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.

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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07600099

Enrollment

Registered

2026-05-20

Start date

2026-09-01

Completion date

2027-09-30

Last updated

2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pain, Facial Swelling

Keywords

bioceramic, monoblock

Brief summary

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

PROCEDUREResin sealer with conventional gutta percha.

It is the gold standard obturation technique which will be used as the control group.

PROCEDUREBioceramic sealer with bioceramic gutta-percha.

Bioceramic sealer and bioceramic gutta-percha creating a monoblock for obturation of root canals.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Biostatician

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain assessed by using a 10 cm Visual Analogue Scale.	48 hours	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.

Secondary

Measure	Time frame	Description
Postoperative swelling assessed by using a 4 point Numerical Rating Scale.	48 hours	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.

Countries

Egypt

Contacts

CONTACTHussein M Taha

hussein.mohamed@dentistry.cu.edu.eg+201004421891

STUDY_DIRECTORGhada Ehab ElWazzan, Lecturer

Cairo University

STUDY_DIRECTORAlaa ElBaz, Professor