Intraoral Imaging at Clinical Crown Lengthening

Study Overview
=================
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.

Official Title
-----------------
The Use of Intraoral Imaging at Clinical Crown Lengthening Procedures

Conditions
-----------------
Dental Caries of Root Surface, Surgery

Intervention / Treatment
-----------------
* Procedure: CLP and 12 weeks waiting
* Procedure: Digital impression taken at surgery


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pocket Depth (the distance from the gingival margin to pocket base) | Changes in pocket depths at 6 months and 12 months from the baseline | At baseline, 6 months and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical crown lengthening, intraoral imaging, Emax crown