Irreversible Pulpitis (Toothache)NCT07046533
Evaluation of the Success Rate of Pulpotomy Versus to Root Canal Therapy in Management of Mature First Permanent Molars With Irreversible Pulpitis
A study testing (pulpotomy) and root canal treatment in people with Irreversible Pulpitis (Toothache) and Dental Caries (Diagnosis), run by Lamiaa Saeed Ahmed Elshiekh.
Trial summary
The goal of This current study compare the clinical \& radiographic success rate between two different modalities conventional RCT and VPT using Bio-C-Repair as a pulp capping material to treat young patients with mature first permanent molars with irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 9 to 14 months
- Conditions the study is for
- Irreversible Pulpitis (Toothache), Dental Caries (Diagnosis)
- What is being tested?
- (pulpotomy) and root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jul 2026
- 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 9 to 14 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Molars teeth with a history of spontaneous radiating pain indicated IP
- the pain triggered by hot/cold fluids lasted for several minutes after removing of the stimulus.
- Molars teeth with no prominent radiolucency at the periapical or furcation regions
Who cannot join
- Teeth with continuous bleeding
- necrosis
- Teeth could not be restored with direct restoration. Teeth having localized/generalized periodontal diseases (probing pocket depth more than 3 mm).
- Teeth with crack fracture. Teeth with internal/external root resorption. Teeth with pulp chamber/canal calcification
About this study
Official title: Evaluation of the Success Rate of Full Coronal Pulpotomy as Compared to Conventional Root Canal Therapy in the Management of Mature First Permanent Molars With Irreversible Pulpitis in Children
The goal of This current study compare the clinical \& radiographic success rate between two different modalities conventional RCT and VPT using Bio-C-Repair as a pulp capping material to treat young patients with mature first permanent molars with irreversible pulpitis.
Read the detailed description
The teeth were anesthetized with 4% articaine with adrenaline 1/100,000 , isolated under rubber dam , and sterilized using a cotton pellet soaked in 2.5% sodium hypochlorite (NaOCl). Then carious leisons were removed by using a fresh sterile high-speed diamond bur under copious water irrigation. Upon pulp exposed, the cavity was rinsed with 2.5% NaOCl. The other steps of the treatment proceeded accordingly:
The procedure FP involved the removal of all coronal pulp tissue to the canals orifices level through a fresh sterile high-speed diamond bur Hemostasis was accomplished by compressing a cotton pellet soaked in 2.5% NaOCl over the radicular pulp tissue for 5 min. Then, irrigation with amount of sterile 0.9% sodium chloride (NaCl) solution was gently conducted. Once hemostasis was achieved, the radicular pulp tissue was observed as uniformly reddish pink color. Subsequently, a new type of premixed pulp-capping bio c repair ) was prepared according to the manufacturer's instructions, and a 4-mm layer was directly adapted over the radicular pulp tissue, ensuring that there was not any excess materials on the pulp chamber walls. The access cavity was restored with a liner)and composite restoration all completed in a single visit. Then postoperative radiographs were taken.
RCT was conducted in single visit the pulp tissues were removed from all the root canals, identifying and enlarging canal orifices via fanta Gold rotary , determing the working length with an apex locator. The root canals preparation was conducted by rotary nickel-titanium files, irrigated by using 2.5% NaOCl and 17% ethylenediaminetetraacetic acid (EDTA), and disinfected by using Ca(OH)2.
obturation was performed with gutta-percha and biocermaic sealer, using single cone technique.The access cavity was restored with a liner and resin composite restoration during the same appointment while using rubber dam isolation.
