Intraoral Imaging at Clinical Crown Lengthening
Primary Purpose
Dental Caries of Root Surface, Surgery
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CLP and 12 weeks waiting
Digital impression taken at surgery
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries of Root Surface focused on measuring Clinical crown lengthening, intraoral imaging, Emax crown
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.
Sites / Locations
- Advanced General Dentistry at UMB DS
- University of Maryland School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CLP and 12 weeks waiting
Digital impression taken at surgery
Arm Description
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.
The final impression will be taken at surgery. The final crown will be delivered at suture removal.
Outcomes
Primary Outcome Measures
Pocket Depth (the distance from the gingival margin to pocket base)
Changes in pocket depths at 6 months and 12 months from the baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT03064217
First Posted
February 17, 2017
Last Updated
February 1, 2022
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT03064217
Brief Title
Intraoral Imaging at Clinical Crown Lengthening
Official Title
The Use of Intraoral Imaging at Clinical Crown Lengthening Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 25, 2017 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries of Root Surface, Surgery
Keywords
Clinical crown lengthening, intraoral imaging, Emax crown
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLP and 12 weeks waiting
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Digital impression taken at surgery
Arm Type
Experimental
Arm Description
The final impression will be taken at surgery. The final crown will be delivered at suture removal.
Intervention Type
Procedure
Intervention Name(s)
CLP and 12 weeks waiting
Intervention Description
Restorative treatments will be initiated 12 weeks after clinical crown lengthenings (CLPs).
Intervention Type
Procedure
Intervention Name(s)
Digital impression taken at surgery
Intervention Description
The final impression will be made at surgery.
Primary Outcome Measure Information:
Title
Pocket Depth (the distance from the gingival margin to pocket base)
Description
Changes in pocket depths at 6 months and 12 months from the baseline
Time Frame
At baseline, 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se-Lim Oh, DMD
Organizational Affiliation
University of Maryland School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced General Dentistry at UMB DS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland School of Dentistry
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual patient data will not be shared. The results will be published.
Learn more about this trial
Intraoral Imaging at Clinical Crown Lengthening
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