Clinical trial NCT03064217: Intraoral Imaging at Clinical Crown Lengthening
Official title: The Use of Intraoral Imaging at Clinical Crown Lengthening Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries of Root Surface
Surgery
Keywords: Clinical crown lengthening
intraoral imaging
Emax crown
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pocket Depth
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Advanced General Dentistry at UMB DS
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland School of Dentistry
state: Maryland
Study officials:
affiliation: University of Maryland School of Dentistry
name: Se-Lim Oh, DMD
role: PRINCIPAL_INVESTIGATOR
References: