Dental Caries of Root SurfaceNCT03064217
Intraoral Imaging at Clinical Crown Lengthening
A study testing Making impression at surgery in people with Dental Caries of Root Surface and Surgery, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
Crown lengthening surgery is done when a tooth needs to be fixed with a crown. Sometimes, not enough of the tooth sticks out above the gum to support a crown. This can happen when a tooth breaks off at the gum line, or when a crown or filling falls out of a tooth and there is decay underneath. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries of Root Surface, Surgery
- What is being tested?
- Making impression at surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 May 2017to 30 Dec 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >18 years
- a single-unsplinted crown needed
- the tooth must be in the area from the canine to the second molars
- a clinical crown lengthening is required to fabricate a crown
Who cannot join
- uncontrolled hypertension
- diabetes mellitus
- subjects with a history of a long-term use of corticosteroid (> 6 months)
- subjects with a history of taking oral/IV bisphosphonates within the past 2 years
- smokers.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Advanced General Dentistry at UMB DS
Baltimore, Maryland, 21201
University of Maryland School of Dentistry
Baltimore, Maryland, 21201
About this study
Official title: The Use of Intraoral Imaging at Clinical Crown Lengthening Procedures
Crown lengthening surgery is done when a tooth needs to be fixed with a crown. Sometimes, not enough of the tooth sticks out above the gum to support a crown. This can happen when a tooth breaks off at the gum line, or when a crown or filling falls out of a tooth and there is decay underneath. To place a crown, the dentist needs to expose more of the tooth. This is done by removing some gum tissue or bone.
After surgery, the area will heal in about three months. Then, making a crown can begin. This healing period often delays the delivery a final crown. This study is investing a way to make the final impression at the surgery to expedite the delivery of a final crown.
Read the detailed description
The purpose of this prospective study is to evaluate clinical and radiographic outcomes of single unsplinted fixed restorations made with digital intraoral imaging in conjunction with clinical crown lengthening procedures (CLPs) compared ones fabricated by the conventional protocol.
Specific Aim 1: To evaluate the clinical outcomes between the experimental group (the digital impression taking at clinical crown lengthening procedures) and the control group (the conventional protocol) Hypothesis: There will be no differences in clinical parameters around the teeth between the two groups.
Approach: The investigators will conduct a prospective clinical study and will compare the changes in gingival recession, the width of keratinized gingiva, and pocket depths around the teeth between the two groups.
Specific Aim 2: To evaluate the radiographic outcome between the experimental group and the control group Hypothesis: There will be no difference in crestal bone level around teeth between the two groups.
Approach: The study will investigate the difference in crestal bone level around the teeth at baseline and 12 months between the two groups.
- Conditions
- Dental Caries of Root Surface, Surgery
- Being tested
- Making impression at surgery
- Keywords
- Clinical crown lengthening, intraoral imaging, Emax crown
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Making impression at surgeryDevice
Making impression at surgery
| Study group | Role | What they receive |
|---|---|---|
| Making impression at surgery | Experimental | Making impression at surgery Receives: Device: Making impression at surgery |
| Making impression 8 weeks after surgery | No intervention | Making impression 8 weeks after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket Depth
Changes in pocket depths (the distance from the gingival margin to pocket base) at 12 months from the baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start25 May 2017
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
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 Dental Caries of Root SurfaceStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se-Lim Oh, University of Maryland, Baltimore
- Investigators
- Se-Lim Oh, DMD, Principal investigator, University of Maryland School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064217
- Sponsor's protocol ID
- HP-00073913
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2017
- Last updated
- 7 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual patient data will not be shared. The results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intraoral Imaging at Clinical Crown Lengthening Procedures
- ClinicalTrials.gov ID
- NCT03064217
- Acronym / sponsor ID
- HP-00073913
- Conditions
- Dental Caries of Root Surface, Surgery
- Keywords
- Clinical crown lengthening, intraoral imaging, Emax crown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 25 May 2017 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Posted 7 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Crown lengthening surgery is done when a tooth needs to be fixed with a crown. Sometimes, not enough of the tooth sticks out above the gum to support a crown. This can happen when a tooth breaks off at the gum line, or when a crown or filling falls out of a tooth and there is decay underneath. To place a crown, the dentist needs to expose more of the tooth. This is done by removing some gum tissue or bone.
After surgery, the area will heal in about three months. Then, making a crown can begin. This healing period often delays the delivery a final crown. This study is investing a way to make the final impression at the surgery to expedite the delivery of a final crown.
Detailed description
The purpose of this prospective study is to evaluate clinical and radiographic outcomes of single unsplinted fixed restorations made with digital intraoral imaging in conjunction with clinical crown lengthening procedures (CLPs) compared ones fabricated by the conventional protocol.
Specific Aim 1: To evaluate the clinical outcomes between the experimental group (the digital impression taking at clinical crown lengthening procedures) and the control group (the conventional protocol) Hypothesis: There will be no differences in clinical parameters around the teeth between the two groups.
Approach: The investigators will conduct a prospective clinical study and will compare the changes in gingival recession, the width of keratinized gingiva, and pocket depths around the teeth between the two groups.
Specific Aim 2: To evaluate the radiographic outcome between the experimental group and the control group Hypothesis: There will be no difference in crestal bone level around teeth between the two groups.
Approach: The study will investigate the difference in crestal bone level around the teeth at baseline and 12 months between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Making impression at surgery | Experimental | Device: Making impression at surgeryMaking impression at surgery |
| Making impression 8 weeks after surgery | No intervention | –Making impression 8 weeks after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >18 years
- a single-unsplinted crown needed
- the tooth must be in the area from the canine to the second molars
- a clinical crown lengthening is required to fabricate a crown
Key exclusion criteria (5 listed)
- uncontrolled hypertension
- diabetes mellitus
- subjects with a history of a long-term use of corticosteroid (> 6 months)
- subjects with a history of taking oral/IV bisphosphonates within the past 2 years
- smokers.
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 |
|---|---|---|
| Making impression at surgeryMaking impression at surgery | Device | Making impression at surgery |
Primary outcome
Pocket Depth
Time frame: 12 months
Changes in pocket depths (the distance from the gingival margin to pocket base) at 12 months from the baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual patient data will not be shared. The results will be published.
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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.
Se-Lim Oh, DMD principal investigator
University of Maryland School of Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Making impression at surgery in people with Dental Caries of Root Surface and Surgery, run by University of Maryland, Baltimore at 2 sites 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 4 inclusion and 5 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 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 7 Feb 2025). 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?
Pocket Depth (time frame: 12 months). 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 7 Feb 2025.