Comparing Obturation Using Bioceramic Nano-coated Gutta-percha With Bioceramic Sealer Versus Traditional Gutta-percha With Resin Sealer for Reducing Postoperative Pain and Swelling After Root Canal Treatment in Necrotic Single-rooted Teeth.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Resin sealer with conventional gutta percha., Bioceramic sealer with bioceramic gutta-percha..
- Who it may be relevant to
- Registry conditions: Dental Pain, Facial Swelling. Basic parameters: 20 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Evaluation of Obturation Using Bioceramic Nano-coated Gutta-percha and Bioceramic-based Sealer Versus Gutta-percha and Resin-based Sealer on Postoperative Pain and Swelling: A Randomized Clinical Trial.
Overview
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.
Detailed description
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.
Interventions
- Procedure Resin sealer with conventional gutta percha.
It is the gold standard obturation technique which will be used as the control group. - Procedure Bioceramic sealer with bioceramic gutta-percha.
Bioceramic sealer and bioceramic gutta-percha creating a monoblock for obturation of root canals.
Primary outcome measures
- Postoperative pain assessed by using a 10 cm Visual Analogue Scale. [Time frame: 48 hours]
Secondary outcome measures (1)
- Postoperative swelling assessed by using a 4 point Numerical Rating Scale. [Time frame: 48 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Out patient clinic Faculty of Dentistry Cairo University — Cairo
Publications
- 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. PMID 35735776
- 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. PMID 40361773
- 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. PMID 40746469
- 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.
- 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. PMID 40079999
- 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. PMID 38606520
- 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. PMID 31794999
- 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. PMID 29571915
Identifiers
NCT: NCT07600099 · CU-HT-Protocol