrown by Using Scanning and Conventional Impressions on Marginal Integrity
The aim of this study is to evaluate the marginal integrity and patient satisfaction of two different impression techniques for monolithic zirconia endocrowns.
Read the detailed description
The successful restoration of endodontically treated teeth is dependent on the type and quality of the coronal restoration. Endodontically treated teeth restored with crowns have a 5-year survival rate similar to vital teeth restored with crowns (94.2% versus 95%).(1,2) However, in the absence of cuspal coverage (restored with composite resin), endodontically treated teeth have a lower success rate, with a 5-year survival rate of 63%. The improved survival of teeth treated endodontically with satisfactory coronal cuspal coverage has been attributed to a reduction in microleakages and the preservation and protection of the remaining tooth structure.(3) Immediate placement of a satisfactory coronal restoration has been reported to reduce microleakage and subsequently decrease the risk of endodontic treatment failure, while cuspal coverage and preservation of the remaining coronal tooth structure have been reported to improve fracture resistance and the outcome of the endodontically treated tooth.(4) Despite the clinical success of intraradicular posts for the restoration of endodontically treated teeth, they require removal of additional sound tooth structure for optimal adaptation of the post in the root canal system, affecting the biomechanical behavior of the restored tooth.(5) Endocrowns are 1-piece restorations comprising a coronal part and a cavity part in the pulp chamber that were introduced following advances in adhesive bonding techniques. Endocrowns are indicated for molar teeth with short roots, severely curved roots, fragile or resorbed roots, and limited interarch space.(6) Marginal adaptation is the most important criterion determining the long-term functional success of a restoration. Marginal discrepancy increases the plaque retention and inflammation of periodontal tissue and secondary caries, leading to eventual failure of the restoration. A consensus regarding the maximum clinically acceptable marginal gap is lacking, but values between 50 and 200 mm have been reported. Nonetheless, most authors use the threshold mentioned by McLean and von Fraunhofer, who evaluated over 1000 crowns and reported that the maximum acceptable marginal gap was0 120 mm.(7,8,9) All-ceramic endocrowns are bonded to the tooth using adhesive resins creating strong bonds to the tooth structure resulting in strengthening effect and reducing the need for post and core. various CAD/CAM materials can be used for the fabrication of endocrowns including lithium-disilicate reinforced glassceramics, monolithic zirconia, feldspathic ceramics, in ceram alumina and in ceram spinell as well as hybrid ceramics and composites.(10)
- a.2 Description of research question P: Participants: Patients having endodontically treated molars indicated for endocrown. I: Intervention: Endocrown fabricated using intra oral scan. C: Comparator : Endocrown fabricated using traditional impressions. O: Outcome name, measuring device \& measuring unit Outcome name: Marginal integrity Clinical performance. Measuring Device : Modified USPHS criteria. (11,12,13) Measuring Unit : Categorical. S: Randomized clinical trial (RCT) T: one year 6.a. 3 Formulated question: In patients with endodontically treated teeth requiring endocrown restorations, will impression techniques of endocrowns could affect the clinical performance and patient satisfaction? 6. a. 4 The justification for undertaking the study: One of the conservative approaches that has been developed with the advances of adhesive and bonding techniques is the endocrown restoration, which is a monoblock restoration that has the ability to restore a severely destructed endodontically posterior teeth. It follows the concept of minimal invasive preparation as it gains its retention and stability from anchoring to the internal part of the pulp chamber and the cavity margins.(14,15) Endocrown restorations may be fabricated either by intra oral scanning or by traditional impressions. Endocrown restoration approach has gained more popularity, due to its advantages in providing better aesthetics, better mechanical performance, less removing of sound tooth tissues, and less clinical time.(16,17) Endocrown restoration has been considered as a reliable alternative to the conventional restoration of severely damaged posterior teeth.(18,19) Along with the surface treatment of tooth structure by acid etching and application of bonding agents. It also has adequate mechanical and sufficient strength to be used in single and short span bridges up to the premolar areas combined with having acceptable clinical margins and internal adaptation. (20,21)
6.a.5 Rationale: Elastomeric impression materials have been successfully used for the fabrication of restorations for many years.(22) However, despite the advances in impression material technology, a number of factors such as the impression technique, impression material, transfer to and from the dental laboratory, disinfection techniques, impression trays, and mixing techniques can significantly affect the accuracy of impressions. Moreover, the conventional impression technique may be associated with patient discomfort, nausea, and the unpleasant taste of the impression material. (23)
Benefits of the research to the patient:
Patient will receive a restoration with superior marginal integrity and quality.
