Intraoral Imaging at Clinical Crown Lengthening

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Completed

CT.gov ID

NCT03064217

Collaborator

(none)

Enrollment

Locations

Arms

55.2

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries of Root Surface Surgery	Procedure: CLP and 12 weeks waiting Procedure: Digital impression taken at surgery	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Use of Intraoral Imaging at Clinical Crown Lengthening Procedures

Actual Study Start Date :

May 25, 2017

Actual Primary Completion Date :

Dec 30, 2021

Actual Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: CLP and 12 weeks waiting Restorative treatments will be initiated 12 weeks after clinical crown lengthenings (CLPs).
Experimental: Digital impression taken at surgery The final impression will be taken at surgery. The final crown will be delivered at suture removal.	Procedure: Digital impression taken at surgery The final impression will be made at surgery.

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: CLP and 12 weeks waiting

Restorative treatments will be initiated 12 weeks after clinical crown lengthenings (CLPs).

Experimental: Digital impression taken at surgery

The final impression will be taken at surgery. The final crown will be delivered at suture removal.

Procedure: Digital impression taken at surgery

The final impression will be made at surgery.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced General Dentistry at UMB DS	Baltimore	Maryland	United States	21201
2	University of Maryland School of Dentistry	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

University of Maryland, Baltimore

Investigators

Principal Investigator: Se-Lim Oh, DMD, University of Maryland School of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Se-Lim Oh, Assistant Professor, University of Maryland, Baltimore

ClinicalTrials.gov Identifier:

NCT03064217

Other Study ID Numbers:

HP-00073913

First Posted:

Feb 24, 2017

Last Update Posted:

Feb 3, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Se-Lim Oh, Assistant Professor, University of Maryland, Baltimore

Clinical crown lengthening

intraoral imaging

Emax crown

Additional relevant MeSH terms:

Dental Caries

Root Caries

Study Results

No Results Posted as of Feb 3, 2022