Back to resultsEffect of Different Irrigation Activating Techniques on Irrigant Penetration Depth and on Post-Operative Pain
Primary Purpose
Irrigation Activation
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation
Sponsored by
About this trial
This is an interventional treatment trial for Irrigation Activation
Eligibility Criteria
Inclusion Criteria:
- Asymptomatic vital/non vital teeth requiring root canal treatment.
- Teeth with sound periodontal apparatus.
- Teeth without pus or inflammatory exudates draining through the canal.
- Teeth without anatomic variations.
- Teeth with sinus tract.
- Teeth without history of trauma.
- Patients not on analgesics or sedative medication prior to root canal therapy
Exclusion Criteria:
• Patients with any systemic diseases.
- Pregnant or lactating patients.
- Immunocompromised patients.
- Apparently thin roots in which apical preparation with #40 file would be overzealous.
- Patient allergic to anything used in this procedure especially rubber dam material and Iohexol (radiographic contrast media).
- Teeth with calcified canals.
- Patients with acute apical periodontitis, acute apical abscess, and weeping canals.
- Necrotic painful teeth with the absence of sinus tract for drainage.
Sites / Locations
- Faculty of Dentistry, Tanta University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
xp endo finisher file
new sonic EDDY system
syringe needle irrigation
Arm Description
Outcomes
Primary Outcome Measures
irrigant penetration depth
measurement of irrigant penetration depth using radioaque media and digital radiography
postoperative pain
evaluation of postoperative pain using visual analog scale VAS with scores from 0 to 100. score 0 indicated no pain while score 100 indicates maximum pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05450003
Brief Title
Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth and on Post-Operative Pain
Official Title
Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth Into Root Canals and on Post-Operative Pain After Single-Visit Endodontic Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
November 12, 2022 (Actual)
Study Completion Date
November 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Irrigation activation in endodontics is considered now a very important step for the success of root canal treatment. In this study, the investigator will examine the effect of two recent activation systems ( XP-endo Finisher file and the new sonic EDDY system) in comparison with the conventional needle irrigation on irrigant penetration depth into root canals using radiopaque contrast media and digital radiography and on the postoperative pain after single-visit endodontic treatment using a visual analog scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irrigation Activation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
the study will evaluate 3 groups of patients each consists of 10 participants receiving different type of irrigation activation.
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
xp endo finisher file
Arm Type
Other
Arm Title
new sonic EDDY system
Arm Type
Other
Arm Title
syringe needle irrigation
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation
Intervention Description
irrigation activation using 3 different irrigation activation systems including xp endo finisher file , new sonic eddy system and conventional needle syringe irrigation
Primary Outcome Measure Information:
Title
irrigant penetration depth
Description
measurement of irrigant penetration depth using radioaque media and digital radiography
Time Frame
through study completion, an average of 3 months
Title
postoperative pain
Description
evaluation of postoperative pain using visual analog scale VAS with scores from 0 to 100. score 0 indicated no pain while score 100 indicates maximum pain
Time Frame
through study completion, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Asymptomatic vital/non vital teeth requiring root canal treatment.
Teeth with sound periodontal apparatus.
Teeth without pus or inflammatory exudates draining through the canal.
Teeth without anatomic variations.
Teeth with sinus tract.
Teeth without history of trauma.
Patients not on analgesics or sedative medication prior to root canal therapy
Exclusion Criteria:
• Patients with any systemic diseases.
Pregnant or lactating patients.
Immunocompromised patients.
Apparently thin roots in which apical preparation with #40 file would be overzealous.
Patient allergic to anything used in this procedure especially rubber dam material and Iohexol (radiographic contrast media).
Teeth with calcified canals.
Patients with acute apical periodontitis, acute apical abscess, and weeping canals.
Necrotic painful teeth with the absence of sinus tract for drainage.
Facility Information:
Facility Name
Faculty of Dentistry, Tanta University
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth and on Post-Operative Pain
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