Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment

May 22, 2018 updated by: Postgraduate Institute of Dental Sciences Rohtak

Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment: A Randomized Controlled Trial.

.There is no general agreement regarding the optimal concentration of sodium hypochlorite to be used in endodontic treatment.Therefore, this study aims to evaluate the effect of sodium hypochlorite concentration on the success of primary root canal treatment. The study population comprised of patients requiring primary root canal treatment following the diagnosis of pulpal necrosis with chronic apical periodontitis in mature mandibular first and second molars.Patients were randomly allocated in either High concentration or Low concentration group.

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

AIMS AND OBJECTIVES

  1. To evaluate the success of primary endodontic treatment following use of 5% and 1% NaOCl in non-vital, posterior teeth.
  2. To compare the success achieved following use of the two different concentrations of NaOCl.
  3. To evaluate postoperative pain following use of 5% and 1% NaOCl.

MATERIALS AND METHODS: Mature mandibular first and second molars with diagnosis of pulp necrosis (as confirmed by negative response to cold and electric pulp testing), and having apical radiolucency were chosen for the study.The consenting subjects were allocated to one of the two study groups based on concentration of NaOCl used: 5% [high concentration (HC)] and 1% [low concentration (LC)].Using an equal proportion randomization allocation ratio, envelopes containing concealed assignment codes were assigned sequentially to eligible patients.It was ensured that neither the patient, nor the primary investigator was aware of the treatment protocol before beginning of the treatment procedure.

CLINICAL PROCEDURE:

2% lidocaine with 1/80000 epinephrine was used to achieve profound local anaesthesia.

After proper isolation with rubber dam, access cavity was made with a high speed handpiece and carbide bur.

Debridement of the pulp chamber was done and all canal orifices were identified Lubricant (RC Prep) was placed at the entrance of the canal and canals negotiated with 10 no. K file.

Working length was established 1mm short of apical foramen by electronic apex loactor (Root ZX) and confirmed radiographically.

Root canal preparation was done by using rotary files according to manufacturer's instructions.

In both groups, 5ml of sodium hypochlorite was used as irrigant after each instrument change. All the irrigation procedures was performed using a 30 gauge needle. 5% and 1% NaOCl was used in HC and LC, respectively.

After root canal instrumentation, canals was irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 5% or 1% sodium hypochlorite, depending on the group.

Canals were dried with sterile absorbent paper points and filled with calcium hydroxide paste and the access cavity restored with Cavit.

The patients were recalled after 1 week. At the next appointment, the paste was removed with the use of Hedstroem files and copious irrigation with 5% or 1% sodium hypochlorite followed by 5ml 17% EDTA and a final rinse with 5ml 5% or 1% sodium hypochlorite.

Then, canals were obturated with the Gutta percha by lateral condensation technique and Zinc Oxide- Eugenol based sealer in both the groups.

After obturation, the cavity was restored permanently. Immediate post-operative radiograph was then be taken.

All the patients were prescribed Ibuprofen 400mg with the instructions to take only one tablet every 8 hours in the event of pain, if needed.Patients were asked to record the severity of pain using 10 cm VAS scale with 0 depicting no pain and 10 depicting maximum pain imaginable. Patients were asked to make a mark on the line that represented their level of perceived pain at 6 hr ,12 hr ,1 day,2 days,3 days,4 days,5 days,6 days and 7 days.One week later, patients returned with the completed questionnaires.

Follow up clinical and radiographic examination carried out every 3 months, till 12 month period.

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.
90

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 to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient willingness to participate in the study
  • Mature permanent mandibular first and second molars requiring primary root canal treatment
  • Diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber
  • Radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 mm)
  • Patient's age more than 18 years

Exclusion Criteria

  • Positive history of antibiotic use within past one month of the treatment.
  • Positive history of analgesic use within the past 3 days.
  • Patients who are pregnant, diabetic, immunocompromised, had serious medical illness or required antibiotic premedication
  • Patients with pockets ≥4mm or having marginal or furcal bone loss due to periodontitis
  • Teeth that are not suitable for rubber dam isolation
  • Previously accessed teeth and/or with procedural errors
  • Unrestorable tooth, fractured/ perforated roots, inflammatory root resorption

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: Double

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.
Active Comparator: Root canal treatment with 5% NaOCl
Root canal treatment with 5% NaOCl: 5 ml of 5% sodium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 5% sodium hypochlorite.
Procedure: Root canal treatment with 5% NaOCl
Other Names:
  • Endodontic treatment
Active Comparator: Root canal treatment with 1% NaOCl
5 ml of 1% soium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 1% sodium hypochlorite.
Procedure: Root canal treatment with 1% NaOCl
Other Names:
  • Endodontic treatment

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
Radiographic success
Time Frame: Every 3 months till 12 months
Treatment outcome was judged on the basis of radiographic findings recorded at the follow up visit and comparison of the radiographs obtained at post obturation and the follow-up visit.Change in Periapical Index (PAI) scores observed at 12-months was noted and scoring of each tooth was done according to the PAI scores and score less than 3 were considered as success.
Every 3 months till 12 months
Clinical success
Time Frame: Till 12 months
Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility, and no deterioration in periodontal probing depth as compared with baseline measurements comprised the criteria for clinical success.
Till 12 months

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
Pain intensity
Time Frame: Pain intensity recorded at different intervals (preoperatively, after 6 hours, 12 hours, 1day, 2 days, 3 days, 4days, 5 days, 6 days and 7 days).
Pain intensity before and after treatmemt was recorded by use of 10cm VAS with zero depicting no pain and 10 depicting maximum pain.Patient rate their pain intensity by making a mark somewhere on the line that represents their pain intensity and VAS was scored by measuring the distance from the "no pain" end of line.
Pain intensity recorded at different intervals (preoperatively, after 6 hours, 12 hours, 1day, 2 days, 3 days, 4days, 5 days, 6 days and 7 days).

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.
November 6, 2016

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 30, 2017

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, 2017

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).
September 11, 2017

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.
September 18, 2017

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.
September 20, 2017

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.
May 23, 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.
May 22, 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.
September 1, 2017

More Information

Terms related to this study

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.
  • Neha Verma

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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