- Being tested
- (pulpotomy), root canal treatment
- Keywords
- randomized control trial, vital pulp therapy
- Medical subject headings
- Toothache, Dental Caries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(pulpotomy)Procedure or surgery
Also called vital pulp therapy
non invasive technique depends on remove only the coronal pulp tissue instead of remove all pulp tissue
root canal treatmentProcedure or surgery
invasive technique depends on remove all radicular and coronal pulp tissue
| Study group | Role | What they receive |
|---|---|---|
| root canal treatment | Active comparator | invasive technique depends on removal of all pulp tissue coronal and radicular and restore it with a gutta perch with bioceramic sealer Receives: Procedure: (pulpotomy); Procedure: root canal treatment |
| pulpotomy | Experimental | non invasive technique depends on removal of only coronal pulp tissue and restore it with a new material bio c repair Receives: Procedure: (pulpotomy); Procedure: root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
clinically and radiographically success rate according to success criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible Pulpitis (Toothache)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lamiaa Saeed Ahmed Elshiekh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lamiaa Saeed Ahmed Elshiekh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046533
- Sponsor's protocol ID
- Cairo2007
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Success Rate of Full Coronal Pulpotomy as Compared to Conventional Root Canal Therapy in the Management of Mature First Permanent Molars With Irreversible Pulpitis in Children
- ClinicalTrials.gov ID
- NCT07046533
- Acronym / sponsor ID
- Cairo2007
- Keywords
- randomized control trial, vital pulp therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lamiaa Saeed Ahmed ElshiekhUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 1 Jul 2025 (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 current study compare the clinical \& radiographic success rate between two different modalities conventional RCT and VPT using Bio-C-Repair as a pulp capping material to treat young patients with mature first permanent molars with irreversible pulpitis.
Detailed description
The teeth were anesthetized with 4% articaine with adrenaline 1/100,000 , isolated under rubber dam , and sterilized using a cotton pellet soaked in 2.5% sodium hypochlorite (NaOCl). Then carious leisons were removed by using a fresh sterile high-speed diamond bur under copious water irrigation. Upon pulp exposed, the cavity was rinsed with 2.5% NaOCl. The other steps of the treatment proceeded accordingly:
The procedure FP involved the removal of all coronal pulp tissue to the canals orifices level through a fresh sterile high-speed diamond bur Hemostasis was accomplished by compressing a cotton pellet soaked in 2.5% NaOCl over the radicular pulp tissue for 5 min. Then, irrigation with amount of sterile 0.9% sodium chloride (NaCl) solution was gently conducted. Once hemostasis was achieved, the radicular pulp tissue was observed as uniformly reddish pink color. Subsequently, a new type of premixed pulp-capping bio c repair ) was prepared according to the manufacturer's instructions, and a 4-mm layer was directly adapted over the radicular pulp tissue, ensuring that there was not any excess materials on the pulp chamber walls. The access cavity was restored with a liner)and composite restoration all completed in a single visit. Then postoperative radiographs were taken.
RCT was conducted in single visit the pulp tissues were removed from all the root canals, identifying and enlarging canal orifices via fanta Gold rotary , determing the working length with an apex locator. The root canals preparation was conducted by rotary nickel-titanium files, irrigated by using 2.5% NaOCl and 17% ethylenediaminetetraacetic acid (EDTA), and disinfected by using Ca(OH)2.
obturation was performed with gutta-percha and biocermaic sealer, using single cone technique.The access cavity was restored with a liner and resin composite restoration during the same appointment while using rubber dam isolation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| root canal treatment | Active comparator | Procedure: (pulpotomy), Procedure: root canal treatmentinvasive technique depends on removal of all pulp tissue coronal and radicular and restore it with a gutta perch with bioceramic sealer |
| pulpotomy | Experimental | Procedure: (pulpotomy), Procedure: root canal treatmentnon invasive technique depends on removal of only coronal pulp tissue and restore it with a new material bio c repair |
Who may qualify
- Ages
- 9 to 14 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Molars teeth with a history of spontaneous radiating pain indicated IP
- the pain triggered by hot/cold fluids lasted for several minutes after removing of the stimulus.
- Molars teeth with no prominent radiolucency at the periapical or furcation regions
Key exclusion criteria (4 listed)
- Teeth with continuous bleeding
- necrosis
- Teeth could not be restored with direct restoration. Teeth having localized/generalized periodontal diseases (probing pocket depth more than 3 mm).
- Teeth with crack fracture. Teeth with internal/external root resorption. Teeth with pulp chamber/canal calcification
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 |
|---|---|---|
| (pulpotomy)Also: vital pulp therapynon invasive technique depends on remove only the coronal pulp tissue instead of remove all pulp tissue | Procedure or surgery | pulpotomy, root canal treatment |
| root canal treatmentinvasive technique depends on remove all radicular and coronal pulp tissue | Procedure or surgery | pulpotomy, root canal treatment |
Primary outcome
success rate
Time frame: 12 months
clinically and radiographically success rate according to success criteria
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 1 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing (pulpotomy) and root canal treatment in people with Irreversible Pulpitis (Toothache) and Dental Caries (Diagnosis), run by Lamiaa Saeed Ahmed Elshiekh.
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 4 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 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
success rate (time frame: 12 months). 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 1 Jul 2025.