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A randomized clinical trial will compare two root canal filling approaches in necrotic single-rooted teeth. The test group will receive bioceramic mono-block obturation using bioceramic nano-coated gutta-percha with a bioceramic sealer, while the control group will receive traditional gutta-percha with a resin-based sealer. The main aim is to determine whether the bioceramic system can reduce postoperative pain and swelling within 48 hours after treatment compared with the conventional method. Patients aged 20-55 years who have necrotic single-rooted teeth and meet specific clinical and radiographic criteria will be recruited from the outpatient clinics of the Faculty of Dentistry, Cairo University.
Postoperative pain will be measured using a visual analogue scale, and swelling will be assessed using a standardized swelling score at 24 and 48 hours. The study hypothesizes that the bioceramic mono-block technique, due to its improved sealing ability and bioactivity, may lead to less postoperative discomfort and better early clinical outcomes than the gold-standard resin-sealer technique. The findings are expected to provide evidence to guide clinicians on whether adopting bioceramic nano-enhanced obturation can improve patient-centered outcomes after root canal treatment.
This randomized clinical study aims to compare the clinical and radiographic outcomes of root canal obturation using a bioceramic sealer with bioceramic-coated gutta-percha versus conventional obturation using a resin-based sealer with conventional gutta-percha. The study will be conducted on patients requiring endodontic treatment according to the established inclusion and exclusion criteria.
Participants will be randomly allocated into two groups. The control group will receive obturation using conventional gutta-percha with a resin-based sealer, while the experimental group will receive obturation using bioceramic-coated gutta-percha with a bioceramic sealer. Standardized endodontic treatment procedures will be performed for all participants.
Clinical and radiographic evaluations will be carried out during the follow-up period to assess treatment success, postoperative pain, postoperative swelling, and obturation quality. The outcomes of this study may help determine the effectiveness and clinical performance of bioceramic obturation materials compared with conventional obturation techniques in endodontic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional obturation group. | Active Comparator | Root canal obturation using resin-based sealer with conventional gutta-percha. |
|
| Bioceramic obturation group. | Experimental | Root canal obturation using bioceramic sealer with bioceramic coated gutta-percha. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resin sealer with conventional gutta percha. | Procedure | It is the gold standard obturation technique which will be used as the control group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain assessed by using a 10 cm Visual Analogue Scale. | Pain will be assessed using a 10 cm Visual analogue Scale from 0-10, where 0 indicates no pain, 1-3 Mild pain, 4-6 Moderate Pain and 7-10 Sever pain. Participants will be asked to verbally report their pain score after 24 hours and 48 hours. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative swelling assessed by using a 4 point Numerical Rating Scale. | Postoperative swelling will be assessed using a Numerical Rating scale. Assessment will be evaluated using a 4 point Numerical Rating Scale ranging from 0-3, where 0 indicates no swelling, 1 indicates mild intra oral swelling, 2 indicates moderate extra oral swelling, and 3 indicates sever swelling including more than one facial structure. The investigator will asses swelling at 24 hours and 48 hours. |
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Inclusion Criteria:
Patients aged 20-55 years. Patients with good oral hygiene, free of calculus, and with a probing depth not exceeding 2-3 mm.
Necrotic single-rooted, single-canal permanent teeth with or without periapical lesions. If lesion is present, ranging from 2-5 mm in size.
Absence of swelling. Medically free patients.
Exclusion Criteria:
Patients with poor oral hygiene. Vital teeth. Necrotic teeth without periapical lesions. Primary teeth. Complex root morphology other than Type I. Internal or external root resorption. Vertical root fractures. Cracked teeth. Intraoral or extraoral swelling.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hussein M Taha | Contact | +201004421891 | hussein.mohamed@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ghada Ehab ElWazzan, Lecturer | Cairo University | Study Director |
| Alaa ElBaz, Professor | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Out patient clinic Faculty of Dentistry Cairo University | Cairo | Cairo Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35735776 | Background | Pirani C, Camilleri J. Effectiveness of root canal filling materials and techniques for treatment of apical periodontitis: A systematic review. Int Endod J. 2023 Oct;56 Suppl 3:436-454. doi: 10.1111/iej.13787. Epub 2022 Jul 5. | |
| 40361773 | Background | Alghamdi A, Mominkhan D, Sabano R, Alqadi NF, Al-Habib M, Bukhari S, Howait M, Alsofi L. Factors Associated with Postsurgical Pain and Swelling Following Endodontic Microsurgery: The Role of Radiographic Characteristics. Healthcare (Basel). 2025 Apr 25;13(9):995. doi: 10.3390/healthcare13090995. |
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Age, Sex, Postoperative pain measurements, Postoperative swelling measurements, follow ups and radiographs.
Approximate start date will be at the end quarter of the year 2027.
Data will be available upon reasonable request to the principal investigator after publication of the study results.
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Biostatician
| Bioceramic sealer with bioceramic gutta-percha. | Procedure | Bioceramic sealer and bioceramic gutta-percha creating a monoblock for obturation of root canals. |
|
| 48 hours |
| 40746469 | Background | Swetha B, Priya BD, Reddy KH, Prasanthi G, Mohan TM, Tejaswi D. Comparative evaluation of bioactive calcium silicate coating on functionalized gutta-percha and its effect on bioceramic sealer wettability - An in vitro study. J Conserv Dent Endod. 2025 Jul;28(7):613-618. doi: 10.4103/JCDE.JCDE_159_25. Epub 2025 Jul 2. |
| Background | Somolová L et al. Comparison of apical microleakage in bioceramic and resin-based sealers with conventional and bioceramic surface-impregnated gutta-percha points. Ceramics. 2025. |
| 40079999 | Background | Rao MH, Krishnan R, Kumaraswamy M, Keshav A, Gopal P, Thomas E. Assessment of Treatment Outcomes with Complete Orthograde Obturation with Bioceramic Materials: A Scoping Review. J Contemp Dent Pract. 2024 Dec 1;25(12):1190-1197. doi: 10.5005/jp-journals-10024-3764. |
| 38606520 | Background | Zamparini F, Lenzi J, Duncan HF, Spinelli A, Gandolfi MG, Prati C. The efficacy of premixed bioceramic sealers versus standard sealers on root canal treatment outcome, extrusion rate and post-obturation pain: A systematic review and meta-analysis. Int Endod J. 2024 Aug;57(8):1021-1042. doi: 10.1111/iej.14069. Epub 2024 Apr 12. |
| 31794999 | Background | Fonseca B, Coelho MS, Bueno CEDS, Fontana CE, Martin AS, Rocha DGP. Assessment of Extrusion and Postoperative Pain of a Bioceramic and Resin-Based Root Canal Sealer. Eur J Dent. 2019 Jul;13(3):343-348. doi: 10.1055/s-0039-3399457. Epub 2019 Dec 3. |
| 29571915 | Background | Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20. |
| 40948576 | Background | Elmsmari F, Elsayed Y, Aboubakr A, Kaafarani M, Nour O, Pawar AM. Clinical and radiographic success of single-cone bioceramic obturation versus traditional techniques: a systematic review and meta-analysis of randomized controlled trials. J Oral Biol Craniofac Res. 2025 Nov-Dec;15(6):1422-1432. doi: 10.1016/j.jobcr.2025.08.031. Epub 2025 Sep 2. |
| Background | Abou-Elnaga MY, Refai AS, Alkhawas MA. Post operative pain and swelling evaluation following guided endodontic microsurgeries done using different treatment modalities: a clinical study. |
| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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