PulpectomyPhase 4NCT07772986
Bioceramic Sealer as an Obturation Material in Retained Primary Molars
A Phase 4 study testing bioceramic sealer in people with Pulpectomy and Bioceramic Sealer, run by Osama Seif El-Nasr Hussein Gad El-Hak at 1 site in Egypt.
Trial summary
The goal of this single arm clinical trial was to to explore the clinical feasibility and radiographic outcome of the injectable bioceramic sealer as an obturation material for primary molars with congenitally missing permanent successors. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Pulpectomy, Bioceramic Sealer
- What is being tested?
- bioceramic sealer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2023to 24 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy (ASA I or II) children.
- Cooperative (Frankel behavior rating 3 or 4) children
- children having at least one mandibular primary 2nd molar with deep carious lesion.
- No radiographic evidence of the developing permanent successor on orthopantomogram.
- Signs and symptoms typical of irreversible pulpitis or pulp necrosis.
- patients with minimal crowding (1-3 mm) or perfect alignment according to the Little's Irregularity Index in the lower arch.
Who cannot join
- Non-restorable primary molars.
- Primary molars with severe infra-occlusion.
- Presence of iatrogenic or pathological perforation of the pulpal floor.
- Post-deroofing presence of healthy vital pulp, presenting as uniformly reddish pink vascular tissue.
- Preoperative radiograph showing signs of internal or external pathological root resorption.
- Root canal calcification.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Outcomes of Bioceramic Sealer as an Obturation Material in Primary Molars With Congenitally Missing Permanent Successors: A Prospective Single-Arm Feasibility Study
The goal of this single arm clinical trial was to to explore the clinical feasibility and radiographic outcome of the injectable bioceramic sealer as an obturation material for primary molars with congenitally missing permanent successors. The main question it aimed to answer was:
Does injectable bioceramic sealers can be used as an obturation material for primary molars with congenitally missing permanent successors?
Read more
Researchers used a commercially available bioceramic sealer as a sole obturation material for pulpectomized primary molars with congenitally missing permanent successors
Eligible participants underwent pulpectomy treatment and followed up at 3,6,12 and 24 months postoperatively to evaluate clinical and radiographic success.
- Conditions
- Pulpectomy, Bioceramic Sealer
- Being tested
- bioceramic sealer
- Keywords
- pulpectomy, retained primary molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioceramic sealerBiological
Also called Ceraseal
the root canals were obturated solely with Ceraseal bioceramic sealer
| Study group | Role | What they receive |
|---|---|---|
| Bioceramic sealer obturation | Experimental | a single arm study in which eligible participants underwent obturation by a bioceramic sealer material for their pulpectomized molars Receives: Biological: bioceramic sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with clinically successful treatment (Asymptomatic teeth)
- The tooth is asymptomatic, with no pain or discomfort.
- Absence of tenderness upon percussion or palpation.
- No evidence of pathological tooth mobility, soft tissue swelling, sinus tract formation, or purulent discharge from the gingival margin.
Measured: 3 months postoperatively, 6 months postoperatively, 12 months postoperatively, 24 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start15 Mar 2023
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpectomyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osama Seif El-Nasr Hussein Gad El-Hak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Osama Seif El-Nasr Hussein Gad El-Hak, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772986
- Sponsor's protocol ID
- MYO2582
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Bioceramic Sealer as an Obturation Material in Primary Molars With Congenitally Missing Permanent Successors: A Prospective Single-Arm Feasibility Study
- ClinicalTrials.gov ID
- NCT07772986
- Acronym / sponsor ID
- MYO2582
- Conditions
- Pulpectomy, Bioceramic Sealer
- Keywords
- pulpectomy, retained primary molars
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Osama Seif El-Nasr Hussein Gad El-HakUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 19 Aug 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.
The goal of this single arm clinical trial was to to explore the clinical feasibility and radiographic outcome of the injectable bioceramic sealer as an obturation material for primary molars with congenitally missing permanent successors. The main question it aimed to answer was:
Does injectable bioceramic sealers can be used as an obturation material for primary molars with congenitally missing permanent successors?
Researchers used a commercially available bioceramic sealer as a sole obturation material for pulpectomized primary molars with congenitally missing permanent successors
Eligible participants underwent pulpectomy treatment and followed up at 3,6,12 and 24 months postoperatively to evaluate clinical and radiographic success.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioceramic sealer obturation | Experimental | Biological: bioceramic sealera single arm study in which eligible participants underwent obturation by a bioceramic sealer material for their pulpectomized molars |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy (ASA I or II) children.
- Cooperative (Frankel behavior rating 3 or 4) children
- children having at least one mandibular primary 2nd molar with deep carious lesion.
- No radiographic evidence of the developing permanent successor on orthopantomogram.
- Signs and symptoms typical of irreversible pulpitis or pulp necrosis.
Key exclusion criteria (6 listed)
- Non-restorable primary molars.
- Primary molars with severe infra-occlusion.
- Presence of iatrogenic or pathological perforation of the pulpal floor.
- Post-deroofing presence of healthy vital pulp, presenting as uniformly reddish pink vascular tissue.
- Preoperative radiograph showing signs of internal or external pathological root resorption.
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 |
|---|---|---|
| bioceramic sealerAlso: Cerasealthe root canals were obturated solely with Ceraseal bioceramic sealer | Biological | Bioceramic sealer obturation |
Primary outcome
number of participants with clinically successful treatment (Asymptomatic teeth)
Time frame: 3 months postoperatively, 6 months postoperatively, 12 months postoperatively, 24 months postoperatively.
* The tooth is asymptomatic, with no pain or discomfort. * Absence of tenderness upon percussion or palpation. * No evidence of pathological tooth mobility, soft tissue swelling, sinus tract formation, or purulent discharge from the gingival margin.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pulpectomy
Recruiting
Clinical and Radiographic Evaluation of E-IodoCal in Primary Molar Pulpectomy
Pulpectomy, Pulpitis - Irreversible
Not yet recruiting
Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy
Pulpectomy
Not yet recruitingEarly Phase 1
Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) for Emergency Dental Treatment in Public Health Settings: A Randomized Trial
Pulp Disease, Dental, Pulp Necrosis
Recruiting
Evaluation of Zinc Oxide Eugenol and Iodoform-Calcium Hydroxide as Filling Materials in Primary Molar Root Canals Prepared by Rotary and Manual Files
Carious Primary Molars Indicated for Pulpectomy
Not yet recruiting
Clinical and Radiographic Outcomes of Rotary Instrumentation in Primary Molars
Pulpectomy, Irreversible Pulpitis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bioceramic sealer in people with Pulpectomy and Bioceramic Sealer, run by Osama Seif El-Nasr Hussein Gad El-Hak 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 20 Aug 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with clinically successful treatment (Asymptomatic teeth) (time frame: 3 months postoperatively, 6 months postoperatively, 12 months postoperatively, 24 months postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026; AzTrials last refreshed its copy on 4 Nov 2026.