NCT04197531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

December 11, 2019

Last Update Submit

December 13, 2019

Conditions

Post Operative Pain

Keywords

EndoActivatorIrrigationPostoperative painPrimary teeth

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

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

    0-8 hours

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

    8-24 hours

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

    24-48 hours

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

    48-72 hours

Study Arms (2)

EndoActivator

EXPERIMENTAL
Other: Irrigation Method

Conventional Endodontic Syringe

EXPERIMENTAL
Other: Irrigation Method

Interventions

Irrigation MethodOTHER

Irrigation Method

Conventional Endodontic SyringeEndoActivator

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University, Faculty of Dentistry

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 25195661BACKGROUND

  • 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.

    PMID: 30815731BACKGROUND

  • 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.

    PMID: 33184717DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Hüsniye Gümüş, PHD., Dr.

    Erciyes University, Faculty of Dentistry

    STUDY DIRECTOR

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
PRINCIPAL INVESTIGATOR
PI Title
Study Director, PHD., Dr.

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 13, 2019

Study Start

April 1, 2018

Primary Completion

April 1, 2019

Study Completion

April 30, 2019

Last Updated

December 17, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)