Gutta-percha Solvent on Postoperative Pain After Root Canal Retreatment

September 14, 2021 updated by: Mahidol University

Natural Gutta-percha Solvent Did Not Affect Postoperative Pain in Retreatment: a Randomized Clinical Trial

The process of non-surgical retreatment includes removing the previous root canal filling materials, disinfecting and sealing the root canal system to prevent re-infection. Gutta-percha is the most common root canal filling material used with various types of sealers. To remove gutta-percha, solvent has been suggested because of its ability to dissolve gutta-percha. The new formula, under the brand name, GuttaClear, has been investigated for its comparable dissolving ability and lower cytotoxicity when compared with others that are currently used. However, no information is currently available of GuttaClear solvent concerning postoperative pain. Therefore, the present study will evaluate postoperative pain after non-surgical retreatment cases using GuttaClear as a solvent compared with no solvent used. Sixty participants are chosen and distributed into 2 groups, randomly. After the procedures, participants will receive the questionnaires about postoperative pain and the amount of medication intake. Both will be recorded at six time periods: (1) immediately after procedure; (2) 6 hours after procedure; (3) 12 hours after procedure; (4) 24 hours after procedure; (5) 48 hours after procedure and (6) 72 hours after procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Mahidoluniversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • not be contra-indicated with medication used in this study (ibuprofen)
  • have a previously treated endodontic single-root tooth with the need of retreatment
  • all those teeth must be restorable
  • old root canal filling materials must be located at 1 to 3 mm from the radiographic apex in the periapical radiograph

Exclusion Criteria:

  • open apex, root resorption or root perforation
  • participants presenting pre-operative pain and/or swelling at the appointment visit
  • taking analgesics or antibiotics less than one week before appointment visit
  • experiencing problems in completing the pain questionnaires
  • tooth which does not contain gutta-percha
  • cannot be patent through the apex at the appointment visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: non-solvent
mechanical or heat treatment
Procedure: non-solvent
non-solvent
Experimental: solvent
GuttaClear
Procedure: solvent
using solvent (GuttaClear) in procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: 3 days
NRS score recorded from 0 to 10 while 0 means no pain and 10 means the worst possible pain
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
number of Ibuprofen intake
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Duangrat Sirijindamai, DDS, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2019

Primary Completion (Actual)

March 18, 2021

Study Completion (Actual)

June 18, 2021

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-DT/PY-IRB 2019/054.2608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on non-solvent

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe