Asymptomatic Apical PeriodontitisNCT07289633
Evaluation of Postoperative Pain After Using Resin-Based and Bioceramic Sealers in Mandibular Molars With Asymptomatic Apical Periodontitis
A study testing BioRoot RCS and AH Plus in people with Asymptomatic Apical Periodontitis, run by AZİZ ŞAHİN ERDOĞAN at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of two different root canal sealers-BioRoot RCS (a bioceramic-based sealer) and AH Plus (a resin-based sealer)-on postoperative pain following single-visit root canal treatment in mandibular first and second molars diagnosed with asymptomatic apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asymptomatic Apical Periodontitis
- What is being tested?
- BioRoot RCS and AH Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Mar 2025to 2 Oct 2025
- 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
- Patients aged 18 years or older with adequate oral hygiene.
- Teeth with no previous endodontic or restorative treatment.
- Teeth that do not respond to cold test and electric pulp test during vitality assessment.
- Teeth that are asymptomatic prior to treatment.
- Mandibular first or second molar teeth with complete root development.
- No bleeding observed in the pulp chamber after caries removal.
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- Teeth with a Periapical Index (PAI) score of 3 or less.
- Patients who have not used antibiotics within the last 1 month.
- Patients who have not used analgesics within the last 72 hours.
Who cannot join
- Presence of systemic diseases that may affect healing (e.g., uncontrolled diabetes, immunosuppression).
- Pregnancy or breastfeeding.
- Teeth with a history of trauma, resorption, or previous endodontic access.
- Teeth with root canal calcifications or anatomical abnormalities preventing standard instrumentation.
- Presence of sinus tract, swelling, or acute apical abscess.
- Teeth with a Periapical Index (PAI) score greater than 3.
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- Patients taking medications that may alter pain perception (e.g., corticosteroids, neuropathic pain medications).
- Patients unable to comply with follow-up pain recordings.
- Patients with known allergy to any materials used in the study (e.g., sodium hypochlorite, sealers).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Dentistry
Erzurum, palandöken, 25100
About this study
Official title: Evaluation of the Effect of Resin-Based and Bioceramic Sealers on Postoperative Pain in Mandibular Molars With Asymptomatic Apical Periodontitis Treated in a Single Visit
This study aims to evaluate the effect of two different root canal sealers-BioRoot RCS (a bioceramic-based sealer) and AH Plus (a resin-based sealer)-on postoperative pain following single-visit root canal treatment in mandibular first and second molars diagnosed with asymptomatic apical periodontitis. Postoperative pain levels will be assessed at multiple time intervals to determine whether the type of canal sealer influences patient discomfort after treatment.
Read the detailed description
Asymptomatic apical periodontitis is a common condition requiring root canal treatment, and postoperative pain is an important outcome that affects patient comfort and clinical decision-making. Root canal sealers play a critical role in the success of endodontic therapy, and their physical and biological properties may influence postoperative symptoms.
This study compares a bioceramic-based sealer (BioRoot RCS) and a resin-based sealer (AH Plus) in patients receiving single-visit root canal treatment for mandibular first and second molars with asymptomatic apical periodontitis. Participants will be randomly assigned to one of the two sealer groups. Pain intensity will be recorded using a validated pain scale at predetermined time intervals following treatment. The findings of this study may help clinicians select sealers based on their impact on postoperative pain and improve patient outcomes.
- Conditions
- Asymptomatic Apical Periodontitis
- Being tested
- BioRoot RCS, AH Plus
- Keywords
- Root Canal Treatment, Postoperative Pain, BioRoot RCS, AH Plus, Mandibular Molars
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioRoot RCSOther
Single-visit root canal treatment was performed on mandibular molar teeth diagnosed with asymptomatic apical periodontitis. After shaping and irrigation, the canals were obturated using the BioRoot RCS bioceramic-based sealer with a single-cone technique. No additional medicament or adjunctive procedure was used.
AH PlusOther
Single-visit root canal treatment was performed on mandibular molar teeth diagnosed with asymptomatic apical periodontitis. After shaping and irrigation, the canals were obturated using the AH Plus resin-based sealer with a single-cone technique. No additional medicament or adjunctive procedure was used.
| Study group | Role | What they receive |
|---|---|---|
| BioRoot RCS Group | Experimental | Single-visit root canal treatment using BioRoot RCS (bioceramic sealer) Receives: Other: BioRoot RCS |
| AH Plus Group | Active comparator | Single-visit root canal treatment using AH Plus (resin-based sealer) Receives: Other: AH Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Level
Postoperative pain will be recorded using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will report their pain levels at 24 hours post-treatment, 48 hours post-treatment, 72 hours post-treatment, and on 7 days post-treatment following single-visit root canal treatment.
