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Foraminal Enlargement and Postoperative Pain.

NCT ID: NCT02770053

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Pain Postoperative

Keywords

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Foraminal enlargement Root canal treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Foraminal enlargement

Intervention Type PROCEDURE

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.

Control

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

Group Type ACTIVE_COMPARATOR

Foraminal enlargement

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isparta Military Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ibrahim Ethem YAYLALI

Head of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ibrahim E YAYLALI, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Isparta Military Hospital

Other Identifiers

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IAH-2

Identifier Type: -

Identifier Source: org_study_id