Intraoral Imaging at Clinical Crown Lengthening

NCT ID: NCT03064217

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-25
• Study Completion Date: 2021-12-30

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.

Conditions

Dental Caries of Root Surface; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Making impression at surgery

Making impression at surgery

Group Type: EXPERIMENTAL

Making impression at surgery

Intervention Type: DEVICE

Making impression at surgery

Making impression 8 weeks after surgery

Making impression 8 weeks after surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Making impression at surgery

Making impression at surgery

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Se-Lim Oh

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Se-Lim Oh, DMD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland School of Dentistry

Locations

Advanced General Dentistry at UMB DS

Baltimore, Maryland, United States

University of Maryland School of Dentistry

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

HP-00073913

Identifier Type: -

Identifier Source: org_study_id