Apical PeriodontitisNCT07246174
Comparison of AH Plus and WellRootST Root Canal Sealers in Terms of Postoperative Pain: One-Month Follow-up
A study testing AH Plus Root Canal Sealer and Well-Root ST Root Canal Sealer in people with Apical Periodontitis, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This randomized, parallel-group clinical trial aimed to compare the effects of two root canal sealers, AH Plus and Well-Root ST, on postoperative pain in patients undergoing single-visit root canal treatment for teeth diagnosed with apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- AH Plus Root Canal Sealer and Well-Root ST Root Canal Sealer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged between 18 and 65 years. Presence of a mature permanent tooth requiring primary root canal treatment. Good general health status, classified as ASA physical status I or II. Ability to comply with the scheduled follow-up assessments.
Who cannot join
- Use of analgesics or antibiotics within 48 hours before treatment. Pregnancy. Presence of periodontal disease. Teeth that had previously undergone root canal treatment. Teeth with immature root development or open apices. Teeth presenting with internal or external root resorption. Teeth presenting with root perforation. Teeth requiring post-and-core restoration. Teeth previously restored with fixed prosthetic restorations, such as crowns or bridges.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized, parallel-group clinical trial aimed to compare the effects of two root canal sealers, AH Plus and Well-Root ST, on postoperative pain in patients undergoing single-visit root canal treatment for teeth diagnosed with apical periodontitis.
A total of 120 patients were allocated to two treatment groups (n = 60 per group) using a sealed-envelope allocation method. Participants were unaware of which root canal sealer was used during their treatment.
Postoperative pain was assessed using a visual analog scale (VAS) at 24, 48, and 72 hours, 1 week, and 1 month after treatment.
Read the detailed description
This single-center, randomized, parallel-group clinical trial included 120 patients diagnosed with apical periodontitis who underwent single-visit root canal treatment.
Participants were allocated to two treatment groups using a sealed-envelope method. A total of 120 identical, opaque, sealed envelopes were prepared, with 60 assignments for the AH Plus group and 60 assignments for the Well-Root ST group. The envelopes were manually shuffled before patient enrollment. Each participant selected an envelope immediately before treatment, and the assigned root canal sealer was used.
Group 1 consisted of 60 patients treated with AH Plus root canal sealer, while Group 2 consisted of 60 patients treated with Well-Root ST root canal sealer. Participants were unaware of which sealer was used during treatment, whereas the treating operator was not blinded.
Data collected included age, sex, clinical examination findings, tooth type and number, duration of root canal treatment, and preoperative and postoperative pain scores.
Pain intensity was assessed using a visual analog scale (VAS) before treatment and at 24 hours, 48 hours, 72 hours, 1 week, and 1 month after treatment.
The primary objective was to compare postoperative pain intensity between the two root canal sealer groups.
- Conditions
- Apical Periodontitis
- Being tested
- AH Plus Root Canal Sealer, Well-Root ST Root Canal Sealer
- Keywords
- epoxy-resin-based root canal sealers, Calcium silicate-based root canal sealer, postoperative pain, Visual Analog Scale
- Medical subject headings
- Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AH Plus Root Canal SealerDevice
Epoxy resin-based root canal sealer used during single-visit root canal treatment.
Well-Root ST Root Canal SealerDevice
Calcium silicate-based bioceramic root canal sealer used during single-visit root canal treatment.
| Study group | Role | What they receive |
|---|---|---|
| Ah Plus | Active comparator | Participants assigned to this group underwent single-visit root canal treatment using AH Plus epoxy resin-based root canal sealer. A total of 60 participants received this intervention. Receives: Device: AH Plus Root Canal Sealer |
| Well-Root ST | Experimental | Participants assigned to this group underwent single-visit root canal treatment using Well-Root ST calcium silicate-based bioceramic root canal sealer. A total of 60 participants received this intervention. Receives: Device: Well-Root ST Root Canal Sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Measured Using a Visual Analog Scale (VAS)
Postoperative pain intensity was assessed using a 10-cm visual analog scale (VAS). Participants recorded their pain intensity before treatment (baseline) and at specified postoperative time points. VAS scores were compared between the AH Plus and Well-Root ST groups.
