LuxaCrownNCT03160950
Clinical Efficacy of Crowns Fabricated Using LuxaCrown
A study testing LuxaCrown in people with LuxaCrown and Single Crown Restoration, run by DMG Dental Material Gesellschaft mbH at 1 site in India.
Trial summary
A single arm non-blinded study is planned to evaluate the durability of the crowns fabricated using a novel composite based material, LuxaCrown (DMG, Germany). The durability of these crowns will be assessed for anatomical form, marginal adaptation, color match, marginal discoloration, surface roughness, secondary… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- LuxaCrown, Single Crown Restoration
- What is being tested?
- LuxaCrown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 19 Mar 2018to 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy adult patients with age range 25 - 60 years
- Only the patients who would be requiring Single crown restoration in the permanent anterior / posterior teeth will be selected for the purpose of study. Single crowns are usually indicated in either of the following conditions
- Extensive coronal / structural broken tooth due to caries or trauma
- Teeth undergone successful endodontic therapy (no signs of failure- asymptomatic, no tenderness on percussion, healthy associated soft tissue)
- Microdonts
- Teeth that require endodontic treatment shall be included in the study only after successful endodontic therapy has been completed by an experienced endodontist. The success of the endodontic therapy shall be evaluated using the standardized clinical and radiographic criteria by the endodontist.
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- Broken teeth with > ½ crown structure remaining will be selected.
- Broken teeth with < ½ crown structure remaining will also be selected provided they can be restored with a crown after a conventional Post and core.
- Patients with good Occlusal Contact will be selected.
- Patients who would be giving the Signed Informed Consent shall only be enrolled for the study.
- Only the teeth showing mobility grade 0 and 1 as per Miller's Criteria shall be selected for the purpose of study.
Who cannot join
- Patients showing signs of bruxism shall not be selected. History of bruxism and wear facets will be checked for ruling out the bruxism habit.
- Patients with severe periodontal disease, that involves all teeth or tooth indicated for crown fabrication shall not be included in the study.
- Any clinical or radiographic sig or symptom indicative of periapical or furcation involvement.
- If the tooth indicated for crown fabrication depicts a mobility grade 2 or 3 as per Miller's criteria, it shall be excluded from the study.
- History of any systemic illness, pregnancy or history of allergy to dental fillings/materials shall also be excluded.
- Teeth with fracture of crown en-masse (Ellis Class VIII) fracture or which are badly mutilated such that a very minimal or No coronal structure is remaining will be excluded.
- Hypoplastic / malformed teeth will not be selected for the purpose of study.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
DAV (C) Dental College Model Town
Yamuna Nagar, Haryana, 135001
Inder Kumar Pandit, Dr., +91 173220804 ext. 46, drpandit3080@gmail.com
Neeraj Gugnani, Dr., +91 173220804 ext. 46, drgugnani@gmail.com
About this study
Official title: Evaluating the Longevity and Safety of Full-coverage Crowns Fabricated With LuxaCrown Over a Period of 5 Years in 25-60 Year Old Indian Population: An Uncontrolled Trial
A single arm non-blinded study is planned to evaluate the durability of the crowns fabricated using a novel composite based material, LuxaCrown (DMG, Germany). The durability of these crowns will be assessed for anatomical form, marginal adaptation, color match, marginal discoloration, surface roughness, secondary caries, pulpal compatibility, plaque index and modified papillary bleeding index with intensive follow up for 2 years (at 1 week, 3rd, 6th, 12th, 18th and 24th month), and then a yearly follow-up for additional 3 years (at 36th, 48th and 60th month).
A total of 50 patients will be selected and one tooth per subject will be included. For the purpose of study only the healthy adult patients with age range of 25 - 60 years who would be requiring Single crown restoration in the permanent anterior / posterior teeth, either due to caries, pulpal involvement or trauma, will be selected. Teeth that require endodontic treatment shall be included in the study only after successful endodontic therapy has been completed by an experienced endodontist. For broken teeth, only the teeth with > 1/2 crown structure remaining or in case of teeth with <1/2 crown structure fractured that can be restored with conventional post and core will be selected. In general, patients with bruxism, or with severe periodontal disease, mobility grade 2 or 3 shall be excluded from the study.
