Dental Caries of Root Surface, Surgery
Conditions
Keywords
Clinical crown lengthening, intraoral imaging, Emax crown
Brief 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. 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.
Interventions
DEVICEMaking impression at surgery
Making impression at surgery
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pocket Depth | 12 months | Changes in pocket depths (the distance from the gingival margin to pocket base) at 12 months from the baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Making Impression at Surgery Making impression at surgery
Making impression at surgery: Making impression at surgery | 10 |
| Making Impression at Surgery Making impression at surgery
Making impression at surgery: Making impression at surgery | 10 |
| Making Impression 8 Weeks After Surgery Making the final impression 8 weeks after surgery | 10 |
| Making Impression 8 Weeks After Surgery Making the final impression 8 weeks after surgery | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Making Impression at Surgery | Making Impression 8 Weeks After Surgery | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 1 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 9 Participants | 14 Participants |
| Age, Continuous | 55.8 years STANDARD_DEVIATION 22 | 45.5 years STANDARD_DEVIATION 16.6 | 50.6 years STANDARD_DEVIATION 19.7 |
| Crestal bone loss | 1.78 mm STANDARD_DEVIATION 0.8 | 1.14 mm STANDARD_DEVIATION 0.7 | 1.6 mm STANDARD_DEVIATION 0.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Making Impression at Surgery | Pocket Depth | 2.7 mm | Standard Deviation 1.2 |
| Making Impression 8 Weeks After Surgery | Pocket Depth | 2.4 mm | Standard Deviation 1 |
p-value: <0.05t-test, 2 sided