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The Effect of Instrumentation and Obturation on Postoperative Pain in Retreatment

Primary Purpose

Endodontically Treated Teeth, Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Root canal treatment
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring post operative pain, retreatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients who had previosly done unacceptable root canal treatment on lower premolar or molar with no pain.

No medication should be taken 10 days before treatment for any reason ( such as corticosteroid, antibiotics or analgesic )

Exclusion Criteria:

  • age less than 18 or over 65,pregnancy nonrestorable tooth other than lower molar or premolar tooth with more than 4mm periodontal pocket root with broken instrument or any post

Sites / Locations

  • Marmara University Faculty of Dentistry, Basibuyuk Campus, Maltepe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

hand files with lateral condensation technique

Reciproc instrument with lateral condensation technique

Reciporoc instrument with continuous warmed condensation technique

Arm Description

Previously done root canal filling removed by hand files (Hedstrom file,VDW, Munich,Germany ) and shaped with the same files and after instrumentation, all canals were filled by AH Plus sealer (Dentsply De Tray, Costanz, Germany) and lateral condensation technique of gutta-percha.

Previous root canal filling removed by Reciproc instrument (VDW ,Munich, Germany )using Endomotor (VDW, Munich, Germany). After removal, root canal instrumented with the same instrument and obturated using AHPlus sealer with lateral condensation technique of gutta-percha.

Previous root canal removed by Reciproc instrument using Endomotor, shaped and obturated by AhPlus sealer with continuous gutta-percha technique (Diadent Dia-Duo (Diadent, Chongju, Korea).

Outcomes

Primary Outcome Measures

Post operative pain
VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic

Secondary Outcome Measures

Post operative pain; change is being assessed.
VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic

Full Information

First Posted
February 23, 2021
Last Updated
March 4, 2021
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04789343
Brief Title
The Effect of Instrumentation and Obturation on Postoperative Pain in Retreatment
Official Title
The Effect of Reciprocating Instrument and Obturation Techniques on Postoperative Pain in Retreatment : A Prospective Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objectives: The aim of this study was to assess postoperative pain in prospective randomized clinical trial comparing Reciproc or hand instrument and also different obturation techniques in one visit of endodontic retreatment. Conventional root canal treatment was done to 45 patients who needed retreatment. All instruments used in this study are routinely used instrument in endodontic therapy. After completed root canal treatment, the patients asked the intense of post operative pain.
Detailed Description
Materials and metods: The study was included 45 patients (18-65 yrs old) who needed endodontic retreatment in mandibular premolar or molar without any symptoms. The teeth had been randomly assign into 3 groups according to the instrumentation or obturation techniques; hand files with lateral condensation, Reciproc with lateral condensation, or Reciproc with continuous condensation technique. Retreatments had performed in a single visit. Coronal restorations were removed, the gutta-percha were extracted using either Reciproc or hand files. After, biochemical and mechanical praparation, the canals were filled with gutta-percha cones and AH Plus sealer using the lateral condensation or continuous wave of obturation technique. Participants were been asked to rate the incidence and intensity of the postoperative pain on a verbal rating scale 24h, 48h and 72h and 7 days after retreatment. All data were analyzed using (Chi-square test, p=0,05)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth, Post Operative Pain
Keywords
post operative pain, retreatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Conventional root canal treatment was perfomed to 45 patients who had been done unacceptable root canal treatment (such as short root canal filling ) on lower premolar or molar teeth before. The patents were healthy and did not take any antibiotics or any medication .
Masking
Participant
Masking Description
The patients asked one of three numbers (1-2-3) before treatment.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hand files with lateral condensation technique
Arm Type
Experimental
Arm Description
Previously done root canal filling removed by hand files (Hedstrom file,VDW, Munich,Germany ) and shaped with the same files and after instrumentation, all canals were filled by AH Plus sealer (Dentsply De Tray, Costanz, Germany) and lateral condensation technique of gutta-percha.
Arm Title
Reciproc instrument with lateral condensation technique
Arm Type
Experimental
Arm Description
Previous root canal filling removed by Reciproc instrument (VDW ,Munich, Germany )using Endomotor (VDW, Munich, Germany). After removal, root canal instrumented with the same instrument and obturated using AHPlus sealer with lateral condensation technique of gutta-percha.
Arm Title
Reciporoc instrument with continuous warmed condensation technique
Arm Type
Experimental
Arm Description
Previous root canal removed by Reciproc instrument using Endomotor, shaped and obturated by AhPlus sealer with continuous gutta-percha technique (Diadent Dia-Duo (Diadent, Chongju, Korea).
Intervention Type
Other
Intervention Name(s)
Root canal treatment
Intervention Description
The patient usually takes anaesthesia before treatment and access cavity was prepared on the tooth and root canal removed and instrumented and obturated. However, in the present study, previously done root canal was retreated. Usually no anaesthesia was used because all root canals were done before. So just instrumentation and obturation was done.
Primary Outcome Measure Information:
Title
Post operative pain
Description
VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic
Time Frame
24 hours.
Secondary Outcome Measure Information:
Title
Post operative pain; change is being assessed.
Description
VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
Post operative pain; change is being assessed.
Description
VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic
Time Frame
72 hours.
Title
post operative pain; change is being assessed.
Description
VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic
Time Frame
7 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients who had previosly done unacceptable root canal treatment on lower premolar or molar with no pain. No medication should be taken 10 days before treatment for any reason ( such as corticosteroid, antibiotics or analgesic ) Exclusion Criteria: age less than 18 or over 65,pregnancy nonrestorable tooth other than lower molar or premolar tooth with more than 4mm periodontal pocket root with broken instrument or any post
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hesna Sazak Ovecoglu, DDS, PhD
Organizational Affiliation
Marmara University Faculty of Dentistry Department of Endodontics
Official's Role
Study Chair
Facility Information:
Facility Name
Marmara University Faculty of Dentistry, Basibuyuk Campus, Maltepe
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All statistical datas was documented in post doctorate thesis and will be available at www.tez.gov.tr in a month. Also will be send for publication in one of the dental journal.
IPD Sharing Time Frame
Approximately 1 month later in www.tez.gov.tr
IPD Sharing Access Criteria
by the title of the study or the name of the researchers

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The Effect of Instrumentation and Obturation on Postoperative Pain in Retreatment

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