- Conditions
- LuxaCrown, Single Crown Restoration
- Being tested
- LuxaCrown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuxaCrownDevice
Teeth that would be requiring RCT, would be initially treated by a endodontist using the standardized principles of rotary endodontics.
Restoration using the LuxaCrown as a direct composite crown: In short, the impression material will be loaded with the LuxaCrown material (DMG, Germany). Approx. 0:40 minutes after the start of mixing, the filled impression will be placed in the patient's mouth and will stay there for approx. 1:45 - 2:20 minutes, that is, till the material is partially set. The impression will then be taken out and the material will be allowed to set outside patient's mouth up to approximately 5 minutes after the start of mixing. The Crown will then be finished using a fine buff and pumice, followed by application of Glaze and Bond (DMG, Germany). The preparation will then be cleaned and slightly roughened with a bur or sand blaster at the adhesion sites. The crown fabricated will then be cemented using PermaCem 2.0 luting cement (DMG, Germany).
| Study group | Role | What they receive |
|---|---|---|
| LuxaCrown | Experimental | Not described Receives: Device: LuxaCrown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of anatomical form
Anatomical form will be assessed and scored according to Dijken modification of USPHS criteria.
Measured: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of marginal adaptation
Marginal adaptation will be assessed and scored according to Dijken modification of USPHS criteria.
Measured: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of color match
Color match will be assessed and scored according to Dijken modification of USPHS criteria.
Measured: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of marginal discoloration
Marginal discoloration will be assessed and scored according to Dijken modification of USPHS criteria.
Measured: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of surface roughness
Surface roughness will be assessed and scored according to Dijken modification of USPHS criteria.
Measured: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of secondary caries
Secondary caries will be assessed and scored according to Dijken modification of USPHS criteria.
Measured: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of wear
The severity of attrition will be scored as described by Pergamalian
Measured: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of pulpal compatibility
Assessment of the pulpal response by the FDI criteria
Measured: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of plaque index
Plaque index will be assessed and scored according to Sillness and Loe, 1964
Measured: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of modified papillary bleeding index
Measurement and scoring of modified papillary bleeding index (Barnett et al.)
Measured: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Secondary outcomes (1)
Change of patient satisfaction
Patient satisfaction will be assessed by FDI criteria.
Measured: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start19 Mar 2018
- Primary completionMar 2021 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LuxaCrownStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DMG Dental Material Gesellschaft mbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neeraj Gugnani, Dr., Principal investigator, Department of Pedodontics and Preventive Dentistry, DAV Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160950
- Sponsor's protocol ID
- DEPEND
- Status last verified
- Jul 2018
- First submitted
- 15 May 2017
- Last updated
- 16 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Longevity and Safety of Full-coverage Crowns Fabricated With LuxaCrown Over a Period of 5 Years in 25-60 Year Old Indian Population: An Uncontrolled Trial
- ClinicalTrials.gov ID
- NCT03160950
- Acronym / sponsor ID
- DEPEND
- Conditions
- LuxaCrown, Single Crown Restoration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- DMG Dental Material Gesellschaft mbHIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 19 May 2017 (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.
A single arm non-blinded study is planned to evaluate the durability of the crowns fabricated using a novel composite based material, LuxaCrown (DMG, Germany). The durability of these crowns will be assessed for anatomical form, marginal adaptation, color match, marginal discoloration, surface roughness, secondary caries, pulpal compatibility, plaque index and modified papillary bleeding index with intensive follow up for 2 years (at 1 week, 3rd, 6th, 12th, 18th and 24th month), and then a yearly follow-up for additional 3 years (at 36th, 48th and 60th month).
