Dental PainNCT07600099
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.
A study testing Resin sealer with conventional gutta percha. and Bioceramic sealer with bioceramic gutta-percha. in people with Dental Pain and Facial Swelling, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pain, Facial Swelling
- What is being tested?
- Resin sealer with conventional gutta percha. and Bioceramic sealer with bioceramic gutta-percha.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Out patient clinic Faculty of Dentistry Cairo University
Cairo, Cairo Governorate
About this study
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.
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.
Read the 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.
- Conditions
- Dental Pain, Facial Swelling
- Being tested
- Resin sealer with conventional gutta percha., Bioceramic sealer with bioceramic gutta-percha.
- Keywords
- bioceramic, monoblock
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin sealer with conventional gutta percha.Procedure or surgery
It is the gold standard obturation technique which will be used as the control group.
Bioceramic sealer with bioceramic gutta-percha.Procedure or surgery
Bioceramic sealer and bioceramic gutta-percha creating a monoblock for obturation of root canals.
| Study group | Role | What they receive |
|---|---|---|
| Conventional obturation group. | Active comparator | Root canal obturation using resin-based sealer with conventional gutta-percha. Receives: Procedure: Resin sealer with conventional gutta percha. |
| Bioceramic obturation group. | Experimental | Root canal obturation using bioceramic sealer with bioceramic coated gutta-percha. Receives: Procedure: Bioceramic sealer with bioceramic gutta-percha. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Secondary outcomes (1)
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Dental PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Taha, Cairo University
- Investigators
- Ghada Ehab ElWazzan, Lecturer, Study director, Cairo UniversityAlaa ElBaz, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600099
- Sponsor's protocol ID
- CU-HT-Protocol
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Age, Sex, Postoperative pain measurements, Postoperative swelling measurements, follow ups and radiographs.
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.
PubMed 35735776Alghamdi 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.
PubMed 40361773Swetha 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.
PubMed 40746469Somolová 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.
PubMed 40079999Zamparini 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.
PubMed 38606520Fonseca 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.
PubMed 31794999Graunaite 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.
PubMed 29571915Elmsmari 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.
PubMed 40948576Abou-Elnaga MY, Refai AS, Alkhawas MA. Post operative pain and swelling evaluation following guided endodontic microsurgeries done using different treatment modalities: a clinical study.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07600099
- Acronym / sponsor ID
- CU-HT-Protocol
- Conditions
- Dental Pain, Facial Swelling
- Keywords
- bioceramic, monoblock
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional obturation group. | Active comparator | Procedure: Resin sealer with conventional gutta percha.Root canal obturation using resin-based sealer with conventional gutta-percha. |
| Bioceramic obturation group. | Experimental | Procedure: Bioceramic sealer with bioceramic gutta-percha.Root canal obturation using bioceramic sealer with bioceramic coated gutta-percha. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resin sealer with conventional gutta percha.It is the gold standard obturation technique which will be used as the control group. | Procedure or surgery | Conventional obturation group. |
| Bioceramic sealer with bioceramic gutta-percha.Bioceramic sealer and bioceramic gutta-percha creating a monoblock for obturation of root canals. | Procedure or surgery | Bioceramic obturation group. |
Primary outcome
Postoperative pain assessed by using a 10 cm Visual Analogue Scale.
Time frame: 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.
1 secondary outcome
Postoperative swelling assessed by using a 4 point Numerical Rating Scale.
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 35735776Pirani 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.
- Background: PubMed 40361773Alghamdi 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.
- Background: PubMed 40746469Swetha 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.
- BackgroundSomolová 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: PubMed 40079999Rao 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.
- Background: PubMed 38606520Zamparini 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.
- Background: PubMed 31794999Fonseca 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.
- Background: PubMed 29571915Graunaite 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.
- Background: PubMed 40948576Elmsmari 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.
- BackgroundAbou-Elnaga MY, Refai AS, Alkhawas MA. Post operative pain and swelling evaluation following guided endodontic microsurgeries done using different treatment modalities: a clinical study.
- Individual participant dataSharing planned: Yes. Age, Sex, Postoperative pain measurements, Postoperative swelling measurements, follow ups and radiographs.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ghada Ehab ElWazzan, Lecturer study director
Cairo University
Alaa ElBaz, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin sealer with conventional gutta percha. and Bioceramic sealer with bioceramic gutta-percha. in people with Dental Pain and Facial Swelling, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hussein M Taha (+201004421891, hussein.mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain assessed by using a 10 cm Visual Analogue Scale. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07600099, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.