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Apical Patency and Postoperative Pain.

NCT ID: NCT02768285

Last Updated: 2017-10-25

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

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-08-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain Postoperative

Keywords

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apical patency root canal treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

APICAL PATENCY

Intervention Type PROCEDURE

After determining the working length, a small and flexible size 10 K-file was inserted 1 mm beyond the WL.

Control

In the control group, apical patency did not maintained.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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APICAL PATENCY

After determining the working length, a small and flexible size 10 K-file was inserted 1 mm beyond the WL.

Intervention Type PROCEDURE

Eligibility Criteria

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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
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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Responsibility Role SPONSOR

Principal Investigators

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Ibrahim E YAYLALI, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Isparta Military Hospital

Locations

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Isparta Military Hospital

Isparta, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IAH-1

Identifier Type: -

Identifier Source: org_study_id