Dental ProsthesisNCT03146780
Digital vs Conventional Impressions Study
A study testing Conventional impression, Digital Scan 1 and Digital Scan 2 in people with Dental Prosthesis, run by University of Rochester at 1 site in United States.
Trial summary
This study aims to compare how a single cap best fit on a tooth that is fabricated with digital and conventional impression techniques. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Prosthesis
- What is being tested?
- Conventional impression, Digital Scan 1 and Digital Scan 2
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 1 Aug 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of patient ≥ 18 years old
- Good oral hygiene and compliance
- In need of a single full-coverage crown on any vital premolar or first molar tooth
- Opposing tooth is free of indirect restoration (crown)
- Asymptomatic tooth free of pathology
- No requirement for additional treatment (endodontic treatment, post and core, crown lengthening)
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- Anticipated supragingival or equigingival crown margin
- Anticipated crown margin on natural tooth structure
- Adequate abutment height after tooth preparation (minimum 4mm)
Who cannot join
- Age of patient less than 18 years old
- Poor oral hygiene and calculus on sample teeth
- In need of a single full-coverage crown on tooth other than a vital premolar or first molar tooth
- Opposing tooth is restored with indirect restoration
- Periapical or periodontal pathology
- Anticipated pulp exposure or need for additional treatment (endodontic treatment, post and core, crown lengthening)
Show all 9Show fewer
- Anticipated subgingival crown margin
- Anticipated crown margin on direct restoration
- Inadequate abutment height after tooth preparation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Digital Versus Conventional Impressions Part I: Marginal and Internal Fit
This study aims to compare how a single cap best fit on a tooth that is fabricated with digital and conventional impression techniques.
- Conditions
- Dental Prosthesis
- Being tested
- Conventional impression, Digital Scan 1, Digital Scan 2, Digital Scan 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional impressionProcedure or surgery
A dental impression is a negative imprint of hard (teeth) and soft tissues in the mouth from which a positive reproduction (or cast) can be form using alginate material. They are made by using a container which is designed to roughly fit over the dental arches ("trays").
Digital Scan 1Procedure or surgery
Direct intra-oral digital scans using Sirona Omnicam software.
Digital Scan 2Procedure or surgery
Direct intra-oral digital scans using Planmeca Planscan software.
Digital Scan 3Procedure or surgery
Direct intra-oral digital scans using 3M True Definition software.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Placebo comparator | Not described Receives: Procedure: Conventional impression |
| Digital 1 | Active comparator | Not described Receives: Procedure: Digital Scan 1 |
| Digital 2 | Active comparator | Not described Receives: Procedure: Digital Scan 2 |
| Digital 3 | Active comparator | Not described Receives: Procedure: Digital Scan 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a correctly fitted prosthesis
Correct fit assessed by clinical assessment of internal and marginal crown fit.
Measured: From impression stage to crown delivery, approximately four weeks. There are no follow up visits once crown is delivered.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start16 Oct 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ProsthesisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Chochlidakis, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146780
- Sponsor's protocol ID
- RSRB#00065524
- Status last verified
- Mar 2021
- First submitted
- 1 May 2017
- Last updated
- 17 Mar 2021
- 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 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Digital Versus Conventional Impressions Part I: Marginal and Internal Fit
- ClinicalTrials.gov ID
- NCT03146780
- Acronym / sponsor ID
- RSRB#00065524
- Conditions
- Dental Prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 10 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.
This study aims to compare how a single cap best fit on a tooth that is fabricated with digital and conventional impression techniques.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conventional | Placebo comparator | Procedure: Conventional impression |
| Digital 1 | Active comparator | Procedure: Digital Scan 1 |
| Digital 2 | Active comparator | Procedure: Digital Scan 2 |
| Digital 3 | Active comparator | Procedure: Digital Scan 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of patient ≥ 18 years old
- Good oral hygiene and compliance
- In need of a single full-coverage crown on any vital premolar or first molar tooth
- Opposing tooth is free of indirect restoration (crown)
- Asymptomatic tooth free of pathology
Key exclusion criteria (9 listed)
- Age of patient less than 18 years old
- Poor oral hygiene and calculus on sample teeth
- In need of a single full-coverage crown on tooth other than a vital premolar or first molar tooth
- Opposing tooth is restored with indirect restoration
- Periapical or periodontal pathology
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 |
|---|---|---|
| Conventional impressionA dental impression is a negative imprint of hard (teeth) and soft tissues in the mouth from which a positive reproduction (or cast) can be form using alginate material. They are made by using a container which is designed to roughly fit over the dental arches ("trays"). | Procedure or surgery | Conventional |
| Digital Scan 1Direct intra-oral digital scans using Sirona Omnicam software. | Procedure or surgery | Digital 1 |
| Digital Scan 2Direct intra-oral digital scans using Planmeca Planscan software. | Procedure or surgery | Digital 2 |
| Digital Scan 3Direct intra-oral digital scans using 3M True Definition software. | Procedure or surgery | Digital 3 |
Primary outcome
Number of participants with a correctly fitted prosthesis
Time frame: From impression stage to crown delivery, approximately four weeks. There are no follow up visits once crown is delivered.
Correct fit assessed by clinical assessment of internal and marginal crown fit.
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 17 Mar 2021.
- 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?
A study testing Conventional impression, Digital Scan 1 and Digital Scan 2 in people with Dental Prosthesis, run by University of Rochester 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 9 inclusion and 9 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 17 Mar 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. Some participants in this study may receive a placebo. 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?
Number of participants with a correctly fitted prosthesis (time frame: From impression stage to crown delivery, approximately four weeks. There are no follow up visits once crown is delivered.). 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 17 Mar 2021.