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

Sponsor
TC Erciyes University (Other)
Overall Status
Completed
CT.gov ID
NCT04197531
Collaborator
(none)
110
1
2
12.9
8.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Irrigation Method
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 1, 2018
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Apr 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: EndoActivator

Other: Irrigation Method
Irrigation Method

Experimental: Conventional Endodontic Syringe

Other: Irrigation Method
Irrigation Method

Outcome Measures

Primary Outcome Measures

  1. Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 8th hours [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.

  2. Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 24th hours [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.

  3. Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 48th hours [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.

  4. Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 72th hours [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.

Secondary Outcome Measures

  1. Analgesic intake comparison after root canal treatment with two different irrigation methods at 0-8 hours. [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".

  2. Analgesic intake comparison after root canal treatment with two different irrigation methods at 8-24 hours. [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".

  3. Analgesic intake comparison after root canal treatment with two different irrigation methods at 24-48 hours. [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".

  4. Analgesic intake comparison after root canal treatment with two different irrigation methods at 48-72 hours. [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".

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 9 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Erciyes University, Faculty of Dentistry Kayseri Turkey 38039

Sponsors and Collaborators

  • TC Erciyes University

Investigators

  • Study Director: Hüsniye Gümüş, PHD., Dr., Erciyes University, Faculty of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Husniye Gumus, Study Director, PHD., Dr., TC Erciyes University
ClinicalTrials.gov Identifier:
NCT04197531
Other Study ID Numbers:
  • 2018/152
First Posted:
Dec 13, 2019
Last Update Posted:
Dec 17, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Husniye Gumus, Study Director, PHD., Dr., TC Erciyes University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 17, 2019