Pulpitis - IrreversibleNCT06929247
Clinical and Radiographic Evaluation of Pulpotomy Using Neoputty MTA Versus Pulpectomy Using Metapex in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis in Children Aged 4 to 9 Years.
A study testing Pulpotomy using Neoputty Mineral Trioxide Aggregate and single visit pulpectomy using metapex in people with Pulpitis - Irreversible, run by Mohamed Nashaat Mohamed.
Trial summary
itle: Evaluation of Pulpotomy using Neoputty MTA vs. Pulpectomy using Metapex in Children (4-9 years). Objective: Compare clinical and radiographic success of pulpotomy vs. pulpectomy for vital primary molars with irreversible pulpitis. Design: Randomized controlled trial with 2-arm parallel groups. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Pulpotomy using Neoputty Mineral Trioxide Aggregate and single visit pulpectomy using metapex
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Apr 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Symptoms typical of irreversible pulpitis, such as spontaneous, unprovoked pain lasting from a few seconds to several hours prior to the dental visit, or pain exacerbated by hot and/or cold stimuli that lingers even after the stimuli are removed.
- 2. Confirmation of tooth vitality post-deroofing the pulp chamber, indicated by the presence of uniformly reddish-pink vascular tissue (healthy pulp) upon visual inspection of pulpal hemorrhage.
- 3. Confirmation of radicular pulp health post-coronal pulp amputation, demonstrated by achieving radicular pulp hemostasis within 8 minutes using a 5% sodium hypochlorite (NaOCl)-dampened cotton pellet.
- 4. The primary molar must be restorable with a stainless-steel crown. 5. Any physiological root resorption present must be less than one-third of the normal root length.
Who cannot join
- 1. Clinical signs of pulpal infection, such as pathologic tooth mobility, parulis/fistula, or soft tissue swelling.
- 2. Pre-operative periapical radiographs indicating furcal radiolucency extending more than half the distance from the furcation to the periapical area.
- 3. Pre-operative periapical radiographs showing periapical radiolucency. 4. Pre-operative periapical radiographs indicating pathological root resorption.
- 5. Signs of necrosis in pulp tissue post-deroofing, such as avascular or minimally bleeding pulp, or yellowish necrotic areas/purulent exudate.
- 6. Evidence of extensive radicular pulp inflammation post-coronal pulp amputation, indicated by bleeding that continues after 8 minutes of compression with a NaOCl-soaked cotton pellet.
- 7. Parents unwilling to place full coverage crowns post-treatment. 8. If both primary molars in the quadrant are painful and the clinical diagnosis of irreversible pulpitis between the teeth is not sharply defined.
About this study
Official title: Clinical and Radiographic Evaluation of Pulpotomy Using Neoputty MTA Versus Pulpectomy Using Metapex in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis in Children Aged 4 to 9 Years: A Randomized Controlled Trial
itle: Evaluation of Pulpotomy using Neoputty MTA vs. Pulpectomy using Metapex in Children (4-9 years).
Objective: Compare clinical and radiographic success of pulpotomy vs. pulpectomy for vital primary molars with irreversible pulpitis.
Design: Randomized controlled trial with 2-arm parallel groups.
Participants: Healthy children aged 4-9 with specific inclusion/exclusion criteria.
Outcomes: Primary (pain relief, absence of complications) and secondary (radiographic success).
Read the detailed description
Background and Rationale Treating irreversible pulpitis in primary molars is challenging due to complex root canal anatomy and rapid progression of pulp inflammation. Pulpectomy is the standard approach, but its technical difficulty often necessitates referral to specialists. New bioactive materials like Neoputty MTA and improved understanding of pulp biology justify reevaluation of less invasive treatments like pulpotomy. This study addresses the lack of clinical trials comparing pulpotomy with pulpectomy in cases of irreversible pulpitis in primary molars. Aim To compare the clinical and radiographic success of pulpotomy using Neoputty MTA vs. pulpectomy using Metapex in vital primary molars with symptomatic irreversible pulpitis in children aged 49 years. Hypothesis Null Hypothesis: No significant difference in treatment outcome between pulpotomy and pulpectomy.
Methodology Participants
- Setting: Pediatric Dentistry Department, Faculty of Dentistry, Cairo University
- Eligibility: Healthy (ASA I/II), cooperative children aged 49 with vital primary molars exhibiting signs of irreversible pulpitis.
