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Intraoral Imaging at Clinical Crown Lengthening

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2017 by University of Maryland Baltimore Dental School
Sponsor:
Information provided by (Responsible Party):
Se-Lim Oh, University of Maryland Baltimore Dental School
ClinicalTrials.gov Identifier:
NCT03064217
First received: February 17, 2017
Last updated: February 21, 2017
Last verified: February 2017
  Purpose

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 Intervention
Dental Caries of Root Surface
Surgery
Procedure: CLP and 12 weeks waiting
Procedure: Digital impression taken at surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: The Use of Intraoral Imaging at Clinical Crown Lengthening Procedures

Further study details as provided by University of Maryland Baltimore Dental School:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 34
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: July 30, 2020
Estimated Primary Completion Date: April 30, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CLP and 12 weeks waiting
After core build-up and initial tooth preparation, a 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 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.

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 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 CLPs) 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 CLP 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland Baltimore Dental School
Investigators
Principal Investigator: Se-Lim Oh, DMD University of Maryland School of Dentistry
  More Information

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 
Study First Received: February 17, 2017
Last Updated: February 21, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: IPD 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 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

ClinicalTrials.gov processed this record on February 24, 2017