Gutta-percha Solvent on Postoperative Pain After Root Canal Retreatment

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326998
• Other study ID #: MU-DT/PY-IRB 2019/054.2608
• Status: Completed
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: June 18, 2021

Study information

• Verified date: September 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 18, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Retreatment
• Root Canal

Intervention

Procedure:
• solvent
using solvent (GuttaClear) in procedure
• non-solvent
non-solvent

Locations

Country	Name	City	State
Thailand	Mahidoluniversity	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

Garcia-Font M, Durán-Sindreu F, Morelló 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 — View 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. — View 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. — View Citation

Topçuoglu HS, Topçuoglu 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: 10.1080/000163 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	NRS score recorded from 0 to 10 while 0 means no pain and 10 means the worst possible pain	3 days
Secondary	number of Ibuprofen intake		3 days