A total of 50 patients will be selected and one tooth per subject will be included. For the purpose of study only the healthy adult patients with age range of 25 - 60 years who would be requiring Single crown restoration in the permanent anterior / posterior teeth, either due to caries, pulpal involvement or trauma, will be selected. Teeth that require endodontic treatment shall be included in the study only after successful endodontic therapy has been completed by an experienced endodontist. For broken teeth, only the teeth with > 1/2 crown structure remaining or in case of teeth with <1/2 crown structure fractured that can be restored with conventional post and core will be selected. In general, patients with bruxism, or with severe periodontal disease, mobility grade 2 or 3 shall be excluded from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LuxaCrown | Experimental | Device: LuxaCrown |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy adult patients with age range 25 - 60 years
- Only the patients who would be requiring Single crown restoration in the permanent anterior / posterior teeth will be selected for the purpose of study. Single crowns are usually indicated in either of the following conditions
- Teeth that require endodontic treatment shall be included in the study only after successful endodontic therapy has been completed by an experienced endodontist. The success of the endodontic therapy shall be evaluated using the standardized clinical and radiographic criteria by the endodontist.
- Broken teeth with > ½ crown structure remaining will be selected.
- Broken teeth with < ½ crown structure remaining will also be selected provided they can be restored with a crown after a conventional Post and core.
Key exclusion criteria (7 listed)
- Patients showing signs of bruxism shall not be selected. History of bruxism and wear facets will be checked for ruling out the bruxism habit.
- Patients with severe periodontal disease, that involves all teeth or tooth indicated for crown fabrication shall not be included in the study.
- Any clinical or radiographic sig or symptom indicative of periapical or furcation involvement.
- If the tooth indicated for crown fabrication depicts a mobility grade 2 or 3 as per Miller's criteria, it shall be excluded from the study.
- History of any systemic illness, pregnancy or history of allergy to dental fillings/materials shall also be excluded.
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 |
|---|---|---|
| LuxaCrownTeeth that would be requiring RCT, would be initially treated by a endodontist using the standardized principles of rotary endodontics. Restoration using the LuxaCrown as a direct composite crown: In short, the impression material will be loaded with the LuxaCrown material (DMG, Germany). Approx. 0:40 minutes after the start of mixing, the filled impression will be placed in the patient's mouth and will stay there for approx. 1:45 - 2:20 minutes, that is, till the material is partially set. The impression will then be taken out and the material will be allowed to set outside patient's mouth up to approximately 5 minutes after the start of mixing. The Crown will then be finished using a fine buff and pumice, followed by application of Glaze and Bond (DMG, Germany). The preparation will then be cleaned and slightly roughened with a bur or sand blaster at the adhesion sites. The crown fabricated will then be cemented using PermaCem 2.0 luting cement (DMG, Germany). | Device | LuxaCrown |
Primary outcome
Change of anatomical form
Time frame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Anatomical form will be assessed and scored according to Dijken modification of USPHS criteria.
Change of marginal adaptation
Time frame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Marginal adaptation will be assessed and scored according to Dijken modification of USPHS criteria.
Change of color match
Time frame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Color match will be assessed and scored according to Dijken modification of USPHS criteria.
Change of marginal discoloration
Time frame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Marginal discoloration will be assessed and scored according to Dijken modification of USPHS criteria.
Change of surface roughness
Time frame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Surface roughness will be assessed and scored according to Dijken modification of USPHS criteria.
Change of secondary caries
Time frame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Secondary caries will be assessed and scored according to Dijken modification of USPHS criteria.
Change of wear
Time frame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
The severity of attrition will be scored as described by Pergamalian
Change of pulpal compatibility
Time frame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Assessment of the pulpal response by the FDI criteria
Change of plaque index
Time frame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Plaque index will be assessed and scored according to Sillness and Loe, 1964
Change of modified papillary bleeding index
Time frame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Measurement and scoring of modified papillary bleeding index (Barnett et al.)
1 secondary outcome
Change of patient satisfaction
Time frame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Individual participant dataSharing planned: Undecided
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.
Neeraj Gugnani, Dr. principal investigator
Department of Pedodontics and Preventive Dentistry, DAV Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LuxaCrown in people with LuxaCrown and Single Crown Restoration, run by DMG Dental Material Gesellschaft mbH at 1 site in India.
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 11 inclusion and 7 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 16 Jul 2018. 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 India. 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 Marcus Cebula, Dr. (00494084006 ext. 232, mcebula@dmg-dental.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of anatomical form (time frame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months). The study lists 10 primary outcomes in all. 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 16 Jul 2018.