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Gutta-percha Solvent on Postoperative Pain After Root Canal Retreatment

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT04326998
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
21
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: solvent
  • Procedure: non-solvent
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Natural Gutta-percha Solvent Did Not Affect Postoperative Pain in Retreatment: a Randomized Clinical Trial
Actual Study Start Date :
Sep 18, 2019
Actual Primary Completion Date :
Mar 18, 2021
Actual Study Completion Date :
Jun 18, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. postoperative pain [3 days]

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

Secondary Outcome Measures

  1. number of Ibuprofen intake [3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mahidoluniversity Bangkok Thailand 10400

Sponsors and Collaborators

  • Mahidol University

Investigators

  • Principal Investigator: Duangrat Sirijindamai, DDS, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahidol University
ClinicalTrials.gov Identifier:
NCT04326998
Other Study ID Numbers:
  • MU-DT/PY-IRB 2019/054.2608
First Posted:
Mar 30, 2020
Last Update Posted:
Sep 21, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pain, Postoperative

Study Results

No Results Posted as of Sep 21, 2021