Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Association of Endodontists | OTHER |
Not provided
Not provided
Not provided
Not provided
This study is looking into two different ways to perform a root canal treatment. The study will look at differences and compare the two different treatment options over a 2-year period.More specifically, this study evaluates a small "skinny" root canal shape compared to a larger "broad" root canal shape and if this affects the success of the root canal treatment. Both types of treatment are standard of care and aim to treat the infection inside your tooth. When a tooth is infected with bacteria, we can see a dark area on the radiograph around the roots of the infected tooth. If this dark area becomes smaller or goes away completely after root canal treatment and you do not feel any pain or other symptoms, then we know that the treatment was successful and there is no need for further treatment on this tooth. To measure the size of the dark area around the tooth (i.e. volume) before and after the treatment we will need to take two limited volume three-dimensional radiographs (cone beam computed tomography-CBCT), one prior to treatment and one at two years after the root canal treatment is completed. These radiographs are more accurate in detecting changes in lesion size than the regular periapical radiographs. We will assess the changes in lesion volume for all teeth included in the study and that will help us find differences in success between the two root canal treatment protocols, We are specifically looking for persons that have been diagnosed with a necrotic permanent mandibular molar with an evident radiographic lesion (i.e. dark area around the tooth) that can be retained in the mouth with root canal treatment and permanent restoration. This study place participants in different treatment groups after randomization. Randomization means that you are placed by chance (like flipping a coin) into a treatment group. For this study, there are two treatment groups (protocol) and they are listed below.
Protocol 1: Group S: Root canal treatment will be performed in 2-visits using hand files and rotary instruments to a final canal shape of size #25.
Protocol 2: Group L: Root canal treatment will be performed in 2-visits using hand files and rotary instruments to a final canal shape of size #35
We will perform a randomized, blinded clinical trial with clinical, microbiological and volumetric outcomes. The study population will be selected from adult patients in need of endodontic treatment on mandibular molars diagnosed with pulp necrosis and presenting with a visible radiographic lesion associated with at least the mesial root. Patients will be randomized into one of the two arms (group S: apical size#25; group L: apical size#35) and followed for 2 years post-treatment.
Treatment sequence Endodontic residents under the direct supervision of a study investigator will perform all treatments; all providers will be trained and calibrated for root canal treatment protocol and microbial sample collection. The calibration session will be repeated annually until completion of the study.
Treatment protocol First Appointment
1. Group S: Instrumentation technique to working length (WL) using the sequence 15/04 →20/04 →25/04 →25/06 Vortex Blue rotary file system (Dentsply).
2. Group L: Instrumentation technique to WL using the sequence 15/04 →20/04 →25/04 →25/06 → 30/04 →35/04 Vortex Blue rotary file system (Dentsply).
8. Distal(s) canal instrumentation will be standardized for both groups as follows:
1. Coronal 2/3 of distal canal will be instrumented with Vortex Blue rotary file 25/06 2. Apical instrumentation to WL using the sequence 15/04 →20/04 →25/04 →25/06 → 30/04 →35/04→40/04 Vortex Blue rotary file system (Dentsply) 9. The canals will be irrigated using a 30-gauge side-vented needle with 6% NaOCl (10ml/canal) followed by 17% ethylenediaminetetraacetic acid (EDTA; 5ml/canal) followed by a final rinse of 6% NaOCl (10ml/canal) and 5% sodium thiosulfate (2ml/canal).
10. A microbiological specimen (S2) will be obtained from mesial canals, and then the canals will be dried with paper points.
11. Calcium hydroxide [Ca(OH)2] will be placed as an interim intracanal medicament and a temporary restoration consisted of Fuji II LC (GC Corp, Tokyo, Japan) will be placed in the access. A post-op radiograph will be made.
Second appointment (within 10-14 days)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group S | Active Comparator | mesial canals in Group S will be instrumented to size 25 |
|
| Group L | Active Comparator | mesial canals in Group L will be instrumented to size 35 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| final apical size instrumentation | Procedure | root canal instrumentation to two different final preparation sizes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success of root canal therapy | Volumetric assessment of the periapical lesion between baseline and endpoint assessment | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between the number and taxa of bacteria remaining in the root canal at the time of obturation and treatment success between the two groups. | Culture-independent, molecular methods will be performed to quantify the total bacterial count before and after treatment in each group as well as identify the specific oral taxa in the root canal and their association to treatment success. | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vanessa Chrepa, DDS, MS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center | San Antonio | Texas | 78229 | United States | ||
| University of Washington Dental School |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
Not provided
Not provided
randomized clinical trial 2 arms
Not provided
Not provided
Similar instrumentation method is used for both groups, therefore participants cannot be aware of the allocation. Data will be de-identified prior to outcome assessment.
| Seattle |
| Washington |
| 98195 |
| United States |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |