"Effect of Apical Patency on Post-endodontic Pain"

March 4, 2021 updated by: Yousaf, National University of Medical Sciences, Pakistan

"Effect Of Apical Patency On Post-Operative Pain After Single Visit Endodontic Treatment In Necrotic Teeth With Asymptomatic Apical Periodontitis: A Quasi Experimental Study"

This study is designed to find out the effect of maintaining apical patency versus non maintaining apical patency on post-operative pain after single visit endodontic treatment in necrotic teeth with asymptomatic apical periodontitis

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

After taking approval from the ethical committee (AFID No 905/Trg-ABP1K2), this study is planned at operative department in Armed Forces Institute of Dentistry, Rawalpindi from 01 June 2020 to 31 December 2020. Informed consent would be taken from 240 patients of 20-50 years of age from both gender with good general, mental and physical health who would be selected for this study and would be randomly divided into two equal groups with the help of scientific random number table.

The mandibular first molar teeth with asymptomatic apical periodontitis either with necrotic pulps, without any intra-oral or extra-oral swelling or any draining sinus tract will be selected for this study. Patients on preoperative analgesics and antibiotics, teeth with calcified canals and open apex, previously traumatized teeth and root canal treated teeth along with immune-compromised patients, pregnant and lactating mothers will be excluded from this study.

The patients reporting to the Operative Dentistry Department of Armed Forces Institute of Dentistry, Rawalpindi requiring root canals of their mandibular first molar will be screened for inclusion by taking history, performing relevant clinical examination and necessary investigations along with peri-apical radiographs. The whole procedure of the study will be explained to the patients in Urdu. After taking written informed consent from the willing participants of this study the procedure will be started. Two groups will be formed:

Group A: Patency group and Group B: Non-patency group Root canal treatment will be initiated under local anesthesia and rubber dam isolation. Working length will be taken with apex locator and will be confirmed with radiograph. The root canals will be instrumented with ProTaper Next system under copious irrigation with 5.25% sodium hypochlorite (NaOCl) and 17% EDTA solution.

In group A, a size 10 K file will be passed beyond the apical foramen between each instrument change to maintain apical patency while in group B, K file will be carried up to the working length only. A final peri-apical radiograph will be taken in the group A with the 10 K patency file 01mm beyond the apical foramen to confirm patency.

To control the microbiological impact on post-operative pain 2.5% sodium hypochlorite and 17% EDTA will be used as irrigants in both groups. Obturation will be done with cold lateral condensation using Pro Taper Next GP points and permanent restoration will be done with composite. At the end of this appointment patients will be given a visual analogue scale (VAS), and will be advised to mark at the scale according to his pain intensity after 24 hours and 48 hours after the treatment and will be asked to bring these reading with him on the next scheduled visit after one week for tooth preparation for metal ceramic crown. Patients will be given analgesic and will be advised to take it only in case of severe pain. VAS scores of less than 4 will be considered as no pain, score of 4-7 will be considered as mild and/or moderate pain and scores of 8 and above will be considered as severe pain. (no pain = <3, moderate pain = >4 to 7, severe pain = > 8). Frequencies, percentages, mean and standard deviation will be calculated for qualitative variable like inter appointment pain and for quantitative variables like gender; mean and standard deviation along with percentages in each group will be calculated with SPSS 22. Chi-square test will be used to compare the frequency of pain between the two groups after 24 and 48 hours of endodontic treatment. The p value of <0.05 will be considered significant.

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.
240

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46001
        • Afid, Nums

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Necrotic Mandibular first molar teeth with asymptomatic apical periodontitis
  • Mandibular first molar teeth without any intra-oral or extra-oral swelling or any draining sinus

Exclusion Criteria:

  • Patients on preoperative analgesics and antibiotics
  • Mandibular first molars with calcified canals and open apex
  • Previously traumatized teeth and root canal treated teeth
  • Immune-compromised patients
  • pregnant and lactating mothers

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Apical patency group
Patients in which apical patency is maintained.
Procedure: Maintaining apical patency
In apical patency group, a size 10 K file will be passed beyond the apical foramen between each instrument change to maintain apical patency while in Non apical patency group, K file will be carried up to the working length only. A final peri-apical radiograph will be taken in the group A with the 10 K patency file 01mm beyond the apical foramen to confirm patency.
No Intervention: Non- apical patency group
Patients in which apical patency is not maintained

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
Incidence of Post operative pain as determined by VAS (Visual Analogue Scale)
Time Frame: 06 months
To find out the incidence of post operative pain with Visual analogue scale after single visit endodontic treatment in necrotic teeth with asymptomatic apical periodontitis in two groups, Group A of 120 patients in which apical patency is maintained and Group B of 120 patients in which apical patency is non maintained. VAS (Visual Analogue Scale) will be used to measure pain. VAS scores of less than 4 will be considered as no pain, score of 4-7 will be considered as mild and/or moderate pain and scores of 8 and above will be considered as severe pain. (no pain = <3, moderate pain = >4 to 7, severe pain = > 8).
06 months

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.
National University of Medical Sciences, Pakistan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dil Rasheed, AFID

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.
June 1, 2020

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.
December 31, 2020

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.
December 31, 2020

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).
July 24, 2020

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 10, 2020

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 16, 2020

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 5, 2021

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, 2021

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, 2021

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.
  • 905/Trg-ABP1K2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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