An interventional study of AH Plus and BioRoot Flow in Asymptomatic Apical Periodontitis, sponsored by Karadeniz Technical University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Karadeniz Technical University · Not applicable, Interventional, and Treatment
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.
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.
Karadeniz Technical University is the lead sponsor of 150 studies on the registry; 19 are open to participants now.
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Individuals with single-rooted, single-canal permanent teeth requiring endodontic treatment.
Individuals with teeth diagnosed with asymptomatic apical periodontitis (2 ≤ PAI ≤ 4).
Exclusion Criteria:
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.
Individuals with symptomatic teeth.
Individuals with advanced periodontal disease.
Pregnant or breastfeeding individuals.
Participants received single-visit root canal treatment using AH Plus, an epoxy resin-based root canal sealer, with the cold lateral condensation technique.
Device: AH Plus
Participants received single-visit root canal treatment using BioRoot Flow, a bioceramic-based root canal sealer, with the cold lateral condensation technique.
Device: BioRoot Flow
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 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.
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.
Time frame: 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.
Time frame: 7 days after root canal treatment
Plan to share: No
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Ran from Apr 2026 to primary completion in Jun 2026, 2 months.
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