Back to resultsPostoperative Pain After the Use of Different Last Irrigation Method During Root Canal Treatment in Primary Teeth
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Irrigation Method
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring EndoActivator, Irrigation, Postoperative pain, Primary teeth
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.
Sites / Locations
- Erciyes University, Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
EndoActivator
Conventional Endodontic Syringe
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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".
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".
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".
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".
Full Information
NCT ID
NCT04197531
First Posted
December 11, 2019
Last Updated
December 13, 2019
Sponsor
TC Erciyes University
1. Study Identification
Unique Protocol Identification Number
NCT04197531
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
EndoActivator, Irrigation, Postoperative pain, Primary teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EndoActivator
Arm Type
Experimental
Arm Title
Conventional Endodontic Syringe
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Irrigation Method
Intervention Description
Irrigation Method
Primary Outcome Measure Information:
Title
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 8th hours
Description
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.
Time Frame
8th hours
Title
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 24th hours
Description
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.
Time Frame
24th hours
Title
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 48th hours
Description
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.
Time Frame
48th hours
Title
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 72th hours
Description
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.
Time Frame
72th hours
Secondary Outcome Measure Information:
Title
Analgesic intake comparison after root canal treatment with two different irrigation methods at 0-8 hours.
Description
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".
Time Frame
0-8 hours
Title
Analgesic intake comparison after root canal treatment with two different irrigation methods at 8-24 hours.
Description
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".
Time Frame
8-24 hours
Title
Analgesic intake comparison after root canal treatment with two different irrigation methods at 24-48 hours.
Description
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".
Time Frame
24-48 hours
Title
Analgesic intake comparison after root canal treatment with two different irrigation methods at 48-72 hours.
Description
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".
Time Frame
48-72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hüsniye Gümüş, PHD., Dr.
Organizational Affiliation
Erciyes University, Faculty of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Erciyes University, Faculty of Dentistry
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25195661
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.
Results Reference
background
PubMed Identifier
30815731
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.
Results Reference
background
PubMed Identifier
33184717
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.
Results Reference
derived
Learn more about this trial
Postoperative Pain After the Use of Different Last Irrigation Method During Root Canal Treatment in Primary Teeth
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