An interventional study of Resin sealer with conventional gutta percha. and Bioceramic sealer with bioceramic gutta-percha. in Dental Pain and Facial Swelling, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
Root canal obturation using resin-based sealer with conventional gutta-percha.
Procedure: Resin sealer with conventional gutta percha.
Root canal obturation using bioceramic sealer with bioceramic coated gutta-percha.
Procedure: Bioceramic sealer with bioceramic gutta-percha.
It is the gold standard obturation technique which will be used as the control group.
Bioceramic sealer and bioceramic gutta-percha creating a monoblock for obturation of root canals.
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.
Time frame: 48 hours
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.
Time frame: 48 hours
Plan to share: Yes — Age, Sex, Postoperative pain measurements, Postoperative swelling measurements, follow ups and radiographs.
Supporting information: Study protocol, Sap, Icf
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Cairo University