It will provide the patient with long-term predictable prosthetic outcome.
Benefits of the research to the clinician:
Practitioner will have the advantage to assess a different fabrication techniques that can be used in different situations for better marginal integrity outcomes. It will improve patient's confidence with the dentist. 6.b. Explanation for choice of comparators: The (CAD-CAM) technique includes intraoral digital scanning, designing and fabrication of definitive endocrowns with high marginal integrity, fewer fabrication steps than the conventional technique, faster processing time, lower cost and some limitations of the conventional technique are avoided. (CAD-CAM) technology also allows access to novel biomaterials such as monolithic zirconia.(24,25)
- Conditions
- Monolithic Zirconia Endocrowns
- Being tested
- Digital Intraoral Scanning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Intraoral ScanningDevice
Digital Intraoral Scanning technique
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of endocrowns with Alpha, Bravo, or Charlie marginal integrity scores assessed using modified USPHS criteria.
Marginal integrity of the endocrowns will be clinically evaluated using the modified United States Public Health Service (USPHS) criteria using a sharp dental explorer. Each restoration will be scored as Alpha (ideal marginal adaptation), Bravo (clinically acceptable marginal discrepancy), or Charlie (clinically unacceptable). The number of restorations in each score category will be recorded and compared between the intraoral scanning group and the conventional impression group.
Measured: Baseline, 3 months, 6 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Jan 2023
- Primary completion1 Jan 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monolithic Zirconia EndocrownsStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- MAAElgammal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MAAElgammal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461597
- Sponsor's protocol ID
- CAFMZE
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of The Effect of Fabrication Monolithic Zirconia Endocrown by Using Scanning and Conventional Impressions on Marginal Integrity
- ClinicalTrials.gov ID
- NCT07461597
- Acronym / sponsor ID
- CAFMZE
- Conditions
- Monolithic Zirconia Endocrowns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- MAAElgammalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 10 Mar 2026 (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 marginal integrity and patient satisfaction of two different impression techniques for monolithic zirconia endocrowns.
Detailed description
The successful restoration of endodontically treated teeth is dependent on the type and quality of the coronal restoration. Endodontically treated teeth restored with crowns have a 5-year survival rate similar to vital teeth restored with crowns (94.2% versus 95%).(1,2) However, in the absence of cuspal coverage (restored with composite resin), endodontically treated teeth have a lower success rate, with a 5-year survival rate of 63%. The improved survival of teeth treated endodontically with satisfactory coronal cuspal coverage has been attributed to a reduction in microleakages and the preservation and protection of the remaining tooth structure.(3) Immediate placement of a satisfactory coronal restoration has been reported to reduce microleakage and subsequently decrease the risk of endodontic treatment failure, while cuspal coverage and preservation of the remaining coronal tooth structure have been reported to improve fracture resistance and the outcome of the endodontically treated tooth.(4) Despite the clinical success of intraradicular posts for the restoration of endodontically treated teeth, they require removal of additional sound tooth structure for optimal adaptation of the post in the root canal system, affecting the biomechanical behavior of the restored tooth.(5) Endocrowns are 1-piece restorations comprising a coronal part and a cavity part in the pulp chamber that were introduced following advances in adhesive bonding techniques. Endocrowns are indicated for molar teeth with short roots, severely curved roots, fragile or resorbed roots, and limited interarch space.(6) Marginal adaptation is the most important criterion determining the long-term functional success of a restoration. Marginal discrepancy increases the plaque retention and inflammation of periodontal tissue and secondary caries, leading to eventual failure of the restoration. A consensus regarding the maximum clinically acceptable marginal gap is lacking, but values between 50 and 200 mm have been reported. Nonetheless, most authors use the threshold mentioned by McLean and von Fraunhofer, who evaluated over 1000 crowns and reported that the maximum acceptable marginal gap was0 120 mm.(7,8,9) All-ceramic endocrowns are bonded to the tooth using adhesive resins creating strong bonds to the tooth structure resulting in strengthening effect and reducing the need for post and core. various CAD/CAM materials can be used for the fabrication of endocrowns including lithium-disilicate reinforced glassceramics, monolithic zirconia, feldspathic ceramics, in ceram alumina and in ceram spinell as well as hybrid ceramics and composites.(10)
