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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Making impression at surgery | Experimental | Making impression at surgery |
|
| Making impression 8 weeks after surgery | No Intervention | Making impression 8 weeks after surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Making impression at surgery | Device | Making impression at surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pocket Depth | Changes in pocket depths (the distance from the gingival margin to pocket base) at 12 months from the baseline | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Se-Lim Oh, DMD | University of Maryland School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced General Dentistry at UMB DS | Baltimore | Maryland | 21201 | United States | ||
| University of Maryland School of Dentistry |
Individual patient data will not be shared. The results will be published.
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| ID | Title | Description |
|---|---|---|
| FG000 | Making Impression at Surgery | Making impression at surgery Making impression at surgery: Making impression at surgery |
| FG001 | Making Impression 8 Weeks After Surgery | Making the final impression 8 weeks after surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Making Impression at Surgery | Making impression at surgery Making impression at surgery: Making impression at surgery |
| BG001 | Making Impression 8 Weeks After Surgery | Making the final impression 8 weeks after surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pocket Depth | Changes in pocket depths (the distance from the gingival margin to pocket base) at 12 months from the baseline | Posted | Mean | Standard Deviation | mm | 12 months |
|
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Making Impression at Surgery | Making impression at surgery Making impression at surgery: Making impression at surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Se-Lim Oh | University of Maryland, Baltimore | 4107063708 | soh@umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 11, 2022 | Jan 10, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D017213 | Root Caries |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Baltimore |
| Maryland |
| 21201 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Teeth |
|
| Participants |
| No |
| Participants |
|
|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Crestal bone loss | Mean | Standard Deviation | mm | Teeth |
|
|
| Participants |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Making Impression 8 Weeks After Surgery | Making the final impression 8 weeks after surgery | 0 | 10 | 0 | 10 | 0 | 10 |
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