Intraoral Imaging at Clinical Crown Lengthening
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03064217|
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : October 10, 2018
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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
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
|Contact: Se-Lim Oh, DMDemail@example.com|
|Contact: Debra Marshall||410-706-2940|
|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|
|Principal Investigator:||Se-Lim Oh, DMD||University of Maryland School of Dentistry|