Asymptomatic Apical PeriodontitisNCT07884799
Postoperative Pain and Quality of Life Following Root Canal Treatment With Two Different Sealers
A study testing AH Plus and BioRoot Flow in people with Asymptomatic Apical Periodontitis, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
This study compares two different root canal sealers, AH Plus and BioRoot Flow, to determine whether the type of sealer used during root canal treatment affects pain after treatment and oral health-related quality of life. Root canal treatment is performed to treat infection inside a tooth. 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?
- AH Plus and BioRoot Flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Jun 2026
- 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
- • Individuals without systemic diseases (ASA physical status I or II).
- Individuals with single-rooted, single-canal permanent teeth requiring endodontic treatment.
- Individuals with teeth diagnosed with asymptomatic apical periodontitis (2 ≤ PAI ≤ 4).
Who cannot join
- •Individuals with immature permanent teeth.
- Individuals with previously root canal-treated teeth.
- Individuals with systemic diseases.
- Individuals with teeth exhibiting internal or external root resorption or a history of dental trauma.
- Individuals who had taken analgesics within 24 hours before treatment.
- Individuals with calcified root canals.
Show all 9Show fewer
- Individuals with symptomatic teeth.
- Individuals with advanced periodontal disease.
- Pregnant or breastfeeding individuals.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Faculty of Dentistry
Trabzon, Ortahisar
About this study
Official title: Evaluation of the Effects of Resin-Based and Bioceramic-Based Root Canal Sealers on Postoperative Pain and Oral Health-Related Quality of Life Following Root Canal Obturation: A Randomized Clinical Trial
This study compares two different root canal sealers, AH Plus and BioRoot Flow, to determine whether the type of sealer used during root canal treatment affects pain after treatment and oral health-related quality of life.
Root canal treatment is performed to treat infection inside a tooth. Some patients may experience pain or discomfort after treatment, which can affect their daily activities and well-being.
Read more
The study includes adults with asymptomatic apical periodontitis in a permanent tooth with one root and one root canal. Participants are randomly assigned to receive root canal treatment using either AH Plus, a resin-based sealer, or BioRoot Flow, a bioceramic-based sealer. All participants receive treatment in a single visit.
Pain after treatment is assessed using a visual analog scale at 6 and 12 hours and on days 1, 2, 3, 5, 7, and 30. Oral health-related quality of life is assessed using the 14-item Oral Health Impact Profile (OHIP-14) questionnaire on day 7. The study also evaluates pain medication use and swelling after treatment.
The findings may help clinicians better understand patients' experiences following root canal treatment with these two sealers.
Read the detailed description
Apical periodontitis is an inflammatory condition affecting the tissues surrounding the root of a tooth and is associated with infection of the root canal system. Root canal treatment aims to control the infection through cleaning, shaping, and irrigation of the root canal, followed by filling of the prepared canal.
Root canal sealers are used with gutta-percha to fill spaces between the root canal filling material and the canal walls. Sealers with different chemical compositions are available, including epoxy resin-based and calcium silicate-based bioceramic materials. Postoperative pain is an important patient-reported outcome following root canal treatment. In addition, oral health-related quality of life provides information about how oral health affects patients' daily functioning and well-being.
This randomized, parallel-group clinical study compares an epoxy resin-based root canal sealer (AH Plus) with a premixed bioceramic root canal sealer (BioRoot Flow) in patients with asymptomatic apical periodontitis affecting single-rooted, single-canal permanent teeth.
A total of 58 participants are included, with 29 participants allocated to each treatment group. Root canal treatment is completed in a single visit, and cold lateral condensation is used for root canal obturation in both groups. The type of root canal sealer differs between the groups.
Postoperative pain is assessed using a visual analog scale (VAS) at 6 and 12 hours and on days 1, 2, 3, 5, 7, and 30 after treatment. Oral health-related quality of life is evaluated using the Turkish version of the 14-item Oral Health Impact Profile (OHIP-14-TR) on day 7 after treatment. Additional assessments include postoperative analgesic consumption, the presence of swelling, and radiographic evaluation of the root canal filling in relation to the apical foramen.
The study aims to compare postoperative pain and oral health-related quality of life between the two sealer groups and to provide clinical information about patient-reported outcomes following single-visit root canal treatment.
