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Gutta-percha Solvent on Postoperative Pain After Root Canal Retreatment

M

Mahidol University

Status

Completed

Conditions

Postoperative Pain
Root Canal
Retreatment

Treatments

Procedure: non-solvent
Procedure: solvent

Study type

Interventional

Funder types

Other

Identifiers

NCT04326998
MU-DT/PY-IRB 2019/054.2608

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

non-solvent
Active Comparator group
Description:
mechanical or heat treatment
Treatment:
Procedure: non-solvent
solvent
Experimental group
Description:
GuttaClear
Treatment:
Procedure: solvent

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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