Mouth, EdentulousNCT04023006
An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures Fabricated by AM
An observational study of Mouth, Edentulous, run by Dentsply International at 1 site in United States.
Trial summary
This observational clinical case series investigation will be conducted on approximately five (5) enrolled subjects at one (1) site in the US. Treatment of subjects encompasses all steps to fabricate new dentures for maxilla and/or mandible. The subjects will be followed 7-10 days after final delivery of the denture Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mouth, Edentulous
- What is being tested?
- Removable prostheses
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Apr 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigational device is part of a treatment concept for edentulous patients of all ages, gender and races. The incidence for tooth loss has not declined over years, and the prevalence for edentulism is significantly higher for adults 50 years and older. For this descriptive two-part survey, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) patients will be enrolled, i.e. 10 dentures will be fabricated within this study.
Who may be able to join
- Subject is 18 years or older.
- Subject has given written consent to participate in the trial.
- Subject is in good general health.
- Subject requires a new removable full denture for both jaws.
- Subject is completely edentulous in the maxilla and mandible.
- Subject is already wearing a full denture in the maxilla and mandible.
- Subject is willing to undergo dental treatment to receive a new full denture for both jaws.
- Subject confirms availability for treatment and all indicated follow-up visits.
Who cannot join
- Subject is younger than 18 years.
- Subject is pregnant.
- Subject has disabilities that do not allow a regular dental treatment.
- Subject with some systemic medical complications that cause difficulty in impression taking or judging occlusion of device.
- Subject is currently participating in another study.
- Subject has an allergic history regarding materials used in this trial.
Show all 20Show fewer
- Subject with xerostomia/ dry-mouth syndrome.
- Lack of compliance is expected.
- Those subjects who cannot provide informed consent for any reason
- Acute stomatitis.
- Status after tumor treatment in head-neck region (removal, radiotherapy).
- Acute cancer.
- Incomplete hard and/or soft tissue in the oral cavity.
- Muscle and/or nerve damage in the head-neck region.
- Insufficient vertical height and/or insufficient mouth opening.
- Resilient hyperplastic mucosa ("flappy ridges").
- Bruxism.
- Insufficient oral hygiene. The existing dentures should have no visible calculus.
- Previously enrolled in the present investigation.
- Involvement in the planning and conduct of the clinical investigation. (applies to all Dentsply Sirona \& Carbon 3D staff, investigational site staff staff and third party vendor).
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Goldman School of Dental MEdicine
Boston, Massachusetts, 02118
About this study
Official title: An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures
This observational clinical case series investigation will be conducted on approximately five (5) enrolled subjects at one (1) site in the US. Treatment of subjects encompasses all steps to fabricate new dentures for maxilla and/or mandible. The subjects will be followed 7-10 days after final delivery of the denture
Read the detailed description
This investigation is undertaken to evaluate the workflow and concomitant products to create full dentures by using additive manufacturing (AM) technology, i.e. Digital Light Processing™ Technology (Carbon 3D) to restore fully edentulous jaws. The assessment includes quality of materials provided by Dentsply Sirona Lab by using printers for AM (M series, Carbon 3D 1089 Mills Way, Redwood City, CA 94063). This assessment will be done by clinical review of the AM dentures on fit and quality. In addition, the evaluation includes a patient survey to assess current dentures and the new AM dentures with a subjective comparison of both.
The target subjects are male or female, 18 years and older with the need of a full denture in one or both jaws, being completely edentulous. The newly fabricated denture is to replace an existing full denture. For this descriptive study, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) and a maximum of ten (10) patients will be enrolled, i.e. ten to twenty (10-20) denture arches will be fabricated within this study.
- Conditions
- Mouth, Edentulous
- Being tested
- Removable prostheses
- Keywords
- Denture
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removable prosthesesDevice
Also called Lucitone 3D print resin dentures
Full dentures created by Additive manufacturing (Carbon Printers)
| Study group | Role | What they receive |
|---|---|---|
| Edentulous Patients | The investigational device is part of a treatment concept for edentulous patients of all ages, gender and races. The incidence for tooth loss has not declined over years, and the prevalence for edentulism is significantly higher for adults 50 years and older. For this descriptive two-part survey, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) patients will be enrolled, i.e. 10 dentures will be fabricated within this study. Receives: Device: Removable prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the fit of the denture
A questionnaire of assessment of fit by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1.
Much worse (5) Worse (4) Same (3) Better (2) Much better (1)
Measured: At Final Placement of Denture, through study completion, an average of one month
Secondary outcomes (3)
Aesthetics of dentures
A questionnaire of assessment of aesthetics by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1.
Much worse (5) Worse (4) Same (3) Better (2) Much better (1)
Measured: At Final Placement of Denture,through study completion, an average of one month
Function of dentures
A questionnaire of assessment of function by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1.
Much worse (5) Worse (4) Same (3) Better (2) Much better (1)
Measured: At Final Placement of Denture,through study completion, an average of 1 month
Dentist's satisfaction with treatment: questionnaire
A questionnaire of assessment of satisfactions of treatment by ranking, in comparison to the previous placed denture, using a Likert Scale from a minimum of 5 to a maximum of 1.
