Evaluation of Postoperative Pain and Lesion Healing in Periapical Lesion-Affected Teeth Obturated With Different Root Canal Sealers
NCT ID: NCT07307807
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
64 participants
INTERVENTIONAL
2025-06-01
2026-01-01
Brief Summary
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Detailed Description
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Volunteers will be randomly selected from patients attending our clinic according to lesion size. A computer-assisted randomization method (www.randomizer.org) will be used. Root canal treatments will be completed using AH Plus or TotalFill BC root canal sealers.
The required sample size will consist of a total of 64 volunteers: 16 volunteers with PAI 2-3 scored teeth treated with AH Plus, 16 volunteers with PAI 4 scored teeth treated with AH Plus, 16 volunteers with PAI 2-3 scored teeth treated with TotalFill BC, and 16 volunteers with PAI 4 scored teeth treated with TotalFill BC.
After completion of the root canal treatments, postoperative radiographs will be obtained and follow-up will be performed at 6 months. Postoperative pain will be assessed at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as at 1 week following completion of the root canal treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TotalFill BC Sealer and PAI 4
Teeth with a PAI score of 4 obturated with TotalFill BC and completed in a single visit.
TotalFill BC Sealer and PAI 4
The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI score of 4. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings.
Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records.
Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.
AH Plus and PAI 2-3
Teeth with PAI scores of 2 and 3 that were obturated with AH Plus and completed in a single visit.
AH Plus and PAI 2-3
The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI scores of 2-3. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings.
Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records. Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.
AH Plus and PAI 4
Teeth with a PAI score of 4 that were obturated with AH Plus and completed in a single visit.
AH Plus and PAI 4
The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI score of 4. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings.
Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records.
Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated
TotalFill BC Sealer and PAI 2-3
Teeth with PAI scores of 2 and 3 obturated with TotalFill BC and completed in a single visit.
TotalFill BC Sealer and PAI 2-3
The TotalFill BC root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI scores of 2-3. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings.
Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records.
Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.
Interventions
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AH Plus and PAI 2-3
The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI scores of 2-3. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings.
Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records. Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.
AH Plus and PAI 4
The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI score of 4. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings.
Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records.
Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated
TotalFill BC Sealer and PAI 2-3
The TotalFill BC root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI scores of 2-3. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings.
Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records.
Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.
TotalFill BC Sealer and PAI 4
The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI score of 4. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings.
Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records.
Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.
Eligibility Criteria
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Inclusion Criteria
2. Teeth with periapical lesions (apical periodontitis) that have not undergone previous root canal treatment
3. Single-rooted maxillary and mandibular teeth
4. Teeth with PAI scores of 2, 3, and 4 according to the PAI classification
5. Teeth without a sinus tract or acute apical abscess
6. Patients who voluntarily agree to participate in the study and attend follow-up visits
7. Teeth with sufficient remaining tooth structure to allow restoration with a direct restoration after root canal treatment -
Exclusion Criteria
Pregnant or breastfeeding patients
Patients with traumatic malocclusion
Patients without occlusal contact
Teeth with root resorption, open apices, or calcification
Teeth presenting gingival recession greater than 3 mm, deep periodontal pockets, or mobility
Teeth with root fractures or cracks
Presence of an adjacent tooth requiring endodontic treatment that may cause referred pain
Multirooted teeth
Teeth with a PAI score of 5
Teeth requiring restorations such as endocrowns, onlays, overlays, or full crowns due to excessive loss of tooth structure after root canal treatment
Teeth with structural loss severe enough to require post-core application
Cases in which adequate anesthesia cannot be achieved with local anesthesia alone (requiring additional intrapulpal or intraligamentary anesthesia)
Teeth requiring active periodontal treatment
Individuals with severe systemic diseases
\-
18 Years
65 Years
ALL
No
Sponsors
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Ankara Yildirim Beyazıt University
OTHER
Responsible Party
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Neslihan Büşra Keskin
Assoc. Prof.
Principal Investigators
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Neslihan Büşra KESKİN KESKİN
Role: PRINCIPAL_INVESTIGATOR
Ankara Yıldırım Beyazıt University Faculty of Dentistry
Locations
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Ankara Yıldırım Beyazıt University
Ankara, Keçiören, Turkey (Türkiye)
Countries
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References
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Tan HSG, Lim KC, Lui JN, Lai WMC, Yu VSH. Postobturation Pain Associated with Tricalcium Silicate and Resin-based Sealer Techniques: A Randomized Clinical Trial. J Endod. 2021 Feb;47(2):169-177. doi: 10.1016/j.joen.2020.10.013. Epub 2020 Oct 22.
Hegde VR, Hegde SR, Fanibunda UE, Vartak MA. Comparative evaluation of postoperative pain and healing following root canal obturation with calcium silicate and bioactive glass-based sealers to epoxy resin-based sealers: A systematic review and meta-analysis. J Conserv Dent Endod. 2025 Mar;28(3):211-221. doi: 10.4103/JCDE.JCDE_8_25. Epub 2025 Mar 3.
Gotler M, Bar-Gil B, Ashkenazi M. Postoperative pain after root canal treatment: a prospective cohort study. Int J Dent. 2012;2012:310467. doi: 10.1155/2012/310467. Epub 2012 Mar 15.
de Oliveira CB, Rocha TG, Pintor AVB, Magno MB, Abrahao AC, Maia LC, Romanach MJ, Visconti MA. Using fractal analysis to assess periapical bone formation after endodontic treatment: A systematic review and meta-analysis. Imaging Sci Dent. 2025 Jun;55(2):126-138. doi: 10.5624/isd.20240221. Epub 2025 Apr 10.
Cosar M, Kandemir Demirci G, Caliskan MK. The effect of two different root canal sealers on treatment outcome and post-obturation pain in single-visit root canal treatment: A prospective randomized clinical trial. Int Endod J. 2023 Mar;56(3):318-330. doi: 10.1111/iej.13870. Epub 2022 Nov 22.
Other Identifiers
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2025/14-03(KA-25010)
Identifier Type: -
Identifier Source: org_study_id