"Effect of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain"

Not Applicable

• Conditions: Endodontically Treated Teeth; Postoperative Pain
• Interventions: Procedure: Apical enlargement + Sonic Activation Assisted Irrigation; Procedure: Non Apical enlargement + Sonic Activation Assisted Irrigation; Procedure: Apical enlargement; Procedure: Non Apical enlargement

• Registration Number: NCT04314908
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Detailed Description

The aim of this clinical study is to evaluate the intensity and duration of postoperative pain after apical enlargement and sonic activation assisted irrigation procedures. Patients who have asymptomatic teeth required retreatment will include in this study and retreatment procedure will be applied to these teeth. One hundreds twenty asymptomatic teeth required retreatment will randomly participate into 4 treatment groups in terms of apical enlargement and sonic activation assisted irrigation procedure applied. The presence of postoperative pain will assess after 12, 24, 48, 72 hrs and 1 week. Postoperative pain will be recorded by each patient by using visual analogue pain scale. Before the treatments, the nature of the study, complications and associated risks will be totally explained and written informed consent will be obtained from all study participants. The local anesthetic will be applied before the treatment start. The routine retreatment procedure will be applied. Different final irrigation solutions will be applied in accordance to the manufacturers' instructions. At the end of treatment, each patient will be given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week. After one week the teeth will be examined according to for pain intensity, percussion \& palpation sensitivity, swelling, analgesic intake and clinical status.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-19
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-01
• Study Start: 2020-06-10
• Primary Completion: 2020-10-10
• Study Completion: 2021-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

-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.

Exclusion Criteria

-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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apical enlargement + Sonic Activation Assisted Irrigation	Apical enlargement + Sonic Activation Assisted Irrigation	Routine 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 + Sonic Activation Assisted Irrigation	Non Apical enlargement + Sonic Activation Assisted Irrigation	Routine 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.
Apical enlargement	Apical enlargement	Routine retreatment procedure will be performed at working length according to the apex locator at point "0".
Non Apical enlargement	Non Apical enlargement	Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS	Baseline, 12, 24, 48, 72 hours and 1 week.	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.