Effect of Apical Patency on Success of Root Canal Treatment in Non Vital Teeth

NCT03454815 | Completed DMC

• 1 other identifier: Mayank Arora Thesis
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

Maintaining Apical patency during root canal treatment is a widely followed methodology in modern endodontic treatment protocols. It involves passing of a small #08 or #10 K file through the apical foramen during root canal shaping without widening it. it is done to keep the foramen and apical thirds of root canal free of debris. proponents of the procedure claim it to improve irrigation; provide better tactile feedback; reduce the chances of procedural errors; reduce transportation and reduce pain following root canal procedures. however, there is no clinical trial which specifically evaluates the effect of apical patency on outcome of root canal procedure. hence this study was designed to evaluate the effect of apical patency on outcome of root canal treatment.

Conditions

Apical Periodontitis

Keywords

Apical Patency; Root Canal Treatment

Outcome Measures

Primary Outcomes (1)

• Change in periapical radiolucency

  The change observed in periapical radiolucency at the 12-month follow-up visit was used to assess the success of the treatment

  Baseline to 12-month

Secondary Outcomes (1)

• Clinical success

  Baseline to 12-month

Study Arms (2)

Patency Group

EXPERIMENTAL

apical patency was maintained during chemomechanical preparation

Procedure: Apical patency

Non Patency Group

NO INTERVENTION

Apical patency was not maintained during chemomechanical preparation

Interventions

Apical patency PROCEDURE

Apical patency was maintained by passing a #10 K file 1 mm beyond working length between every instrument change while doing chemomechanical preparation

Patency Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mature permanent mandibular first molars
• Diagnosis of pulp necrosis, as confirmed by negative response to cold and electrical tests
• Radiographic evidence of apical periodontitis (minimum size ≥ 2.0 × 2.0 mm)
• Probing depth \< 4mm

You may not qualify if:

• Non willingness to participate in study
• younger than 18 years of age
• Pregnant, diabetic or immunocompromised
• Prior endodontic treatment of the same tooth
• History of antibiotic use in past one month or requiring antibiotic pre-medication
• unrestorable teeth, fractured or perforated roots, grade 3 mobility

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 6, 2018
• Study Start: May 1, 2013
• Primary Completion: November 28, 2013
• Study Completion: November 30, 2014
• Last Updated: March 6, 2018

Record last verified: 2018-03