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.

NCT07600099 | Not Yet Recruiting DMC

• 1 other identifier: CU-HT-Protocol
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Pain; Facial Swelling

Keywords

bioceramic; monoblock

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Postoperative swelling assessed by using a 4 point Numerical Rating Scale.

  48 hours

Study Arms (2)

Conventional obturation group.

ACTIVE COMPARATOR

Root canal obturation using resin-based sealer with conventional gutta-percha.

Procedure: Resin sealer with conventional gutta percha.

Bioceramic obturation group.

EXPERIMENTAL

Root canal obturation using bioceramic sealer with bioceramic coated gutta-percha.

Procedure: Bioceramic sealer with bioceramic gutta-percha.

Interventions

Resin sealer with conventional gutta percha. PROCEDURE

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

Conventional obturation group.

Bioceramic sealer with bioceramic gutta-percha. PROCEDURE

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

Bioceramic obturation group.

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Out patient clinic Faculty of Dentistry Cairo University

Cairo, Cairo Governorate, Egypt

Location

Related Publications (10)

• 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 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.

  PMID: 40361773 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.

  PMID: 40746469 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.

  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.

  PMID: 40079999 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.

  PMID: 38606520 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.

  PMID: 31794999 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.

  PMID: 29571915 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.

  PMID: 40948576 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.

  BACKGROUND

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ghada Ehab ElWazzan, Lecturer

  Cairo University

  STUDY DIRECTOR

• Alaa ElBaz, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Hussein M Taha

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Biostatician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree Candidate

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Approximate start date will be at the end quarter of the year 2027.
• Access Criteria: Data will be available upon reasonable request to the principal investigator after publication of the study results.

Locations

EG (1)