Clinical trial NCT04197531: Postoperative Pain After the Use of Different Last Irrigation Method During Root Canal Treatment in Primary Teeth
Official title: A Comparative Evaluation of the Effect of EndoActivator and Endodontic Syringe Usage on Postoperative Pain in Root Canal Irrigations in Primary Molar Teeth: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Keywords: EndoActivator
Irrigation
Postoperative pain
Primary teeth
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 110
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was to evaluate and compare the postoperative pain levels after using EndoActivator and conventional endodontic syringe irrigation in root canal therapy of primary molars.


Eligibility criteria: Inclusion Criteria:

* Patients exhibiting positive or definitely positive behavior on the Frankl's behavior rating scale (rating 3 or 4 on the Frankl's scale)
* American Society of Anesthesiologists class 1 patients aged 5-9 years
* Patients with symptomatic irreversible pulpitis of maxillary primary molars confirmed using periapical radiographs, percussion, and cold test
* Patients having teeth with two-thirds of each root remaining
* Absence of periapical lesions and interradicular radiolucency
* Moderate to very severe (2-4) five-face scale pain scores in the 24-hour period before the procedure.

Exclusion Criteria:

* Patients who had taken analgesics and antibiotics within the last 12 hours before root canal treatment
* Teeth with pathologic root resorption
* Teeth with excessive mobility.

Primary outcomes:
measure: Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 8th hours
timeFrame: 8th hours
measure: Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 24th hours
timeFrame: 24th hours
measure: Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 48th hours
timeFrame: 48th hours
measure: Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 72th hours
timeFrame: 72th hours
Secondary outcomes:
measure: Analgesic intake comparison after root canal treatment with two different irrigation methods at 0-8 hours.
timeFrame: 0-8 hours
measure: Analgesic intake comparison after root canal treatment with two different irrigation methods at 8-24 hours.
timeFrame: 8-24 hours
measure: Analgesic intake comparison after root canal treatment with two different irrigation methods at 24-48 hours.
timeFrame: 24-48 hours
measure: Analgesic intake comparison after root canal treatment with two different irrigation methods at 48-72 hours.
timeFrame: 48-72 hours
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University, Faculty of Dentistry
Study officials:
affiliation: Erciyes University, Faculty of Dentistry
name: Hüsniye Gümüş, PHD., Dr.
role: STUDY_DIRECTOR
References:
citation: Ramamoorthi S, Nivedhitha MS, Divyanand MJ. Comparative evaluation of postoperative pain after using endodontic needle and EndoActivator during root canal irrigation: A randomised controlled trial. Aust Endod J. 2015 Aug;41(2):78-87. doi: 10.1111/aej.12076. Epub 2014 Sep 4.
citation: Yilmaz K, Tufenkci P, Adiguzel M. The effects of QMix and EndoActivator on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Clin Oral Investig. 2019 Nov;23(11):4173-4180. doi: 10.1007/s00784-019-02856-6. Epub 2019 Feb 27.
citation: Gumus H, Delikan E. The effect of sonic activation of irrigant on postoperative pain after root canal treatment in primary molar teeth: a randomized, clinical study. Clin Oral Investig. 2021 Jan;25(1):363-370. doi: 10.1007/s00784-020-03687-6. Epub 2020 Nov 12.