Endocrown RestorationNCT03398395
Endocrown and 90° Shoulder Endocrown
A study testing endocrown restoration and 90° shoulder endocrown restoration in people with Endocrown Restoration, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Use chairside Computer-Aided Design \& Computer-Aided Manufacturing(CAD/CAM) system (computer aided design / manufacture), using glass ceramic zirconia enhanced lithium silicate glass ceramics (VITA, SUPRINITY, VS) material, compare the difference of firmness, comfort and durability between two kinds of root canal… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrown Restoration
- What is being tested?
- endocrown restoration and 90° shoulder endocrown restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to Jun 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-60 year old patients with healthy body, the tooth is molar, root tip no obvious damage, no root fracture by X-ray;
- after complete root canal therapy, the remaining 4 wall intact tooth tissue;
- after complete root canal therapy, the remaining 3 wall intact tooth tissue;
- have good oral hygiene habits;
- agreed to participate in the trial and signed the informed consent form;
- patients who are not participating in other clinical trials;
- after completion of the repair, compliance with the USPHS evaluation criteria of marginal density class A cases
Who cannot join
- obvious destruction of the apical tissue and large cysts;
- severe periodontitis patients;
- oral malignant tumor patients;
- radiotherapy patients;
- pregnant women;
- patients with mental illness or systemic diseases;
- people who can not take care of themselves;
- the researchers believe that is not suitable for the test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
NanFang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
WenJuan Yan, PHD, 15802018770, 645613053@qq.com
About this study
Official title: Comparison of Long Term Clinical Efficacy of Different Computer-Aided Design & Computer-Aided Manufacturing(CAD/CAM) Materials for the Restoration of Teeth With Root Canal Therapy With Endocrown or 90° Shoulder Endocrown
Use chairside Computer-Aided Design \& Computer-Aided Manufacturing(CAD/CAM) system (computer aided design / manufacture), using glass ceramic zirconia enhanced lithium silicate glass ceramics (VITA, SUPRINITY, VS) material, compare the difference of firmness, comfort and durability between two kinds of root canal restoration methods:endocrown and 90° shoulder endocrown. Objective to establish the optimal method and material for the restoration of the teeth with root canal therapy.
- Conditions
- Endocrown Restoration
- Being tested
- endocrown restoration, 90° shoulder endocrown restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endocrown restorationProcedure or surgery
a cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals.
90° shoulder endocrown restorationProcedure or surgery
a 90°cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals.
| Study group | Role | What they receive |
|---|---|---|
| endocrown restoration | Active comparator | a cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals. Receives: Procedure: endocrown restoration |
| 90° shoulder endocrown restoration | Active comparator | a 90°cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals. Receives: Procedure: 90° shoulder endocrown restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
USPHS criteria for dental restorations assessment
This criteria is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination. Some items are evaluated quantitatively, others visually.The score of all items is retained as the overall score of the restoration.
Measured: 2 Years
Secondary outcomes (3)
Marginal Adaptation
Clinical reevaluations were so far performed at baseline and 24 months after insertion according to modified United States Public Health Service (USPHS) criteria by 2 independent evaluators. A: Crown margin not discernible; probe does not catch; B: Probe catches on crown margin but no gap; gap or chipping on probing, with enamel exposed but polishable; C: Gap or chipping, with dentin or liner exposed ; D: Partial fracture, fracture, luxation.
Measured: 2 Years
Marginal discoloration
Clinical reevaluations were so far performed at baseline and 24 months after insertion according to modified United States Public Health Service (USPHS) criteria by 2 independent evaluators. A: No discoloration on the margin between the restoration and the tooth structure; B: Superficial discoloration on the margin between the restoration and the tooth structure; does not penetrate in pulpal direction; C: Discoloration has penetrated along the margin of the restorative material in pulpal direction.
Measured: 2 Years
Integrity of restoration
Clinical reevaluations were so far performed at baseline and 24 months after insertion according to modified United States Public Health Service (USPHS) criteria by 2 independent evaluators. A: Intact; B: Crack apparent on transillumination; C: Fracture observable; D: Crown lost(state at which interface debond occurred).
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Mar 2017
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (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 Endocrown RestorationStudies 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BuLing Wu, PHD, Study director, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398395
- Sponsor's protocol ID
- NFEC-2017-141
- Status last verified
- Apr 2022
- First submitted
- 28 Dec 2017
- Last updated
- 19 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sun J, Ruan W, He J, Lin X, Ci B, Yin S, Yan W. Clinical efficacy of different marginal forms of endocrowns: study protocol for a randomized controlled trial. Trials. 2019 Jul 24;20(1):454. doi: 10.1186/s13063-019-3530-1.
PubMed 31340845
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Long Term Clinical Efficacy of Different Computer-Aided Design & Computer-Aided Manufacturing(CAD/CAM) Materials for the Restoration of Teeth With Root Canal Therapy With Endocrown or 90° Shoulder Endocrown
- ClinicalTrials.gov ID
- NCT03398395
- Acronym / sponsor ID
- NFEC-2017-141
- Conditions
- Endocrown Restoration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 12 Jan 2018 (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.
Use chairside Computer-Aided Design \& Computer-Aided Manufacturing(CAD/CAM) system (computer aided design / manufacture), using glass ceramic zirconia enhanced lithium silicate glass ceramics (VITA, SUPRINITY, VS) material, compare the difference of firmness, comfort and durability between two kinds of root canal restoration methods:endocrown and 90° shoulder endocrown. Objective to establish the optimal method and material for the restoration of the teeth with root canal therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endocrown restoration | Active comparator | Procedure: endocrown restorationa cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals. |
| 90° shoulder endocrown restoration | Active comparator | Procedure: 90° shoulder endocrown restorationa 90°cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-60 year old patients with healthy body, the tooth is molar, root tip no obvious damage, no root fracture by X-ray;
- after complete root canal therapy, the remaining 4 wall intact tooth tissue;
- after complete root canal therapy, the remaining 3 wall intact tooth tissue;
- have good oral hygiene habits;
- agreed to participate in the trial and signed the informed consent form;
Key exclusion criteria (8 listed)
- obvious destruction of the apical tissue and large cysts;
- severe periodontitis patients;
- oral malignant tumor patients;
- radiotherapy patients;
- pregnant women;
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 |
|---|---|---|
| endocrown restorationa cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals. | Procedure or surgery | endocrown restoration |
| 90° shoulder endocrown restorationa 90°cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals. | Procedure or surgery | 90° shoulder endocrown restoration |
Primary outcome
USPHS criteria for dental restorations assessment
Time frame: 2 Years
This criteria is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination. Some items are evaluated quantitatively, others visually.The score of all items is retained as the overall score of the restoration.
3 secondary outcomes
Marginal Adaptation
Time frame: 2 Years
Marginal discoloration
Time frame: 2 Years
Integrity of restoration
Time frame: 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Derived from this study: PubMed 31340845Sun J, Ruan W, He J, Lin X, Ci B, Yin S, Yan W. Clinical efficacy of different marginal forms of endocrowns: study protocol for a randomized controlled trial. Trials. 2019 Jul 24;20(1):454. doi: 10.1186/s13063-019-3530-1.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
BuLing Wu, PHD study director
Nanfang Hospital, Southern Medical 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 endocrown restoration and 90° shoulder endocrown restoration in people with Endocrown Restoration, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 8 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: status not confirmed, as of the sponsor's last update on 19 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WenJuan Yan, PHD (15802018770, 645613053@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
USPHS criteria for dental restorations assessment (time frame: 2 Years). 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 NCT03398395, 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 19 Apr 2022.