The Effect of Instrumentation and Obturation on Postoperative Pain in Retreatment

The Effect of Reciprocating Instrument and Obturation Techniques on Postoperative Pain in Retreatment : A Prospective Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain; Endodontically Treated Teeth
• Intervention / Treatment: Other: Root canal treatment

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)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34854
    • Marmara University Faculty of Dentistry, Basibuyuk Campus, Maltepe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hand files with lateral condensation technique; 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.	Other: Root canal treatment; 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.
Experimental: Reciproc instrument with lateral condensation technique; 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.	Other: Root canal treatment; 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.
Experimental: Reciporoc instrument with continuous warmed condensation technique; 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).	Other: Root canal treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	72 hours.
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	7 days.

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Chair: Hesna Sazak Ovecoglu, DDS, PhD, Marmara University Faculty of Dentistry Department of Endodontics

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): December 29, 2020

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: post operative pain, retreatment
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Tooth, Nonvital
• Other Study ID Numbers: SAG-C-DUP-170419-0144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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