- Conditions
- Asymptomatic Apical Periodontitis
- Being tested
- AH Plus, BioRoot Flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AH PlusDevice
AH Plus, an epoxy resin-based root canal sealer, was used for root canal obturation in the control group. Root canal treatment was completed in a single visit, and obturation was performed using the cold lateral condensation technique with gutta-percha and AH Plus sealer
BioRoot FlowDevice
BioRoot Flow, a premixed calcium silicate-based bioceramic root canal sealer, was used for root canal obturation in the experimental group. Root canal treatment was completed in a single visit, and obturation was performed using the cold lateral condensation technique with gutta-percha and BioRoot Flow sealer.
| Study group | Role | What they receive |
|---|---|---|
| AH Plus | Active comparator | Participants received single-visit root canal treatment using AH Plus, an epoxy resin-based root canal sealer, with the cold lateral condensation technique. Receives: Device: AH Plus |
| BioRoot Flow | Experimental | Participants received single-visit root canal treatment using BioRoot Flow, a bioceramic-based root canal sealer, with the cold lateral condensation technique. Receives: Device: BioRoot Flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Assessed Using the Visual Analog Scale (VAS)
Postoperative pain intensity was assessed using a 100-mm visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst imaginable pain). Participants recorded their pain intensity at eight postoperative time points. Higher scores indicated greater pain intensity. VAS scores were compared between the AH Plus and BioRoot Flow groups.
Measured: 6 and 12 hours and 1, 2, 3, 5, 7, and 30 days after root canal treatment
Oral Health-Related Quality of Life Assessed Using the OHIP-14
Oral health-related quality of life was assessed using the Turkish version of the 14-item Oral Health Impact Profile (OHIP-14-TR) questionnaire. The questionnaire consists of 14 items across seven domains, with each item scored from 0 (never) to 4 (very often). Total scores range from 0 to 56, with higher scores indicating poorer oral health-related quality of life. OHIP-14 total scores were compared between the AH Plus and BioRoot Flow groups.
Measured: 7 days after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Apr 2026
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
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
- Participants were randomly assigned to one of two parallel groups. Both groups received single-visit root canal treatment using the cold lateral condensation technique. The only difference between the groups was the root canal sealer used: AH Plus (epoxy resin-based) or BioRoot Flow (bioceramic-based).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan Çelik Uzun, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884799
- Sponsor's protocol ID
- 25-AKD-201
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 21 Oct 2026
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Resin-Based and Bioceramic-Based Root Canal Sealers on Postoperative Pain and Oral Health-Related Quality of Life Following Root Canal Obturation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07884799
- Acronym / sponsor ID
- 25-AKD-201
- Conditions
- Asymptomatic Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 21 Oct 2026 (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 compares two different root canal sealers, AH Plus and BioRoot Flow, to determine whether the type of sealer used during root canal treatment affects pain after treatment and oral health-related quality of life.
Root canal treatment is performed to treat infection inside a tooth. Some patients may experience pain or discomfort after treatment, which can affect their daily activities and well-being.
The study includes adults with asymptomatic apical periodontitis in a permanent tooth with one root and one root canal. Participants are randomly assigned to receive root canal treatment using either AH Plus, a resin-based sealer, or BioRoot Flow, a bioceramic-based sealer. All participants receive treatment in a single visit.
Pain after treatment is assessed using a visual analog scale at 6 and 12 hours and on days 1, 2, 3, 5, 7, and 30. Oral health-related quality of life is assessed using the 14-item Oral Health Impact Profile (OHIP-14) questionnaire on day 7. The study also evaluates pain medication use and swelling after treatment.
The findings may help clinicians better understand patients' experiences following root canal treatment with these two sealers.
Detailed description
Apical periodontitis is an inflammatory condition affecting the tissues surrounding the root of a tooth and is associated with infection of the root canal system. Root canal treatment aims to control the infection through cleaning, shaping, and irrigation of the root canal, followed by filling of the prepared canal.
Root canal sealers are used with gutta-percha to fill spaces between the root canal filling material and the canal walls. Sealers with different chemical compositions are available, including epoxy resin-based and calcium silicate-based bioceramic materials. Postoperative pain is an important patient-reported outcome following root canal treatment. In addition, oral health-related quality of life provides information about how oral health affects patients' daily functioning and well-being.
