Decayed Primary Molars With Irreversible PulpitisNCT06751316
Clinical and Radiographic Evaluation of MTA Pulpotomy Versus Conventional Pulpectomy in Primary Molars With Irreversible Pulpitis
A study testing Conventional Pulpectomy and MTA Pulpotomy in people with Decayed Primary Molars With Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
This study is designed to compare between MTA Pulpotomy (Removal of coronal pulp tissue, placing MTA and covering with Stainless steel crown) Versus Conventional Pulpectomy (Removal of radicular pulp tissue, placing Zinc Oxide/Eugenol and covering with Stainless steel crown) in irreversible pulpitis in primary second… Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Decayed Primary Molars With Irreversible Pulpitis
- What is being tested?
- Conventional Pulpectomy and MTA Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jan 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients:
- Aged 4-7 years, cooperative, in good general health and medically within normal
- Teeth:
- Restorable mandibular second primary molars.
- History of irreversible pulpitis.
- Preoperative radiograph:
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- Absence of periapical or inter-radicular radiolucency.
- Absence of widening of periodontal ligaments (PDL) space.
- Absence of internal or external root resorption.
Who cannot join
- Patients:
- With systemic disorders.
- Physical or mental disabilities.
- Unable to attend follow- up visits.
- Refusal of Participation.
- Refusal to sign the informed consent.
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- Teeth:
- Previously accessed teeth.
- Mobile mandibular second primary molar.
- Swelling in the vestibule or on palpation.
- Pain on percussion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Radiographic Evaluation of MTA Pulpotomy Versus Conventional Pulpectomy in Primary Molars With Irreversible Pulpitis: A Randomized Clinical Trial
This study is designed to compare between MTA Pulpotomy (Removal of coronal pulp tissue, placing MTA and covering with Stainless steel crown) Versus Conventional Pulpectomy (Removal of radicular pulp tissue, placing Zinc Oxide/Eugenol and covering with Stainless steel crown) in irreversible pulpitis in primary second molars.
- Being tested
- Conventional Pulpectomy, MTA Pulpotomy
- Keywords
- MTA pulpotomy, Pulpectomy, Decayed primary molars, Irreversible pulpitits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PulpectomyProcedure or surgery
Removal of radicular pulp tissue, placing Zinc Oxide/Eugenol and covered by stainless steel crown
MTA PulpotomyProcedure or surgery
Removal of coronal pulp tissue, placing MTA and covered by stainless steel crown
| Study group | Role | What they receive |
|---|---|---|
| Conventional Pulpectomy | Experimental | Conventional pulpectomy using Zinc Oxide/Eugenol Receives: Procedure: Conventional Pulpectomy |
| MTA Pulpotomy | Experimental | Pulpotomy using MTA Receives: Procedure: MTA Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
• rate of clinical success
- tenderness on percussion and palpation
- sinus/parulis/fistula
- soft tissue swelling
- pathological mobility
Measured: 12 months
Secondary outcomes (1)
• rate of radiographic success
- pathologic root resorption.
- interradicular and/or periapical radiolucency
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 posted27 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decayed Primary Molars With Irreversible PulpitisStudies 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
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeyad Nasr Abdelhafeiz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751316
- Sponsor's protocol ID
- Pulpotomy Versus Pulpectomy
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of MTA Pulpotomy Versus Conventional Pulpectomy in Primary Molars With Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06751316
- Acronym / sponsor ID
- Pulpotomy Versus Pulpectomy
- Keywords
- MTA pulpotomy, Pulpectomy, Decayed primary molars, Irreversible pulpitits
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 27 Dec 2024 (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.
This study is designed to compare between MTA Pulpotomy (Removal of coronal pulp tissue, placing MTA and covering with Stainless steel crown) Versus Conventional Pulpectomy (Removal of radicular pulp tissue, placing Zinc Oxide/Eugenol and covering with Stainless steel crown) in irreversible pulpitis in primary second molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Pulpectomy | Experimental | Procedure: Conventional PulpectomyConventional pulpectomy using Zinc Oxide/Eugenol |
| MTA Pulpotomy | Experimental | Procedure: MTA PulpotomyPulpotomy using MTA |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patients:
- Aged 4-7 years, cooperative, in good general health and medically within normal
- Teeth:
- Restorable mandibular second primary molars.
- History of irreversible pulpitis.
Key exclusion criteria (11 listed)
- Patients:
- With systemic disorders.
- Physical or mental disabilities.
- Unable to attend follow- up visits.
- Refusal of Participation.
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 |
|---|---|---|
| Conventional PulpectomyRemoval of radicular pulp tissue, placing Zinc Oxide/Eugenol and covered by stainless steel crown | Procedure or surgery | Conventional Pulpectomy |
| MTA PulpotomyRemoval of coronal pulp tissue, placing MTA and covered by stainless steel crown | Procedure or surgery | MTA Pulpotomy |
Primary outcome
• rate of clinical success
Time frame: 12 months
* tenderness on percussion and palpation * sinus/parulis/fistula * soft tissue swelling * pathological mobility
1 secondary outcome
• rate of radiographic success
Time frame: 12 months
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 27 Dec 2024.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Pulpectomy and MTA Pulpotomy in people with Decayed Primary Molars With Irreversible Pulpitis, 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 9 inclusion and 11 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 27 Dec 2024. 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?
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?
• rate of clinical success (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 27 Dec 2024.