Apical Patency and Postoperative Pain.

October 23, 2017 updated by: Isparta Military Hospital

Influence of Maintaining Apical Patency on Postoperative Pain in Posterior Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.

The purpose of this study is to determine whether maintaining an apical patency causes postoperative pain in posterior teeth with necrotic pulp and apical periodontitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Apical patency (AP) is a procedure that prevents accumulation of soft and hard tissue debris within the cement canal. However, some RCTs indicate that maintaining an AP causes postoperative pain, whilst some RCTs pointed out there is no difference in terms of pain when AP has been performed. We, therefore, would like to conduct a RCT to increase the sample size of the previously performed RCTs to do an systematic review.

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Phase 1

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

  • Turkey
      • Isparta, Turkey, 32010
        • Isparta Military Hospital

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

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mature permanent teeth having plural necrosis and apical periodontitis

Exclusion Criteria:

  • Systemic disorders
  • Diabetes
  • Pregnancy
  • Less than 18 years of age
  • Immunocompromised
  • Patients who had taken antibiotics in the past 1 month
  • Patients who had a positive history of analgesic use within the past 3 days
  • Previously accessed teeth

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Endodontic treatment was performed in posterior teeth with necrotic pulp and periapical periodontitis using a reciprocating single-file system (Reciproc). Local anesthesia was provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation was done.Using 2.5 % sodium hypochlorite, canal negotiation was done & apical patency was achieved with #10 K-files in patency group after determining working length. Coronal flaring with # 2 and #3 Gates-Glidden drills was done. The canals were obturated with gutta-percha and epoxy resin sealer. The treatments were carried out in one-visit.
Procedure: APICAL PATENCY
After determining the working length, a small and flexible size 10 K-file was inserted 1 mm beyond the WL.
No Intervention: Control
In the control group, apical patency did not maintained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
100-mm Visual Analog Scale (VAS).
Time Frame: 7 days.
Pain severity was evaluated as no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm) and severe pain (75-100 mm).
7 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients taking an analgesic following the endodontic treatment.
Time Frame: 7 days.
The patients were asked to take an analgesic in the 7 days of time frame.
7 days.

Collaborators and Investigators

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

Sponsor

Isparta Military Hospital

Investigators

  • Principal Investigator: Ibrahim E YAYLALI, Ph.D., Isparta Military Hospital

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)

January 1, 2016

Primary Completion (Actual)

July 17, 2017

Study Completion (Actual)

August 7, 2017

Study Registration Dates

First Submitted

May 5, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAH-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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