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Apical Patency and Postoperative Pain.

Primary Purpose

Pain Postoperative

Status
Completed
Phase
Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
APICAL PATENCY
Sponsored by
Isparta Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Postoperative focused on measuring apical patency, root canal treatment

Eligibility Criteria

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

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

Sites / Locations

  • Isparta Military Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

In the control group, apical patency did not maintained.

Outcomes

Primary Outcome Measures

100-mm Visual Analog Scale (VAS).
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).

Secondary Outcome Measures

The number of patients taking an analgesic following the endodontic treatment.
The patients were asked to take an analgesic in the 7 days of time frame.

Full Information

First Posted
May 5, 2016
Last Updated
October 23, 2017
Sponsor
Isparta Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02768285
Brief Title
Apical Patency and Postoperative Pain.
Official Title
Influence of Maintaining Apical Patency on Postoperative Pain in Posterior Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
July 17, 2017 (Actual)
Study Completion Date
August 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Isparta Military Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Postoperative
Keywords
apical patency, root canal treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
In the control group, apical patency did not maintained.
Intervention Type
Procedure
Intervention Name(s)
APICAL PATENCY
Intervention Description
After determining the working length, a small and flexible size 10 K-file was inserted 1 mm beyond the WL.
Primary Outcome Measure Information:
Title
100-mm Visual Analog Scale (VAS).
Description
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).
Time Frame
7 days.
Secondary Outcome Measure Information:
Title
The number of patients taking an analgesic following the endodontic 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
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Facility Information:
Facility Name
Isparta Military Hospital
City
Isparta
ZIP/Postal Code
32010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Apical Patency and Postoperative Pain.

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