Foraminal Enlargement and Postoperative Pain.

October 28, 2016 updated by: Ibrahim Ethem YAYLALI, Isparta Military Hospital

Influence of Foraminal Enlargement on Postoperative Pain in Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.

The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in teeth with necrotic pulp and apical periodontitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed. The investigators, therefore, would like to conduct a RCT to increase both sample size and the number of published studies to do a systematic review for this topic.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mature permenent teeth having pulpal 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Endodontic treatment will be performed in teeth with necrotic pulp and periapical periodontitis. Local anaesthesia will be provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation will be done.Using 2.5 % sodium hypochlorite, canal negotiation will be done. Foraminal enlargement will be achieved with #35 K-files in foraminal enlargement group after determining working length. Coronal flaring with # 2 and #3 Gates-Glidden drills will be done. The canals will be obturated with gutta-percha and epoxy resin sealer. The treatments will be carried out in single-visit.
Procedure: Foraminal enlargement
After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.
Active Comparator: Control
In the control group, no foraminal enlargement will be performed.
Procedure: Foraminal enlargement
After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4-step pain intensity measures using a Visual Analog Scale (VAS).
Time Frame: 7 days.
The severity of pain in 1-7 days according to the VAS: 0-3 mild pain, 4-7 moderate pain, and 8-10 severe pain.
7 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients taking an analgesic following the endodontics 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

January 1, 2016

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAH-2

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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