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Gutta-percha Solvent on Postoperative Pain After Root Canal Retreatment

Primary Purpose

Postoperative Pain, Root Canal, Retreatment

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
solvent
non-solvent
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

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

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

Sites / Locations

  • Mahidoluniversity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

non-solvent

solvent

Arm Description

mechanical or heat treatment

GuttaClear

Outcomes

Primary Outcome Measures

postoperative pain
NRS score recorded from 0 to 10 while 0 means no pain and 10 means the worst possible pain

Secondary Outcome Measures

number of Ibuprofen intake

Full Information

First Posted
March 27, 2020
Last Updated
September 14, 2021
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04326998
Brief Title
Gutta-percha Solvent on Postoperative Pain After Root Canal Retreatment
Official Title
Natural Gutta-percha Solvent Did Not Affect Postoperative Pain in Retreatment: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
March 18, 2021 (Actual)
Study Completion Date
June 18, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Root Canal, Retreatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non-solvent
Arm Type
Active Comparator
Arm Description
mechanical or heat treatment
Arm Title
solvent
Arm Type
Experimental
Arm Description
GuttaClear
Intervention Type
Procedure
Intervention Name(s)
solvent
Intervention Description
using solvent (GuttaClear) in procedure
Intervention Type
Procedure
Intervention Name(s)
non-solvent
Intervention Description
non-solvent
Primary Outcome Measure Information:
Title
postoperative pain
Description
NRS score recorded from 0 to 10 while 0 means no pain and 10 means the worst possible pain
Time Frame
3 days
Secondary Outcome Measure Information:
Title
number of Ibuprofen intake
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duangrat Sirijindamai, DDS
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahidoluniversity
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23382062
Citation
Jantarat J, Malhotra W, Sutimuntanakul S. Efficacy of grapefruit, tangerine, lime, and lemon oils as solvents for softening gutta-percha in root canal retreatment procedures. J Investig Clin Dent. 2013 Feb;4(1):60-3. doi: 10.1111/j.2041-1626.2012.00143.x.
Results Reference
result
PubMed Identifier
31093742
Citation
Genc Sen O, Erdemir A, Canakci BC. Effect of solvent use on postoperative pain in root canal retreatment: a randomized, controlled clinical trial. Clin Oral Investig. 2020 Jan;24(1):257-263. doi: 10.1007/s00784-019-02948-3. Epub 2019 May 15.
Results Reference
result
PubMed Identifier
28162017
Citation
Topcuoglu HS, Topcuoglu G. Postoperative pain after the removal of root canal filling material using different techniques in teeth with failed root canal therapy: a randomized clinical trial. Acta Odontol Scand. 2017 May;75(4):249-254. doi: 10.1080/00016357.2017.1283707. Epub 2017 Feb 5.
Results Reference
result
PubMed Identifier
29396645
Citation
Garcia-Font M, Duran-Sindreu F, Morello S, Irazusta S, Abella F, Roig M, Olivieri JG. Postoperative pain after removal of gutta-percha from root canals in endodontic retreatment using rotary or reciprocating instruments: a prospective clinical study. Clin Oral Investig. 2018 Sep;22(7):2623-2631. doi: 10.1007/s00784-018-2361-x. Epub 2018 Feb 2.
Results Reference
result

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Gutta-percha Solvent on Postoperative Pain After Root Canal Retreatment

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