Gross Material Loss in Endodontically Treated Upper and Lower MolarsNCT06850649
Clinical Performance of 3D-Printed vs. Milled Endocrowns
A study testing endocrowns in people with Gross Material Loss in Endodontically Treated Upper and Lower Molars and No Systemic Infection, run by Gulcan COSKUN AKAR at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to examine the durability of endocrowns, created using various materials and manufacturing techniques with a fully digital workflow, and their ability to maintain functionality and aesthetics in the oral cavity. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Gross Material Loss in Endodontically Treated Upper and Lower Molars, No Systemic Infection, Gingival Steps Should be at Gum Level
- What is being tested?
- endocrowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 15 May 2025
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be a lower or upper molar tooth
- Must be periodontal healthy
- There must be at least two axial walls in the relevant tooth
- Gingival steps should be at gum level
- There must be neighboring teeth mesial and distal to the relevant tooth.
- The place where it occludes must be the opposing tooth and the tooth must be a natural or filled tooth without a prosthesis.
- No systemic acut or chronic conditions (Thyroid disease, Alzheimer's Disease, Insulin dependent diabetes, etc.)
Who cannot join
- Inadequate oral hygiene, bleeding on probing, pocket deeper than 3 mm mobility presence
- Sensitivity to percussion after root canal treatment
- Insufficient enamel tissue remaining in the relevant tooth
- Presence of radiographically abnormal periodontal space
- Teeth with inadequate bone support
- Teeth with root resorption and fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of 3D-Printed vs. Milled Endocrowns: A 2 Years Prospective Randomized Clinical Trial
The goal of this clinical trial is to examine the durability of endocrowns, created using various materials and manufacturing techniques with a fully digital workflow, and their ability to maintain functionality and aesthetics in the oral cavity.
The main questions it aims to answer were does effect of different materials on clinical success?
Read the detailed description
Based on the power analysis, it was determined that restorations would be applied to 11 teeth in each of the three material groups (lithium-disilicate reinforced glass-ceramic, polymer-infiltrated ceramic, and 3D-printed permanent hybrid resin). A total of 33 teeth received endocrown restorations.
The digital impressions of the patients receiving endocrown restorations were recorded using an intraoral optical scanner and sent to a specialised dental laboratory. For two of the groups (lithium disilicate-reinforced glass-ceramic, polymer-infiltrated ceramic), restorations were fabricated using block milling, while for the third group (permanent hybrid resin), restorations were produced through 3D printing. The restorations were cemented adhesively. The restorations were evaluated using the Modified FDI and Modified USPHS criteria at baseline (0) and at the 6-month follow-up, and the data were subjected to statistical analysis.
At the 6-month evaluation, no statistically significant difference in colour match was observed for any of the Modified USPHS criteria. All endocrowns produced with the three different materials survived and showed clinical success at the 6 and 24 months follow-up. Nevertheless, additional clinical studies with extended follow-up durations are required.
- Conditions
- Gross Material Loss in Endodontically Treated Upper and Lower Molars, No Systemic Infection, Gingival Steps Should be at Gum Level
- Being tested
- endocrowns
- Keywords
- endodontic treatment, CAD-CAM, endocrown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endocrownsOther
IPS Empress CAD Vita Enamic VarseoSmile Crown Plus
| Study group | Role | What they receive |
|---|---|---|
| Endocrown Materials | Experimental | IPS Empress CAD Vita Enamic VarseoSmile Crown Plus Receives: Other: endocrowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcomes
Restorations were checked clinically at the time of delivery and 6 months later. A 0.15 mm probe (DEPPELER 150EX, Rolle, Switzerland) was used for the controls.
Modified USPHS were used in the evaluations. The modified USPHS criteria were recorded as Alpha (A), Bravo (B), Charlie (C), Delta (D), and the modified FDI criteria were recorded as very good, good, adequate, unsatisfactory, and failed.
Marginal Discolouration, Marginal Integrity, Surface Texture, Wear, Postoperative Sensitivity and Recurrent Caries as Modified USPS Criteria were evaluated.