- a.2 Description of research question P: Participants: Patients having endodontically treated molars indicated for endocrown. I: Intervention: Endocrown fabricated using intra oral scan. C: Comparator : Endocrown fabricated using traditional impressions. O: Outcome name, measuring device \& measuring unit Outcome name: Marginal integrity Clinical performance. Measuring Device : Modified USPHS criteria. (11,12,13) Measuring Unit : Categorical. S: Randomized clinical trial (RCT) T: one year 6.a. 3 Formulated question: In patients with endodontically treated teeth requiring endocrown restorations, will impression techniques of endocrowns could affect the clinical performance and patient satisfaction? 6. a. 4 The justification for undertaking the study: One of the conservative approaches that has been developed with the advances of adhesive and bonding techniques is the endocrown restoration, which is a monoblock restoration that has the ability to restore a severely destructed endodontically posterior teeth. It follows the concept of minimal invasive preparation as it gains its retention and stability from anchoring to the internal part of the pulp chamber and the cavity margins.(14,15) Endocrown restorations may be fabricated either by intra oral scanning or by traditional impressions. Endocrown restoration approach has gained more popularity, due to its advantages in providing better aesthetics, better mechanical performance, less removing of sound tooth tissues, and less clinical time.(16,17) Endocrown restoration has been considered as a reliable alternative to the conventional restoration of severely damaged posterior teeth.(18,19) Along with the surface treatment of tooth structure by acid etching and application of bonding agents. It also has adequate mechanical and sufficient strength to be used in single and short span bridges up to the premolar areas combined with having acceptable clinical margins and internal adaptation. (20,21)
6.a.5 Rationale: Elastomeric impression materials have been successfully used for the fabrication of restorations for many years.(22) However, despite the advances in impression material technology, a number of factors such as the impression technique, impression material, transfer to and from the dental laboratory, disinfection techniques, impression trays, and mixing techniques can significantly affect the accuracy of impressions. Moreover, the conventional impression technique may be associated with patient discomfort, nausea, and the unpleasant taste of the impression material. (23)
Benefits of the research to the patient:
Patient will receive a restoration with superior marginal integrity and quality.
It will provide the patient with long-term predictable prosthetic outcome.
Benefits of the research to the clinician:
Practitioner will have the advantage to assess a different fabrication techniques that can be used in different situations for better marginal integrity outcomes. It will improve patient's confidence with the dentist. 6.b. Explanation for choice of comparators: The (CAD-CAM) technique includes intraoral digital scanning, designing and fabrication of definitive endocrowns with high marginal integrity, fewer fabrication steps than the conventional technique, faster processing time, lower cost and some limitations of the conventional technique are avoided. (CAD-CAM) technology also allows access to novel biomaterials such as monolithic zirconia.(24,25)
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age range of the patients from 15-50 years old, who could read understand and write to sign the consent by himself /herself.
- Patients able physically and psychologically to tolerate conventional restorative procedures.
- Patients with an asymptomatic properly treated root canal molar with no active periodontal or apical lesions, indicated for endocrown restorations.
- Presence of teeth in opposite arch with normal occlusal relation and casts could be assembled for bite registration.
- Supra-gingival margin after preparation.
Key exclusion criteria (6 listed)
- Patients who cannot read or write ,or have improper physical status
- Patients in the growth stage with partially erupted teeth.
- Patients with poor oral hygiene and motivation.
- Patients with parafunctional habits.
- Patients with active periodontal or periapical disease.
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 |
|---|---|---|
| Digital Intraoral ScanningDigital Intraoral Scanning technique | Device | – |
Primary outcome
Number of endocrowns with Alpha, Bravo, or Charlie marginal integrity scores assessed using modified USPHS criteria.
Time frame: Baseline, 3 months, 6 months, and 12 months.
Marginal integrity of the endocrowns will be clinically evaluated using the modified United States Public Health Service (USPHS) criteria using a sharp dental explorer. Each restoration will be scored as Alpha (ideal marginal adaptation), Bravo (clinically acceptable marginal discrepancy), or Charlie (clinically unacceptable). The number of restorations in each score category will be recorded and compared between the intraoral scanning group and the conventional impression group.
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 10 Mar 2026.
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 Digital Intraoral Scanning in people with Monolithic Zirconia Endocrowns, run by MAAElgammal 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 7 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 10 Mar 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?
Number of endocrowns with Alpha, Bravo, or Charlie marginal integrity scores assessed using modified USPHS criteria. (time frame: Baseline, 3 months, 6 months, and 12 months.). 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 10 Mar 2026.