NCT03064217

Intraoral Imaging at Clinical Crown Lengthening

The Use of Intraoral Imaging at Clinical Crown Lengthening Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries of Root Surface
• Surgery

Interventions

Type	Name	Description
DEVICE	Making impression at surgery	Making impression at surgery

Timeline

• Start date: 2017-05-25
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2017-02-24
• Last updated: 2025-02-07
• Results posted: 2025-02-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study