The Effect of Instrumentation and Obturation on Postoperative Pain in Retreatment

NCT04789343 | Completed

• 1 other identifier: SAG-C-DUP-170419-0144
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontically Treated Teeth; Post Operative Pain

Keywords

post operative pain, retreatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post operative pain; change is being assessed.

  48 hours

Other Outcomes (2)

• Post operative pain; change is being assessed.

  72 hours.

• post operative pain; change is being assessed.

  7 days.

Study Arms (3)

hand files with lateral condensation technique

EXPERIMENTAL

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

Reciproc instrument with lateral condensation technique

EXPERIMENTAL

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

Reciporoc instrument with continuous warmed condensation technique

EXPERIMENTAL

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

Interventions

Root canal treatment OTHER

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.

Reciporoc instrument with continuous warmed condensation technique; Reciproc instrument with lateral condensation technique; hand files with lateral condensation technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Dentistry, Basibuyuk Campus, Maltepe

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth, Nonvital; Pain, Postoperative

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hesna Sazak Ovecoglu, DDS, PhD

  Marmara University Faculty of Dentistry Department of Endodontics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients asked one of three numbers (1-2-3) before treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 .

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 9, 2021
• Study Start: March 10, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 29, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Approximately 1 month later in www.tez.gov.tr
• Access Criteria: by the title of the study or the name of the researchers

Locations

TU (1)