This randomized, parallel-group clinical study compares an epoxy resin-based root canal sealer (AH Plus) with a premixed bioceramic root canal sealer (BioRoot Flow) in patients with asymptomatic apical periodontitis affecting single-rooted, single-canal permanent teeth.
A total of 58 participants are included, with 29 participants allocated to each treatment group. Root canal treatment is completed in a single visit, and cold lateral condensation is used for root canal obturation in both groups. The type of root canal sealer differs between the groups.
Postoperative pain is assessed using a visual analog scale (VAS) at 6 and 12 hours and on days 1, 2, 3, 5, 7, and 30 after treatment. Oral health-related quality of life is evaluated using the Turkish version of the 14-item Oral Health Impact Profile (OHIP-14-TR) on day 7 after treatment. Additional assessments include postoperative analgesic consumption, the presence of swelling, and radiographic evaluation of the root canal filling in relation to the apical foramen.
The study aims to compare postoperative pain and oral health-related quality of life between the two sealer groups and to provide clinical information about patient-reported outcomes following single-visit root canal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups. Both groups received single-visit root canal treatment using the cold lateral condensation technique. The only difference between the groups was the root canal sealer used: AH Plus (epoxy resin-based) or BioRoot Flow (bioceramic-based).
| Arm | Type | Receives |
|---|---|---|
| AH Plus | Active comparator | Device: AH PlusParticipants received single-visit root canal treatment using AH Plus, an epoxy resin-based root canal sealer, with the cold lateral condensation technique. |
| BioRoot Flow | Experimental | Device: BioRoot FlowParticipants received single-visit root canal treatment using BioRoot Flow, a bioceramic-based root canal sealer, with the cold lateral condensation technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Individuals without systemic diseases (ASA physical status I or II).
- Individuals with single-rooted, single-canal permanent teeth requiring endodontic treatment.
- Individuals with teeth diagnosed with asymptomatic apical periodontitis (2 ≤ PAI ≤ 4).
Key exclusion criteria (9 listed)
- •Individuals with immature permanent teeth.
- Individuals with previously root canal-treated teeth.
- Individuals with systemic diseases.
- Individuals with teeth exhibiting internal or external root resorption or a history of dental trauma.
- Individuals who had taken analgesics within 24 hours before treatment.
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 PlusAH Plus, an epoxy resin-based root canal sealer, was used for root canal obturation in the control group. Root canal treatment was completed in a single visit, and obturation was performed using the cold lateral condensation technique with gutta-percha and AH Plus sealer | Device | AH Plus |
| BioRoot FlowBioRoot Flow, a premixed calcium silicate-based bioceramic root canal sealer, was used for root canal obturation in the experimental group. Root canal treatment was completed in a single visit, and obturation was performed using the cold lateral condensation technique with gutta-percha and BioRoot Flow sealer. | Device | BioRoot Flow |
Primary outcome
Postoperative Pain Intensity Assessed Using the Visual Analog Scale (VAS)
Time frame: 6 and 12 hours and 1, 2, 3, 5, 7, and 30 days after root canal treatment
Postoperative pain intensity was assessed using a 100-mm visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst imaginable pain). Participants recorded their pain intensity at eight postoperative time points. Higher scores indicated greater pain intensity. VAS scores were compared between the AH Plus and BioRoot Flow groups.
Oral Health-Related Quality of Life Assessed Using the OHIP-14
Time frame: 7 days after root canal treatment
Oral health-related quality of life was assessed using the Turkish version of the 14-item Oral Health Impact Profile (OHIP-14-TR) questionnaire. The questionnaire consists of 14 items across seven domains, with each item scored from 0 (never) to 4 (very often). Total scores range from 0 to 56, with higher scores indicating poorer oral health-related quality of life. OHIP-14 total scores were compared between the AH Plus and BioRoot Flow 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 21 Oct 2026.
- 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 AH Plus and BioRoot Flow in people with Asymptomatic Apical Periodontitis, run by Karadeniz Technical 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 3 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 21 Oct 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 Assessed Using the Visual Analog Scale (VAS) (time frame: 6 and 12 hours and 1, 2, 3, 5, 7, and 30 days after root canal treatment). The study lists 2 primary outcomes in all. 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 21 Oct 2026.