Intraoral Imaging at Clinical Crown Lengthening

Surgery Clinical Trial

Official title:

The Use of Intraoral Imaging at Clinical Crown Lengthening Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064217
• Other study ID #: HP-00073913
• Status: Completed
• Phase: N/A
• Start date: May 25, 2017
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries of Root Surface
• Root Caries
• Surgery

Intervention

Procedure:
• CLP and 12 weeks waiting
Restorative treatments will be initiated 12 weeks after clinical crown lengthenings (CLPs).
• Digital impression taken at surgery
The final impression will be made at surgery.

Locations

Country	Name	City	State
United States	Advanced General Dentistry at UMB DS	Baltimore	Maryland
United States	University of Maryland School of Dentistry	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket Depth (the distance from the gingival margin to pocket base)	Changes in pocket depths at 6 months and 12 months from the baseline	At baseline, 6 months and 12 months