"Effect of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain"
The Clinical Comparative Evaluation of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain In Retreatment: A Prospective Randomized Clinical Trial
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
The purpose of this randomized clinical trial is to evaluate the incidence of postoperative pain after retreatment after apical enlargement and sonic activation assisted irrigation. The presence of postoperative pain will assess after retreatment cases at 12, 24, 48, 72 hrs and 1 week.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Jun 2020
Typical duration for not_applicable postoperative-pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2020
CompletedFirst Posted
Study publicly available on registry
March 19, 2020
CompletedStudy Start
First participant enrolled
June 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2021
CompletedMay 1, 2020
March 1, 2020
4 months
March 17, 2020
April 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS
The primary outcome measure of the study is to assess if sonic activation assisted irrigation and apical enlargement procedures influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale. Each patient recorded the pain level on a 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment. The VAS scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 25 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 50 mm and less than 75 mm. Intense pain was defined as equal to or greater than 75 mm. Intense pain included the descriptors of strong, severe, and maximum possible.
Baseline, 12, 24, 48, 72 hours and 1 week.
Study Arms (4)
Apical enlargement
EXPERIMENTALRoutine retreatment procedure will be performed at working length according to the apex locator at point "0".
Apical enlargement + Sonic Activation Assisted Irrigation
EXPERIMENTALRoutine retreatment procedure will be performed at working length according to the apex locator at point "0" and sonic activation assisted irrigation will be applied.
Non Apical enlargement
EXPERIMENTALRoutine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point.
Non Apical enlargement + Sonic Activation Assisted Irrigation
EXPERIMENTALRoutine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point and sonic activation assisted irrigation will be applied.
Interventions
The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will be opened. The working length will be measured using apex locator and the "0" point will be based on. After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary.
The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and the "0" point will be based on. After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals. Then the teeth were obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary.
The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on. After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary.
The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on. After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals. Then the teeth were obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary.
Eligibility Criteria
You may qualify if:
- Patients who were healthy volunteers and who have failed teeth required retreatment with periapical index score 3-5 score requiring root canal treatment for first time.
- Patients who were not included the study who;
- were pregnant or breast feeding during the duration of the study,
- have systemic disease, have any pain and/or any facial swelling, abscess,
- were immunocompromised,
- were under 18 yrs. and over 65 yrs. age,
- were taking antibiotics or corticosteroids within previous three days,
- have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral,
- have root canals that could not be well-treated with orthograde retreatment.
You may not qualify if:
- The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keziban Olcay, DDS, Phd
Medipol University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Double (Participant and Outcomes Assessor) The patients and outcome assessor were unaware as to which study group they had been allocated.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2020
First Posted
March 19, 2020
Study Start
June 10, 2020
Primary Completion
October 10, 2020
Study Completion
December 10, 2021
Last Updated
May 1, 2020
Record last verified: 2020-03