Gutta-percha Solvent on Postoperative Pain After Root Canal Retreatment
Natural Gutta-percha Solvent Did Not Affect Postoperative Pain in Retreatment: a Randomized Clinical Trial
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable postoperative-pain
Started Sep 2019
Typical duration for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2019
CompletedFirst Submitted
Initial submission to the registry
March 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2021
CompletedSeptember 21, 2021
September 1, 2021
1.5 years
March 27, 2020
September 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative pain
NRS score recorded from 0 to 10 while 0 means no pain and 10 means the worst possible pain
3 days
Secondary Outcomes (1)
number of Ibuprofen intake
3 days
Study Arms (2)
non-solvent
ACTIVE COMPARATORmechanical or heat treatment
solvent
EXPERIMENTALGuttaClear
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mahidoluniversity
Bangkok, 10400, Thailand
Related Publications (5)
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.
PMID: 23382062RESULTGenc 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.
PMID: 31093742RESULTTopcuoglu 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.
PMID: 28162017RESULTGarcia-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.
PMID: 29396645RESULTSirijindamai D, Wichai W, Mitrirattanakul S, Jantarat J. Effect of GuttaClear on Postoperative Pain After Root Canal Retreatment: A Randomized Clinical Trial. Eur Endod J. 2023 Jan;8(1):55-64. doi: 10.14744/eej.2022.85047.
PMID: 36748447DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Duangrat Sirijindamai, DDS
Mahidol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2020
First Posted
March 30, 2020
Study Start
September 18, 2019
Primary Completion
March 18, 2021
Study Completion
June 18, 2021
Last Updated
September 21, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share