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Foraminal Enlargement and Postoperative Pain.

Primary Purpose

Pain Postoperative

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Foraminal enlargement

About this trial

This is an interventional treatment trial for Pain Postoperative focused on measuring Foraminal enlargement, Root canal treatment

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

In the control group, no foraminal enlargement will be performed.

Outcomes

Primary Outcome Measures

4-step pain intensity measures using a Visual Analog Scale (VAS).

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.

Secondary Outcome Measures

The number of patients taking an analgesic following the endodontics treatment.

The patients were asked to take an analgesic in the 7 days of time frame.

Full Information

NCT ID

NCT02770053

First Posted

May 11, 2016

Last Updated

October 28, 2016

Sponsor

Isparta Military Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02770053

Brief Title

Foraminal Enlargement and Postoperative Pain.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Isparta Military Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain Postoperative

Keywords

Foraminal enlargement, Root canal treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Active Comparator

Arm Description

In the control group, no foraminal enlargement will be performed.

Intervention Type

Procedure

Intervention Name(s)

Foraminal enlargement

Intervention Description

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.

Primary Outcome Measure Information:

Title

4-step pain intensity measures using a Visual Analog Scale (VAS).

Description

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.

Time Frame

7 days.

Secondary Outcome Measure Information:

Title

The number of patients taking an analgesic following the endodontics treatment.

Description

The patients were asked to take an analgesic in the 7 days of time frame.

Time Frame

7 days.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ibrahim E YAYLALI, Ph.D.

Organizational Affiliation

Isparta Military Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

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Foraminal Enlargement and Postoperative Pain.

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