- Exclusion: Necrotic pulp, periapical pathology, pathological mobility, poor restorability, or refusal of crown placement. Sample Size 40 teeth per group (total 80), accounting for 15% dropout. Based on expected 20% difference in outcomes and 80% power. Interventions Pulpotomy (Test Group): Removal of coronal pulp followed by Neoputty MTA placement and restoration. Pulpectomy (Control Group): Complete root canal debridement and obturation with Metapex. Same restoration and crown protocol. Outcomes Primary: Post-operative pain (VAS), clinical and radiographic success over 12 months.
Secondary: Pain assessment at 24 hours and 7 days post-treatment using VAS. Follow-up Timeline Evaluations at baseline, 24h, 1w, 3m, 6m, 9m, and 12m post-intervention. Randomization and Blinding Randomization via opaque sealed envelopes. Outcome assessors blinded.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Pulpotomy using Neoputty Mineral Trioxide Aggregate, single visit pulpectomy using metapex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpotomy using Neoputty Mineral Trioxide AggregateProcedure or surgery
Also called MTA
Pulpotomy (Test Group): Removal of coronal pulp followed by Neoputty MTA placement and restoration.
single visit pulpectomy using metapexProcedure or surgery
Also called calcium hydroxide with iodoform
pulpectomy: removal of radicular pulp followed by metapex placement and final restoration
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy | Experimental | Pulpotomy using Neoputty Mineral Trioxide Aggregate Receives: Procedure: Pulpotomy using Neoputty Mineral Trioxide Aggregate |
| pulpectomy | Active comparator | Single-visit pulpectomy using Metapex Receives: Procedure: single visit pulpectomy using metapex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
by Visual analog scale from zero to ten. which zero is better outcome and ten is worse outcome
Measured: after 24h , 1week, 3 months, 6 months ,9 months and 12 months
Secondary outcomes (5)
Pain on percussion
Tapping the tooth with the blunt end of the mirror
Measured: after 24h , 1week, 3 months, 6 months ,9 months and 12 months
Number of tooth with Swelling or fistula
Clinical examination
Measured: after 24h , 1week, 3 months, 6 months ,9 months and 12 months
Mobility
Clinical examination
Measured: after 24h , 1week, 3 months, 6 months ,9 months and 12 months
Radiolucency at the furcation or periapical area
Digital periapical intraoral radiograph
Measured: after 24h , 1week, 3 months, 6 months ,9 months and 12 months
Internal or external root resorption
Digital periapical intraoral radiograph
Measured: after 24h , 1week, 3 months, 6 months ,9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies 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
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Nashaat Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Nashaat Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929247
- Sponsor's protocol ID
- 20230730
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Pulpotomy Using Neoputty MTA Versus Pulpectomy Using Metapex in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis in Children Aged 4 to 9 Years: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06929247
- Acronym / sponsor ID
- 20230730
- Conditions
- Pulpitis - Irreversible
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mohamed Nashaat MohamedUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 16 Apr 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.
itle: Evaluation of Pulpotomy using Neoputty MTA vs. Pulpectomy using Metapex in Children (4-9 years).
Objective: Compare clinical and radiographic success of pulpotomy vs. pulpectomy for vital primary molars with irreversible pulpitis.
Design: Randomized controlled trial with 2-arm parallel groups.
Participants: Healthy children aged 4-9 with specific inclusion/exclusion criteria.
Outcomes: Primary (pain relief, absence of complications) and secondary (radiographic success).
Detailed description
Background and Rationale Treating irreversible pulpitis in primary molars is challenging due to complex root canal anatomy and rapid progression of pulp inflammation. Pulpectomy is the standard approach, but its technical difficulty often necessitates referral to specialists. New bioactive materials like Neoputty MTA and improved understanding of pulp biology justify reevaluation of less invasive treatments like pulpotomy. This study addresses the lack of clinical trials comparing pulpotomy with pulpectomy in cases of irreversible pulpitis in primary molars. Aim To compare the clinical and radiographic success of pulpotomy using Neoputty MTA vs. pulpectomy using Metapex in vital primary molars with symptomatic irreversible pulpitis in children aged 49 years. Hypothesis Null Hypothesis: No significant difference in treatment outcome between pulpotomy and pulpectomy.
Methodology Participants
- Setting: Pediatric Dentistry Department, Faculty of Dentistry, Cairo University
- Eligibility: Healthy (ASA I/II), cooperative children aged 49 with vital primary molars exhibiting signs of irreversible pulpitis.
