Single Edentulous SpaceNCT02218541
Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.
A study testing abutment margin 0.5 mm subgingival and abutment margin 1.5 mm subgingival in people with Single Edentulous Space, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The study will involve placing a dental implant through a guided surgery protocol developed using 3D CT technology. Because the implant position is planned digitally using the CT data from the patient, this allows investigation of an abutment that supports the implant crown and soft tissues to be fabricated prior to… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Single Edentulous Space
- What is being tested?
- abutment margin 0.5 mm subgingival and abutment margin 1.5 mm subgingival
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- partially edentulous with single edentulous space
- edentulous site where previous tooth has been extracted for at least two months
- minimum of 20 teeth present
- able to tolerate dental implant surgical and restorative procedures
- consent to participate in clinical trial
Who cannot join
- asa class 3+
- present drug use
- is pregnant or plans to become pregnant
- patients in need of lateral window sinus graft
- patients in need of grafting prior to implant placement
- patients in need of extensive grafting at time of implant placement
Show all 13Show fewer
- tooth is present or extracted within the last 2 months
- history of IV bisphosphonate use or oral bisphosphonate use contraindicating dental implant therapy
- untreated caries or periodontal disease
- severe bruxism
- smoker within past 6 months
- unlikely to be able to comply with study procedures according to investigators
- known allergy to any materials used in dental implant surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry
Chapel Hill, North Carolina, 27599
About this study
The study will involve placing a dental implant through a guided surgery protocol developed using 3D CT technology. Because the implant position is planned digitally using the CT data from the patient, this allows investigation of an abutment that supports the implant crown and soft tissues to be fabricated prior to implant placement. In doing so, this makes the protocol for patient care simpler and faster. In fabricating the the abutment prior to surgery, the investigators will design the abutments at different heights below the gumline to see an optimal margin height for fabrication of the abutment prior to surgery. The study hypothesis is that more often the abutment margin placed just slightly below (.5mm) the gumline will be visible about half of the time while the abutment margin placed further under the gumline (1.5mm) will be visible only about 10% of the time. The optimal outcome is that at delivery and follow-up, the abutment margin will not show intraorally.
- Conditions
- Single Edentulous Space
- Being tested
- abutment margin 0.5 mm subgingival, abutment margin 1.5 mm subgingival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abutment margin 0.5 mm subgingivalDevice
abutment margin 1.5 mm subgingivalDevice
| Study group | Role | What they receive |
|---|---|---|
| abutment margin 0.5 mm subgingival | Other | when fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline Receives: Device: abutment margin 0.5 mm subgingival |
| abutment margin 1.5 mm subgingival | Other | when fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline Receives: Device: abutment margin 1.5 mm subgingival |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Abutment Margin Exposure > 0
Margin exposure of the abutment between groups at 6 months post surgery.
Measured: up to 6 months post surgery
Secondary outcomes (2)
Number of Participants With a Soft Tissue Response of Bleeding
To assess the condition of the peri-implant mucosa, those with a soft tissue response of bleeding upon probing were counted. Fisher's exact test will be used after the site has been evaluated for presence of bleeding or not.
Measured: 6 months post surgery
Number of Participants With Provisional Crown Fit at Delivery
To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'
Measured: 8 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Single Edentulous SpaceStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingeborg De Kok, DDS, Principal investigator, University of North Carolina School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218541
- Sponsor's protocol ID
- 13-2376
- Status last verified
- May 2018
- First submitted
- 14 Aug 2014
- Last updated
- 27 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.
- ClinicalTrials.gov ID
- NCT02218541
- Acronym / sponsor ID
- 13-2376
- Conditions
- Single Edentulous Space
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Posted 27 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will involve placing a dental implant through a guided surgery protocol developed using 3D CT technology. Because the implant position is planned digitally using the CT data from the patient, this allows investigation of an abutment that supports the implant crown and soft tissues to be fabricated prior to implant placement. In doing so, this makes the protocol for patient care simpler and faster. In fabricating the the abutment prior to surgery, the investigators will design the abutments at different heights below the gumline to see an optimal margin height for fabrication of the abutment prior to surgery. The study hypothesis is that more often the abutment margin placed just slightly below (.5mm) the gumline will be visible about half of the time while the abutment margin placed further under the gumline (1.5mm) will be visible only about 10% of the time. The optimal outcome is that at delivery and follow-up, the abutment margin will not show intraorally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| abutment margin 0.5 mm subgingival | Other | Device: abutment margin 0.5 mm subgingivalwhen fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline |
| abutment margin 1.5 mm subgingival | Other | Device: abutment margin 1.5 mm subgingivalwhen fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- partially edentulous with single edentulous space
- edentulous site where previous tooth has been extracted for at least two months
- minimum of 20 teeth present
- able to tolerate dental implant surgical and restorative procedures
- consent to participate in clinical trial
Key exclusion criteria (13 listed)
- asa class 3+
- present drug use
- is pregnant or plans to become pregnant
- patients in need of lateral window sinus graft
- patients in need of grafting prior to implant placement
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 |
|---|---|---|
| abutment margin 0.5 mm subgingival | Device | abutment margin 0.5 mm subgingival |
| abutment margin 1.5 mm subgingival | Device | abutment margin 1.5 mm subgingival |
Primary outcome
Number of Participants With Abutment Margin Exposure > 0
Time frame: up to 6 months post surgery
Margin exposure of the abutment between groups at 6 months post surgery.
2 secondary outcomes
Number of Participants With a Soft Tissue Response of Bleeding
Time frame: 6 months post surgery
Number of Participants With Provisional Crown Fit at Delivery
Time frame: 8 weeks post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Ingeborg De Kok, DDS principal investigator
University of North Carolina School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abutment margin 0.5 mm subgingival and abutment margin 1.5 mm subgingival in people with Single Edentulous Space, run by University of North Carolina, Chapel Hill 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 5 inclusion and 13 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 27 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 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?
Yes. Results are posted in the registry (first posted 27 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Abutment Margin Exposure > 0 (time frame: up to 6 months post surgery). 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 27 Jul 2018.