Apical Size and Root Canal Treatment Success Trial (AS-RCT Trial)

NCT03053037 | Completed

• 1 other identifier: 51641
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Root Canal Therapy

Keywords

apical size; root canal treatment success; micro biome analysis; pulp necrosis

Outcome Measures

Primary Outcomes (1)

• Success of root canal therapy

  Volumetric assessment of the periapical lesion between baseline and endpoint assessment

  2 years

Secondary Outcomes (1)

• 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.

  2 years

Study Arms (2)

Group S

ACTIVE COMPARATOR

mesial canals in Group S will be instrumented to size 25

Procedure: final apical size instrumentation

Group L

ACTIVE COMPARATOR

mesial canals in Group L will be instrumented to size 35

Procedure: final apical size instrumentation

Interventions

final apical size instrumentation PROCEDURE

root canal instrumentation to two different final preparation sizes

Group L; Group S

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults 18-85 years old, ASA I, II
• Mandibular molars with diagnosis of necrotic pulp and periapical lesion associated with at least the mesial root
• Lesion with Periapical Index score \> 2 and largest lesion dimension \<10mm
• Fully developed apices and patent root canals, good periodontal health (probing depth \< 4mm)
• Confirmed restorability with crown restoration after root canal treatment or adequate existing full cuspal coverage restoration

You may not qualify if:

• ASA Class III or IV, immune-compromised patients, pregnant women, history of diabetes or bisphosphonate treatment
• Teeth with coronal cracks that extend below the CEJ, or with non-odontogenic periapical pathology and/or with not fully developed apices
• Molars with c-shape anatomy or middle medial canal
• Patients unable to present for a recall at one-year and/or two-year post-treatment or unwilling to participate

Sponsors & Collaborators

• University of Washington: lead
• American Association of Endodontists: collaborator

Study Sites (2)

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

University of Washington Dental School

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vanessa Chrepa, DDS, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: randomized clinical trial 2 arms

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: August 5, 2016
• Primary Completion: January 30, 2022
• Study Completion: February 7, 2022
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)