Intraoral Imaging At Clinical Crown Lengthening

Not Applicable

Completed

• Conditions: Dental Caries of Root Surface; Surgery
• Interventions: Procedure: CLP and 12 weeks waiting; Procedure: Digital impression taken at surgery

• Registration Number: NCT03064217
• Lead Sponsor: University of Maryland, Baltimore

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Study Start: 2017-05-25
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLP and 12 weeks waiting	CLP and 12 weeks waiting	After core build-up and initial tooth preparation, a clinical crown lengthening procedure (CLP) will be performed. Restorative treatments will be initiated 12 weeks after CLPs.
Digital impression taken at surgery	Digital impression taken at surgery	The final impression will be taken at surgery. The final crown will be delivered at suture removal.

Primary Outcome Measures

Name	Time	Method
Pocket Depth (the distance from the gingival margin to pocket base)	At baseline, 6 months and 12 months	Changes in pocket depths at 6 months and 12 months from the baseline

Trial Locations

Locations (2)

Advanced General Dentistry at UMB DS; 🇺🇸 Baltimore, Maryland, United States

University of Maryland School of Dentistry; 🇺🇸 Baltimore, Maryland, United States