Measured: First 7 days after treatment (24 hours, 48 hours, 72 hours, and 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start12 Mar 2025
- Primary completion25 Sep 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Apical PeriodontitisStudies of the same condition, open and under way.
- 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
- Model description
- This study uses a parallel assignment model in which participants are randomly allocated to one of two treatment groups receiving either a bioceramic-based sealer (BioRoot RCS) or a resin-based sealer (AH Plus) during single-visit root canal treatment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZİZ ŞAHİN ERDOĞAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AZİZ ŞAHİN ERDOĞAN, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289633
- Sponsor's protocol ID
- B.30.2ATA.0.01.00/559
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Resin-Based and Bioceramic Sealers on Postoperative Pain in Mandibular Molars With Asymptomatic Apical Periodontitis Treated in a Single Visit
- ClinicalTrials.gov ID
- NCT07289633
- Acronym / sponsor ID
- B.30.2ATA.0.01.00/559
- Conditions
- Asymptomatic Apical Periodontitis
- Keywords
- Root Canal Treatment, Postoperative Pain, BioRoot RCS, AH Plus, Mandibular Molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- AZİZ ŞAHİN ERDOĞANUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 17 Dec 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 study aims to evaluate the effect of two different root canal sealers-BioRoot RCS (a bioceramic-based sealer) and AH Plus (a resin-based sealer)-on postoperative pain following single-visit root canal treatment in mandibular first and second molars diagnosed with asymptomatic apical periodontitis. Postoperative pain levels will be assessed at multiple time intervals to determine whether the type of canal sealer influences patient discomfort after treatment.
Detailed description
Asymptomatic apical periodontitis is a common condition requiring root canal treatment, and postoperative pain is an important outcome that affects patient comfort and clinical decision-making. Root canal sealers play a critical role in the success of endodontic therapy, and their physical and biological properties may influence postoperative symptoms.
This study compares a bioceramic-based sealer (BioRoot RCS) and a resin-based sealer (AH Plus) in patients receiving single-visit root canal treatment for mandibular first and second molars with asymptomatic apical periodontitis. Participants will be randomly assigned to one of the two sealer groups. Pain intensity will be recorded using a validated pain scale at predetermined time intervals following treatment. The findings of this study may help clinicians select sealers based on their impact on postoperative pain and improve patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment model in which participants are randomly allocated to one of two treatment groups receiving either a bioceramic-based sealer (BioRoot RCS) or a resin-based sealer (AH Plus) during single-visit root canal treatment.
| Arm | Type | Receives |
|---|---|---|
| BioRoot RCS Group | Experimental | Other: BioRoot RCSSingle-visit root canal treatment using BioRoot RCS (bioceramic sealer) |
| AH Plus Group | Active comparator | Other: AH PlusSingle-visit root canal treatment using AH Plus (resin-based sealer) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18 years or older with adequate oral hygiene.
- Teeth with no previous endodontic or restorative treatment.
- Teeth that do not respond to cold test and electric pulp test during vitality assessment.
- Teeth that are asymptomatic prior to treatment.
- Mandibular first or second molar teeth with complete root development.
Key exclusion criteria (9 listed)
- Presence of systemic diseases that may affect healing (e.g., uncontrolled diabetes, immunosuppression).
- Pregnancy or breastfeeding.
- Teeth with a history of trauma, resorption, or previous endodontic access.
- Teeth with root canal calcifications or anatomical abnormalities preventing standard instrumentation.
- Presence of sinus tract, swelling, or acute apical abscess.
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 |
|---|---|---|
| BioRoot RCSSingle-visit root canal treatment was performed on mandibular molar teeth diagnosed with asymptomatic apical periodontitis. After shaping and irrigation, the canals were obturated using the BioRoot RCS bioceramic-based sealer with a single-cone technique. No additional medicament or adjunctive procedure was used. | Other | BioRoot RCS Group |
| AH PlusSingle-visit root canal treatment was performed on mandibular molar teeth diagnosed with asymptomatic apical periodontitis. After shaping and irrigation, the canals were obturated using the AH Plus resin-based sealer with a single-cone technique. No additional medicament or adjunctive procedure was used. | Other | AH Plus Group |
Primary outcome
Postoperative Pain Level
Time frame: First 7 days after treatment (24 hours, 48 hours, 72 hours, and 7 days)
Postoperative pain will be recorded using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will report their pain levels at 24 hours post-treatment, 48 hours post-treatment, 72 hours post-treatment, and on 7 days post-treatment following single-visit root canal treatment.
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 17 Dec 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioRoot RCS and AH Plus in people with Asymptomatic Apical Periodontitis, run by AZİZ ŞAHİN ERDOĞAN 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 9 inclusion and 9 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 17 Dec 2025. 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 Level (time frame: First 7 days after treatment (24 hours, 48 hours, 72 hours, and 7 days)). 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 17 Dec 2025.