Postoperative Pain After the Use of Different Last Irrigation Method During Root Canal Treatment in Primary Teeth

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04197531
• Other study ID #: 2018/152
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: December 2019
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 30, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Other:
• Irrigation Method
Irrigation Method

Locations

Country	Name	City	State
Turkey	Erciyes University, Faculty of Dentistry	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Yilmaz K, Tüfenkçi P, Adigüzel 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 8th hours	Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.	8th hours
Primary	Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 24th hours	Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.	24th hours
Primary	Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 48th hours	Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.	48th hours
Primary	Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 72th hours	Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.	72th hours
Secondary	Analgesic intake comparison after root canal treatment with two different irrigation methods at 0-8 hours.	The patients were asked to choose one of the two options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep".	0-8 hours
Secondary	Analgesic intake comparison after root canal treatment with two different irrigation methods at 8-24 hours.	The patients were asked to choose one of the two options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep".	8-24 hours
Secondary	Analgesic intake comparison after root canal treatment with two different irrigation methods at 24-48 hours.	The patients were asked to choose one of the two options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep".	24-48 hours
Secondary	Analgesic intake comparison after root canal treatment with two different irrigation methods at 48-72 hours.	The patients were asked to choose one of the two options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep".	48-72 hours