Deep Caries Lesion of Pemanent TeethAdjustment perNCT07051590
Adjustment Period for Partial Crowns
A study testing cad cam and 3D printer in people with Deep Caries Lesion of Pemanent Teeth, run by Ceren Sire at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the occlusal accuracy of CAD/CAM milled and 3D printed crowns guided by an occlusal device, starting from the same digital CAD design. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Deep Caries Lesion of Pemanent Teeth
- What is being tested?
- cad cam and 3D printer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2025to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Devitalized and vital teeth with tubercle loss
- ASA I
Who cannot join
- Teeth with periapical lesions
- Temporomandibular joint disorder or bruxism
- Periodontal disease
- Symptomatic vital teeth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ceren şire, araştırma görevlisi diş hekimi contact
About this study
Official title: Evaluation of the Time Required for Clinical Adaptation of Partial Dentures Based on Additive and Subtractive Manufacturing: A Randomized Controlled Clinical Study
The aim of this study is to compare the occlusal accuracy of CAD/CAM milled and 3D printed crowns guided by an occlusal device, starting from the same digital CAD design.
Read the detailed description
The subject of this study is to compare the occlusal closure performance of onlay restorations produced from CAD-CAM blocks and onlay restorations produced using 3D printer technology. The Occlusense device has the capacity to measure occlusal contact points and force distribution through digital pressure sensors, providing accurate data in clinical research.
This study is a randomized clinical trial conducted using a split-mouth design. Onlay restorations produced using different manufacturing methods will be applied to two teeth of the same patient, and the occlusal closures of both restorations will be evaluated.
- Conditions
- Deep Caries Lesion of Pemanent Teeth
- Being tested
- cad cam, 3D printer
- Keywords
- 3D, occlusense, partial crown, cad/cam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cad camDevice
Occlusion assessment in CAD CAM restorations
3D printerDevice
Crowns produced with 3D technology
| Study group | Role | What they receive |
|---|---|---|
| additive | Experimental | manufactured with 3D Receives: Device: 3D printer |
| subtractive | Experimental | manufactured with CAD/CAM Receives: Device: cad cam |
What is being measured
The primary outcome is the main question the study is designed to answer.
crown adjustment times
Using the occlusal relationships recorded with the occlusense recorder prior to the restoration preparation as a guide, the occlusal contacts will be adjusted at maximum intercuspation (ICM) and during protrusive and lateral excursive movements. The duration of these adjustments will be measured.
Measured: 1-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start20 Aug 2025 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Caries Lesion of Pemanent TeethStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subject of this study is to compare the occlusal closure performance of onlay restorations produced from CAD-CAM blocks with onlay restorations produced using 3D printer technology. The Occlusense device has the capacity to measure occlusal contact points and force distribution through digital pressure sensors, providing accurate data in clinical research. This study is a randomized clinical trial conducted using a split-mouth design. Onlay restorations produced using different manufacturing methods will be applied to two teeth of the same patient, and the occlusal closures of both restorations will
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceren Sire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ceren Sire, Cukurova University
- Investigators
- zeliha g bek kürklü, doçent, Study director, çukurova üniversitesi diş hekimliği restoratif diş tedavisiDoç. Dr. Dt, Study director, çukurova üniversitesi diş hekimliği restoratif diş tedavisi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051590
- Sponsor's protocol ID
- restorative dentistry
- Acronym
- Adjustment per
- Status last verified
- Jul 2025
- First submitted
- 3 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee WS, Lee DH, Lee KB. Evaluation of internal fit of interim crown fabricated with CAD/CAM milling and 3D printing system. J Adv Prosthodont. 2017 Aug;9(4):265-270. doi: 10.4047/jap.2017.9.4.265. Epub 2017 Aug 16.
PubMed 28874993
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Time Required for Clinical Adaptation of Partial Dentures Based on Additive and Subtractive Manufacturing: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07051590
- Acronym / sponsor ID
- Adjustment per / restorative dentistry
- Conditions
- Deep Caries Lesion of Pemanent Teeth
- Keywords
- 3D, occlusense, partial crown, cad/cam
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ceren SireUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 4 Jul 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 aim of this study is to compare the occlusal accuracy of CAD/CAM milled and 3D printed crowns guided by an occlusal device, starting from the same digital CAD design.
Detailed description
The subject of this study is to compare the occlusal closure performance of onlay restorations produced from CAD-CAM blocks and onlay restorations produced using 3D printer technology. The Occlusense device has the capacity to measure occlusal contact points and force distribution through digital pressure sensors, providing accurate data in clinical research.
This study is a randomized clinical trial conducted using a split-mouth design. Onlay restorations produced using different manufacturing methods will be applied to two teeth of the same patient, and the occlusal closures of both restorations will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The subject of this study is to compare the occlusal closure performance of onlay restorations produced from CAD-CAM blocks with onlay restorations produced using 3D printer technology. The Occlusense device has the capacity to measure occlusal contact points and force distribution through digital pressure sensors, providing accurate data in clinical research. This study is a randomized clinical trial conducted using a split-mouth design. Onlay restorations produced using different manufacturing methods will be applied to two teeth of the same patient, and the occlusal closures of both restorations will
| Arm | Type | Receives |
|---|---|---|
| additive | Experimental | Device: 3D printermanufactured with 3D |
| subtractive | Experimental | Device: cad cammanufactured with CAD/CAM |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Devitalized and vital teeth with tubercle loss
- ASA I
Key exclusion criteria (4 listed)
- Teeth with periapical lesions
- Temporomandibular joint disorder or bruxism
- Periodontal disease
- Symptomatic vital 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 |
|---|---|---|
| cad camOcclusion assessment in CAD CAM restorations | Device | subtractive |
| 3D printerCrowns produced with 3D technology | Device | additive |
Primary outcome
crown adjustment times
Time frame: 1-6 month
Using the occlusal relationships recorded with the occlusense recorder prior to the restoration preparation as a guide, the occlusal contacts will be adjusted at maximum intercuspation (ICM) and during protrusive and lateral excursive movements. The duration of these adjustments will be measured.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Results publication: PubMed 28874993Lee WS, Lee DH, Lee KB. Evaluation of internal fit of interim crown fabricated with CAD/CAM milling and 3D printing system. J Adv Prosthodont. 2017 Aug;9(4):265-270. doi: 10.4047/jap.2017.9.4.265. Epub 2017 Aug 16.
- Individual participant dataSharing planned: No
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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.
ceren şire, araştırma görevlisi diş hekimi contact
zeliha g bek kürklü, doçent study director
çukurova üniversitesi diş hekimliği restoratif diş tedavisi
Doç. Dr. Dt study director
çukurova üniversitesi diş hekimliği restoratif diş tedavisi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cad cam and 3D printer in people with Deep Caries Lesion of Pemanent Teeth, run by Ceren Sire 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 2 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: opening soon, as of the sponsor's last update on 4 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ceren şire, araştırma görevlisi diş hekimi (+905335103035 ext. 05335103035, cerensire98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
crown adjustment times (time frame: 1-6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07051590, which also lists 1 linked publication.
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 4 Jul 2025.