- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07246174
Comparison of AH Plus and WellRootST Root Canal Sealers in Terms of Postoperative Pain: One-Month Follow-up
November 17, 2025 updated by: Furkan Salih Bilgi, Medipol University
The objective of this research was to identify which of the root canal sealers, AH Plus or WellRootST, yielded more effective outcomes regarding postoperative pain when applied to teeth diagnosed with apical periodontitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A prospective cohort study was conducted at a single center, involving 120 patients diagnosed with chronic apical periodontitis (AP) admitted for endodontic treatment.
Patients were categorized into two groups based on the type of root canal sealer used.
Sixty patients treated with AH Plus sealer constituted Group 1, while sixty patients treated with WellRootST sealer comprised Group 2. Data collected for all participants included age, gender, findings from oral and dental examinations, tooth type, tooth number, duration of root canal treatment, and Visual Analog Scale (VAS) results recorded preoperatively, as well as at 24 hours, 48 hours, 72 hours, 1 week, and 1 month postoperatively.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- İstanbul Medipol University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
The inclusion criteria for this study were as follows:
- Participants had to be at least 18 years old
- One mature tooth showing signs or symptoms that required primary root canal treatment.
- Participants needed to be in good general health
- classified as ASA I or II, and able to follow the follow-up schedule.
Exclusion criteria criteria for this study were as follows:
- Included teeth with internal or external root resorption,
- Signs of perforation
- The need for post-core application, or previous restoration with fixed prosthetic appliances, such as crowns or bridges
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AhPlus sealer
AH Plus sealer used
|
AhPlus sealer was used for group 1
|
|
Experimental: WellRootST sealer
WellRootST sealer used
|
WellRootSt wa used for group 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain evaluation by VAS scale
Time Frame: Baseline, 24 hour postoperatively, 48hour postoperatively, 72 hour postoperatively, Day 3 and Day 7
|
Study groups were compared in terms of VAS scores at the preoperative period and postoperative 24 hours, 48 hours, 72 hours, 1 week, and 1 month
|
Baseline, 24 hour postoperatively, 48hour postoperatively, 72 hour postoperatively, Day 3 and Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Furkan S Bilgi, PhD, Medipol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
November 1, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
November 14, 2025
First Submitted That Met QC Criteria
November 17, 2025
First Posted (Actual)
November 24, 2025
Study Record Updates
Last Update Posted (Actual)
November 24, 2025
Last Update Submitted That Met QC Criteria
November 17, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-243
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Upon request from the authors with a reasonable request, our data will be made open
IPD Sharing Time Frame
After the acceptance of our study
IPD Sharing Access Criteria
Our data will be shared via email
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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