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Completed

NCT Number: NCT04326998

Gutta-percha Solvent on Postoperative Pain After Root Canal Retreatment

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Retreatment Root Canal Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahidoluniversity

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

solvent

Procedure

using solvent (GuttaClear) in procedure

non-solvent

Procedure

non-solvent

Primary outcomes

  1. 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

Secondary outcomes

  1. number of Ibuprofen intake

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2020
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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