Clinical trial NCT04326998: Gutta-percha Solvent on Postoperative Pain After Root Canal Retreatment
Official title: Natural Gutta-percha Solvent Did Not Affect Postoperative Pain in Retreatment: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Root Canal
Retreatment
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: postoperative pain
timeFrame: 3 days
Secondary outcomes:
measure: number of Ibuprofen intake
timeFrame: 3 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Mahidoluniversity
Study officials:
affiliation: Mahidol University
name: Duangrat Sirijindamai, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Topcuoglu 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.
citation: Garcia-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.