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Intraoral Imaging at Clinical Crown Lengthening

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ClinicalTrials.gov Identifier: NCT03064217
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Se-Lim Oh, University of Maryland Baltimore Dental School

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 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
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : July 30, 2020

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.




Primary Outcome Measures :
  1. Pocket Depth (the distance from the gingival margin to pocket base) [ Time Frame: At baseline, 6 months and 12 months ]
    Changes in pocket depths at 6 months and 12 months from the baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064217


Contacts
Contact: Se-Lim Oh, DMD 410-706-3708 soh@umaryland.edu
Contact: Debra Marshall 410-706-2940

Locations
United States, Maryland
Advanced General Dentistry at UMB DS Recruiting
Baltimore, Maryland, United States, 21201
Contact: Se-Lim Oh, DMD    410-706-3708      
Principal Investigator: Se-Lim Oh, DMD         
University of Maryland School of Dentistry Recruiting
Baltimore, Maryland, United States, 21201
Contact: Se-Lim Oh, DMD         
Sponsors and Collaborators
University of Maryland Baltimore Dental School
Investigators
Principal Investigator: Se-Lim Oh, DMD University of Maryland School of Dentistry

Responsible Party: Se-Lim Oh, Assistant Professor, University of Maryland Baltimore Dental School
ClinicalTrials.gov Identifier: NCT03064217     History of Changes
Other Study ID Numbers: HP-00073913
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data will not be shared. The results will be published.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Se-Lim Oh, University of Maryland Baltimore Dental School:
Clinical crown lengthening
intraoral imaging
Emax crown

Additional relevant MeSH terms:
Dental Caries
Root Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases