An interventional study of Making impression at surgery in Dental Caries of Root Surface and Surgery, sponsored by University of Maryland, Baltimore. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment
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.
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's enrollment of 20 is below the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Making impression at surgery
Device: Making impression at surgery
Making impression 8 weeks after surgery
Making impression at surgery
Pocket Depth
Changes in pocket depths (the distance from the gingival margin to pocket base) at 12 months from the baseline
Time frame: 12 months
| Milestone | Making Impression at Surgery | Making Impression 8 Weeks After Surgery |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
Changes in pocket depths (the distance from the gingival margin to pocket base) at 12 months from the baseline
| mm | Making Impression at Surgery | Making Impression 8 Weeks After Surgery |
|---|---|---|
| Pocket Depth | 2.7 ± 1.2 | 2.4 ± 1.0 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Making Impression at Surgery | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Making Impression 8 Weeks After Surgery | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Event | Making Impression at Surgery | Making Impression 8 Weeks After Surgery |
|---|---|---|
| PainNervous system disorders | 0/10 | 0/10 |
| Age, Categorical(Participants) | Making Impression at Surgery | Making Impression 8 Weeks After Surgery | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 9 | 14 |
| >=65 years | 5 | 1 | 6 |
| Age, Continuous(years) | Making Impression at Surgery | Making Impression 8 Weeks After Surgery | Total |
|---|---|---|---|
| Mean | 55.8 ± 22 | 45.5 ± 16.6 | 50.6 ± 19.7 |
| Sex: Female, Male(Participants) | Making Impression at Surgery | Making Impression 8 Weeks After Surgery | Total |
|---|---|---|---|
| Female | 6 | 8 | 14 |
| Male | 4 | 2 | 6 |
| Race and Ethnicity Not Collected(Participants) | Making Impression at Surgery | Making Impression 8 Weeks After Surgery | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Making Impression at Surgery | Making Impression 8 Weeks After Surgery | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
| Crestal bone loss(mm) | Making Impression at Surgery | Making Impression 8 Weeks After Surgery | Total |
|---|---|---|---|
| Mean | 1.78 ± 0.8 | 1.14 ± 0.7 | 1.6 ± 0.7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual patient data will not be shared. The results will be published.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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