Much worse (5) Worse (4) Same (3) Better (2) Much better (1)
Measured: At Final Placement of Denture, through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Aug 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: No usable data were obtained. Therefore, the study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mouth, EdentulousStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023006
- Sponsor's protocol ID
- PRPA 22901 / CR 02
- Status last verified
- Feb 2021
- First submitted
- 12 Jul 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Celebic A, Knezovic-Zlataric D, Papic M, Carek V, Baucic I, Stipetic J. Factors related to patient satisfaction with complete denture therapy. J Gerontol A Biol Sci Med Sci. 2003 Oct;58(10):M948-53. doi: 10.1093/gerona/58.10.m948.
PubMed 14570864Schwindling FS, Bomicke W, Hassel AJ, Rammelsberg P, Stober T. Randomized clinical evaluation of a light-cured base material for complete dentures. Clin Oral Investig. 2014;18(5):1457-65. doi: 10.1007/s00784-013-1110-4. Epub 2013 Sep 21.
PubMed 24057919
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures
- ClinicalTrials.gov ID
- NCT04023006
- Acronym / sponsor ID
- PRPA 22901 / CR 02
- Conditions
- Mouth, Edentulous
- Keywords
- Denture
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No usable data were obtained. Therefore, the study was terminated.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dentsply InternationalIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 17 Jul 2019 (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.
This observational clinical case series investigation will be conducted on approximately five (5) enrolled subjects at one (1) site in the US. Treatment of subjects encompasses all steps to fabricate new dentures for maxilla and/or mandible. The subjects will be followed 7-10 days after final delivery of the denture
Detailed description
This investigation is undertaken to evaluate the workflow and concomitant products to create full dentures by using additive manufacturing (AM) technology, i.e. Digital Light Processing™ Technology (Carbon 3D) to restore fully edentulous jaws. The assessment includes quality of materials provided by Dentsply Sirona Lab by using printers for AM (M series, Carbon 3D 1089 Mills Way, Redwood City, CA 94063). This assessment will be done by clinical review of the AM dentures on fit and quality. In addition, the evaluation includes a patient survey to assess current dentures and the new AM dentures with a subjective comparison of both.
The target subjects are male or female, 18 years and older with the need of a full denture in one or both jaws, being completely edentulous. The newly fabricated denture is to replace an existing full denture. For this descriptive study, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) and a maximum of ten (10) patients will be enrolled, i.e. ten to twenty (10-20) denture arches will be fabricated within this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edentulous Patients | – | Device: Removable prosthesesThe investigational device is part of a treatment concept for edentulous patients of all ages, gender and races. The incidence for tooth loss has not declined over years, and the prevalence for edentulism is significantly higher for adults 50 years and older. For this descriptive two-part survey, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) patients will be enrolled, i.e. 10 dentures will be fabricated within this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigational device is part of a treatment concept for edentulous patients of all ages, gender and races. The incidence for tooth loss has not declined over years, and the prevalence for edentulism is significantly higher for adults 50 years and older. For this descriptive two-part survey, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) patients will be enrolled, i.e. 10 dentures will be fabricated within this study.
Key inclusion criteria (8 listed)
- Subject is 18 years or older.
- Subject has given written consent to participate in the trial.
- Subject is in good general health.
- Subject requires a new removable full denture for both jaws.
- Subject is completely edentulous in the maxilla and mandible.
Key exclusion criteria (20 listed)
- Subject is younger than 18 years.
- Subject is pregnant.
- Subject has disabilities that do not allow a regular dental treatment.
- Subject with some systemic medical complications that cause difficulty in impression taking or judging occlusion of device.
- Subject is currently participating in another study.
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 |
|---|---|---|
| Removable prosthesesAlso: Lucitone 3D print resin denturesFull dentures created by Additive manufacturing (Carbon Printers) | Device | Edentulous Patients |
Primary outcome
Assessment of the fit of the denture
Time frame: At Final Placement of Denture, through study completion, an average of one month
A questionnaire of assessment of fit by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1. Much worse (5) Worse (4) Same (3) Better (2) Much better (1)
3 secondary outcomes
Aesthetics of dentures
Time frame: At Final Placement of Denture,through study completion, an average of one month
Function of dentures
Time frame: At Final Placement of Denture,through study completion, an average of 1 month
Dentist's satisfaction with treatment: questionnaire
Time frame: At Final Placement of Denture, through study completion, an average of 1 month
Results and safety
The study was stopped early (reason given: No usable data were obtained. Therefore, the study was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background: PubMed 14570864Celebic A, Knezovic-Zlataric D, Papic M, Carek V, Baucic I, Stipetic J. Factors related to patient satisfaction with complete denture therapy. J Gerontol A Biol Sci Med Sci. 2003 Oct;58(10):M948-53. doi: 10.1093/gerona/58.10.m948.
- Background: PubMed 24057919Schwindling FS, Bomicke W, Hassel AJ, Rammelsberg P, Stober T. Randomized clinical evaluation of a light-cured base material for complete dentures. Clin Oral Investig. 2014;18(5):1457-65. doi: 10.1007/s00784-013-1110-4. Epub 2013 Sep 21.
- 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. 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?
An observational study of Mouth, Edentulous, run by Dentsply International at 1 site in United States.
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 8 inclusion and 20 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: stopped early, as of the sponsor's last update on 10 Feb 2021. 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 United States. 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 was stopped early (reason given: No usable data were obtained. Therefore, the study was terminated.). Results are not available in the source record.
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?
Assessment of the fit of the denture (time frame: At Final Placement of Denture, through study completion, an average of one 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 NCT04023006, which also lists 2 linked publications.
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 Feb 2021.