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

March 4, 2018 updated by: Postgraduate Institute of Dental Sciences Rohtak

Effect of Apical Patency on Success of Primary Non-surgical Root Canal Treatment in Non Vital Teeth - a Prospective Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

AIM:

  1. To assess the role of maintaining Apical Patency on success of primary Non-Surgical Root Canal Treatment (NSRCT) in Non-Vital teeth.
  2. To evaluate the incidence of post-operative complications such as pain, flare-up etc with and without maintaining apical patency.

Study subjects were recruited from the pool of patients referred for the initial non-surgical root canal treatment to the post graduate department Of Conservative Dentistry & Endodontics at PGIDS, Rohtak (Haryana). Patients requiring Root Canal Treatment following the diagnosis pulpal necrosis in mature mandibular first molar were selected for the study.

Clinical procedure:

Subjects were randomly allocated to one of the two study groups (patency or non-patency). It was ensured that neither the patient, nor the primary investigator was aware of the treatment protocol before completing the consent process. After administration of local anesthesia, rubber dam isolation of the involved tooth was done. Caries excavation was done and access cavity prepared using carbide burs in high speed handpiece with copious irrigation. Debridement of the pulp chamber was done and all canal orifices identified. Working length was obtained with the help of electronic apex locator (Root ZX) and confirmed radiographically. ProTaper S1 and Sx were used to flare coronal thirds and WL was reconfirmed with apex locator. Hand files No. 10, 15 and 20 were used till working length (WL) to prepare a smooth reproducible glide path. ProTaper S1 and S2 were used till WL, followed by the use of ProTaper finishing files (F1/F2/F3) to prepare the canal to desired size as determined by the operator. Copious irrigation with 3% Sodium Hypochlorite was carried out throughout the procedure with the use of 27-gauge side vented needle.

In patency group, a #10 K- file was passed 1mm beyond the WL between each instrument change, while in non-patency group it was carried till the WL. In patency group, a final radiograph was taken after completion of preparation, with a #10 file placed 1mm beyond the WL to confirm patency.

After enlargement, the canals were irrigated with 5ml 17% EDTA for 1 min followed by irrigation with 5ml 3% NaOCl. Canals were dried with absorbent paper points and filled with a paste made by mixing Calcium hydroxide powder with 2% Chlorhexidine liquid; and the access cavity restored with intermediate restorative material (IRM). The patient was recalled after 1 week. At the next appointment, the paste was removed with H- files and copious irrigation with 3% NaOCl. Canals were examined under operating microscpe. A final rinse of 5ml 17% EDTA and 5ml 3% NaOCl was done and canals dried with paper points. Canals were obturated with the GuttaPercha and Zinc Oxide- Eugenol based sealer. After obturation, the cavity was restored with Silver Amalgam/Composite/Full coverage crown. Immediate post-operative radiograph was then taken using preset exposure parameters with Rinn paralleling device; and processed manually. Follow up clinical and radiographic examination was carried out every 3 months, till a 12 month period.

Data Gathering Details:

Preoperative and intraoperative data were obtained from patient records. Diagnostic and treatment information was meticulously recorded on a custom designed endodontic treatment form by the operator. Diagnostic and treatment details for each patient were extracted from the records by the principal investigator.

Assessment of treatment outcome:

Treatment outcome was judged on the basis of clinical and radiographic findings recorded at the follow up visit and comparison of the radiographs obtained at post obturation and the follow-up visit

Radiographic success:

Change in Periapical Index (PAI) scores (Orstaviket al) observed at 12-months was noted. Scoring of each tooth was done according to the following five point scale (PAI):

PAI Score Description of radiographic findings

  1. Normal periapical structures
  2. Small changes in bone structure
  3. Changes in bone structure with some mineral loss
  4. Periodontitis with well-defined radiolucent area
  5. Severe periodontitis with exacerbating features

Three experienced observers with no knowledge of the treatment protocol independently examined immediate post obturation and follow-up radiographs, mounted side by side, under controlled conditions. The treatment was considered successful only when both clinical and radiographic criteria were met. In multirooted teeth, the worst outcome by root decided the overall outcome for the tooth. In the event of disagreement, the three observers met to discuss their findings and came to an agreement. In the absence of unanimity, the majority decision was taken.

Clinical Success:

Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility of grade-I or less, and no deterioration in periodontal probing depth as compared with baseline measurements comprised the criteria for clinical success.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patency Group
apical patency was maintained during chemomechanical preparation
Procedure: Apical patency
Apical patency was maintained by passing a #10 K file 1 mm beyond working length between every instrument change while doing chemomechanical preparation
No Intervention: Non Patency Group
Apical patency was not maintained during chemomechanical preparation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in periapical radiolucency
Time Frame: Baseline to 12-month
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical success
Time Frame: Baseline to 12-month
Absence of pain and tenderness to percussion/palpation, the absence of sinus or any associated soft-tissue swelling, tooth mobility of grade 1 or less, and no deterioration in periodontal probing depth as compared with baseline measurements
Baseline to 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Postgraduate Institute of Dental Sciences Rohtak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Mayank Arora Thesis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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