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The root canal treatment of volunteers with asymptomatic apical periodontitis will be completed using TotalFill BC and AH Plus root canal sealers, and postoperative pain as well as healing will be comparatively evaluated through radiographic follow-ups at predetermined time intervals.
The study is planned as a randomized controlled clinical trial. The randomized controlled study will be conducted at the Ankara Yıldırım Beyazıt University Faculty of Dentistry, Department of Endodontics, and will include adult volunteers who have been diagnosed with asymptomatic apical periodontitis, present periapical lesions with PAI scores of 2, 3, and 4, have an indication for root canal treatment, meet the inclusion criteria of the study, and have provided written informed consent.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AH Plus and PAI 2-3 | Experimental | Teeth with PAI scores of 2 and 3 that were obturated with AH Plus and completed in a single visit. |
|
| AH Plus and PAI 4 | Experimental | Teeth with a PAI score of 4 that were obturated with AH Plus and completed in a single visit. |
|
| TotalFill BC Sealer and PAI 2-3 | Experimental | Teeth with PAI scores of 2 and 3 obturated with TotalFill BC and completed in a single visit. |
|
| TotalFill BC Sealer and PAI 4 | Experimental | Teeth with a PAI score of 4 obturated with TotalFill BC and completed in a single visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AH Plus and PAI 2-3 | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fractal analysis | In this study, fractal analysis of each sample will be performed using the box-counting method. | 6. month |
| VAS scala | 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, on a form using the Visual Analog Scale (VAS). One week after treatment, volunteers will be contacted by telephone, and the pain scores indicated on the pain assessment forms will be obtained and recorded in the patient files. | 6.,12.,24.,36.,48.,72. hours and 1 week |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have used antibiotics, analgesics, or anti-inflammatory drugs within the last 7 days
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
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| Name | Affiliation | Role |
|---|---|---|
| Neslihan Büşra KESKİN KESKİN | Ankara Yıldırım Beyazıt University Faculty of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Yıldırım Beyazıt University | Ankara | Keçiören | 06490 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40256693 | Background | 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. | |
| 22505897 |
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The bioistatician performing the data analysis will be blinded to group allocation. The clinician performing the treatments will not be blinded.
|
| AH Plus and PAI 4 | Procedure | 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 | Procedure | 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 | Procedure | 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. |
|
| 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. |
| 40607066 | Background | 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. |
| 36385378 | Background | 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. |
| 33098889 | Background | 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. |
| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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