- Exclusion: Necrotic pulp, periapical pathology, pathological mobility, poor restorability, or refusal of crown placement. Sample Size 40 teeth per group (total 80), accounting for 15% dropout. Based on expected 20% difference in outcomes and 80% power. Interventions Pulpotomy (Test Group): Removal of coronal pulp followed by Neoputty MTA placement and restoration. Pulpectomy (Control Group): Complete root canal debridement and obturation with Metapex. Same restoration and crown protocol. Outcomes Primary: Post-operative pain (VAS), clinical and radiographic success over 12 months.
Secondary: Pain assessment at 24 hours and 7 days post-treatment using VAS. Follow-up Timeline Evaluations at baseline, 24h, 1w, 3m, 6m, 9m, and 12m post-intervention. Randomization and Blinding Randomization via opaque sealed envelopes. Outcome assessors blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy | Experimental | Procedure: Pulpotomy using Neoputty Mineral Trioxide AggregatePulpotomy using Neoputty Mineral Trioxide Aggregate |
| pulpectomy | Active comparator | Procedure: single visit pulpectomy using metapexSingle-visit pulpectomy using Metapex |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1. Symptoms typical of irreversible pulpitis, such as spontaneous, unprovoked pain lasting from a few seconds to several hours prior to the dental visit, or pain exacerbated by hot and/or cold stimuli that lingers even after the stimuli are removed.
- 2. Confirmation of tooth vitality post-deroofing the pulp chamber, indicated by the presence of uniformly reddish-pink vascular tissue (healthy pulp) upon visual inspection of pulpal hemorrhage.
- 3. Confirmation of radicular pulp health post-coronal pulp amputation, demonstrated by achieving radicular pulp hemostasis within 8 minutes using a 5% sodium hypochlorite (NaOCl)-dampened cotton pellet.
- 4. The primary molar must be restorable with a stainless-steel crown. 5. Any physiological root resorption present must be less than one-third of the normal root length.
Key exclusion criteria (6 listed)
- 1. Clinical signs of pulpal infection, such as pathologic tooth mobility, parulis/fistula, or soft tissue swelling.
- 2. Pre-operative periapical radiographs indicating furcal radiolucency extending more than half the distance from the furcation to the periapical area.
- 3. Pre-operative periapical radiographs showing periapical radiolucency. 4. Pre-operative periapical radiographs indicating pathological root resorption.
- 5. Signs of necrosis in pulp tissue post-deroofing, such as avascular or minimally bleeding pulp, or yellowish necrotic areas/purulent exudate.
- 6. Evidence of extensive radicular pulp inflammation post-coronal pulp amputation, indicated by bleeding that continues after 8 minutes of compression with a NaOCl-soaked cotton pellet.
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 using Neoputty Mineral Trioxide AggregateAlso: MTAPulpotomy (Test Group): Removal of coronal pulp followed by Neoputty MTA placement and restoration. | Procedure or surgery | Pulpotomy |
| single visit pulpectomy using metapexAlso: calcium hydroxide with iodoformpulpectomy: removal of radicular pulp followed by metapex placement and final restoration | Procedure or surgery | pulpectomy |
Primary outcome
Post-operative pain
Time frame: after 24h , 1week, 3 months, 6 months ,9 months and 12 months
by Visual analog scale from zero to ten. which zero is better outcome and ten is worse outcome
5 secondary outcomes
Pain on percussion
Time frame: after 24h , 1week, 3 months, 6 months ,9 months and 12 months
Number of tooth with Swelling or fistula
Time frame: after 24h , 1week, 3 months, 6 months ,9 months and 12 months
Mobility
Time frame: after 24h , 1week, 3 months, 6 months ,9 months and 12 months
Radiolucency at the furcation or periapical area
Time frame: after 24h , 1week, 3 months, 6 months ,9 months and 12 months
Internal or external root resorption
Time frame: after 24h , 1week, 3 months, 6 months ,9 months and 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 16 Apr 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 using Neoputty Mineral Trioxide Aggregate and single visit pulpectomy using metapex in people with Pulpitis - Irreversible, run by Mohamed Nashaat Mohamed.
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 4 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: opening soon, as of the sponsor's last update on 16 Apr 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?
Post-operative pain (time frame: after 24h , 1week, 3 months, 6 months ,9 months and 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 16 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.