In the study, the headings of the result measurement tables will be created as follows:
Comparison of Baseline Modified USPHS Values According to Groups
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start15 May 2023
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gross Material Loss in Endodontically Treated Upper and Lower MolarsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulcan COSKUN AKAR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gulcan COSKUN AKAR, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850649
- Sponsor's protocol ID
- E-61749811-000-1963653
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2025
- Last updated
- 10 Aug 2026
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of 3D-Printed vs. Milled Endocrowns: A 2 Years Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06850649
- Acronym / sponsor ID
- E-61749811-000-1963653
- Conditions
- Gross Material Loss in Endodontically Treated Upper and Lower Molars, No Systemic Infection, Gingival Steps Should be at Gum Level
- Keywords
- endodontic treatment, CAD-CAM, endocrown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Gulcan COSKUN AKARUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 27 Feb 2025 (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 goal of this clinical trial is to examine the durability of endocrowns, created using various materials and manufacturing techniques with a fully digital workflow, and their ability to maintain functionality and aesthetics in the oral cavity.
The main questions it aims to answer were does effect of different materials on clinical success?
Detailed description
Based on the power analysis, it was determined that restorations would be applied to 11 teeth in each of the three material groups (lithium-disilicate reinforced glass-ceramic, polymer-infiltrated ceramic, and 3D-printed permanent hybrid resin). A total of 33 teeth received endocrown restorations.
The digital impressions of the patients receiving endocrown restorations were recorded using an intraoral optical scanner and sent to a specialised dental laboratory. For two of the groups (lithium disilicate-reinforced glass-ceramic, polymer-infiltrated ceramic), restorations were fabricated using block milling, while for the third group (permanent hybrid resin), restorations were produced through 3D printing. The restorations were cemented adhesively. The restorations were evaluated using the Modified FDI and Modified USPHS criteria at baseline (0) and at the 6-month follow-up, and the data were subjected to statistical analysis.
At the 6-month evaluation, no statistically significant difference in colour match was observed for any of the Modified USPHS criteria. All endocrowns produced with the three different materials survived and showed clinical success at the 6 and 24 months follow-up. Nevertheless, additional clinical studies with extended follow-up durations are required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endocrown Materials | Experimental | Other: endocrownsIPS Empress CAD Vita Enamic VarseoSmile Crown Plus |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must be a lower or upper molar tooth
- Must be periodontal healthy
- There must be at least two axial walls in the relevant tooth
- Gingival steps should be at gum level
- There must be neighboring teeth mesial and distal to the relevant tooth.
Key exclusion criteria (6 listed)
- Inadequate oral hygiene, bleeding on probing, pocket deeper than 3 mm mobility presence
- Sensitivity to percussion after root canal treatment
- Insufficient enamel tissue remaining in the relevant tooth
- Presence of radiographically abnormal periodontal space
- Teeth with inadequate bone support
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 |
|---|---|---|
| endocrownsIPS Empress CAD Vita Enamic VarseoSmile Crown Plus | Other | Endocrown Materials |
Primary outcome
Clinical Outcomes
Time frame: 24 month
Restorations were checked clinically at the time of delivery and 6 months later. A 0.15 mm probe (DEPPELER 150EX, Rolle, Switzerland) was used for the controls. Modified USPHS were used in the evaluations. The modified USPHS criteria were recorded as Alpha (A), Bravo (B), Charlie (C), Delta (D), and the modified FDI criteria were recorded as very good, good, adequate, unsatisfactory, and failed. Marginal Discolouration, Marginal Integrity, Surface Texture, Wear, Postoperative Sensitivity and Recurrent Caries as Modified USPS Criteria were evaluated. In the study, the headings of the result measurement tables will be created as follows: Comparison of Baseline Modified USPHS Values According to Groups
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 Aug 2026.
- Individual participant dataSharing planned: No
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 endocrowns in people with Gross Material Loss in Endodontically Treated Upper and Lower Molars and No Systemic Infection, run by Gulcan COSKUN AKAR at 1 site in Turkey (Türkiye).
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 Aug 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 Turkey (Türkiye). 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 Outcomes (time frame: 24 month). 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 Aug 2026.