Measured: Baseline (preoperative), and 24 hours, 48 hours, 72 hours, 7 days, and 1 month postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jan 2024
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan Salih Bilgi, Medipol University
- Investigators
- Furkan S Bilgi, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246174
- Sponsor's protocol ID
- E-10840098-772.02-243
- Status last verified
- Nov 2026
- First submitted
- 14 Nov 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request from the authors with a reasonable request, our data will be made open
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of AH Plus and WellRootST Root Canal Sealers in Terms of Postoperative Pain: One-Month Follow-up
- ClinicalTrials.gov ID
- NCT07246174
- Acronym / sponsor ID
- E-10840098-772.02-243
- Conditions
- Apical Periodontitis
- Keywords
- epoxy-resin-based root canal sealers, Calcium silicate-based root canal sealer, postoperative pain, Visual Analog Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, parallel-group clinical trial aimed to compare the effects of two root canal sealers, AH Plus and Well-Root ST, on postoperative pain in patients undergoing single-visit root canal treatment for teeth diagnosed with apical periodontitis.
A total of 120 patients were allocated to two treatment groups (n = 60 per group) using a sealed-envelope allocation method. Participants were unaware of which root canal sealer was used during their treatment.
Postoperative pain was assessed using a visual analog scale (VAS) at 24, 48, and 72 hours, 1 week, and 1 month after treatment.
Detailed description
This single-center, randomized, parallel-group clinical trial included 120 patients diagnosed with apical periodontitis who underwent single-visit root canal treatment.
Participants were allocated to two treatment groups using a sealed-envelope method. A total of 120 identical, opaque, sealed envelopes were prepared, with 60 assignments for the AH Plus group and 60 assignments for the Well-Root ST group. The envelopes were manually shuffled before patient enrollment. Each participant selected an envelope immediately before treatment, and the assigned root canal sealer was used.
Group 1 consisted of 60 patients treated with AH Plus root canal sealer, while Group 2 consisted of 60 patients treated with Well-Root ST root canal sealer. Participants were unaware of which sealer was used during treatment, whereas the treating operator was not blinded.
Data collected included age, sex, clinical examination findings, tooth type and number, duration of root canal treatment, and preoperative and postoperative pain scores.
Pain intensity was assessed using a visual analog scale (VAS) before treatment and at 24 hours, 48 hours, 72 hours, 1 week, and 1 month after treatment.
The primary objective was to compare postoperative pain intensity between the two root canal sealer groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ah Plus | Active comparator | Device: AH Plus Root Canal SealerParticipants assigned to this group underwent single-visit root canal treatment using AH Plus epoxy resin-based root canal sealer. A total of 60 participants received this intervention. |
| Well-Root ST | Experimental | Device: Well-Root ST Root Canal SealerParticipants assigned to this group underwent single-visit root canal treatment using Well-Root ST calcium silicate-based bioceramic root canal sealer. A total of 60 participants received this intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants aged between 18 and 65 years. Presence of a mature permanent tooth requiring primary root canal treatment. Good general health status, classified as ASA physical status I or II. Ability to comply with the scheduled follow-up assessments.
Key exclusion criteria (1 listed)
- Use of analgesics or antibiotics within 48 hours before treatment. Pregnancy. Presence of periodontal disease. Teeth that had previously undergone root canal treatment. Teeth with immature root development or open apices. Teeth presenting with internal or external root resorption. Teeth presenting with root perforation. Teeth requiring post-and-core restoration. Teeth previously restored with fixed prosthetic restorations, such as crowns or bridges.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AH Plus Root Canal SealerEpoxy resin-based root canal sealer used during single-visit root canal treatment. | Device | Ah Plus |
| Well-Root ST Root Canal SealerCalcium silicate-based bioceramic root canal sealer used during single-visit root canal treatment. | Device | Well-Root ST |
Primary outcome
Postoperative Pain Intensity Measured Using a Visual Analog Scale (VAS)
Time frame: Baseline (preoperative), and 24 hours, 48 hours, 72 hours, 7 days, and 1 month postoperatively.
Postoperative pain intensity was assessed using a 10-cm visual analog scale (VAS). Participants recorded their pain intensity before treatment (baseline) and at specified postoperative time points. VAS scores were compared between the AH Plus and Well-Root ST groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. Upon request from the authors with a reasonable request, our data will be made open
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Furkan S Bilgi, PhD principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AH Plus Root Canal Sealer and Well-Root ST Root Canal Sealer in people with Apical Periodontitis, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity Measured Using a Visual Analog Scale (VAS) (time frame: Baseline (preoperative), and 24 hours, 48 hours, 72 hours, 7 days, and 1 month postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.