Pulp TherapyNCT07230717
Evaluation of Pulpotomy Versus Pulpectomy in Primary Molars With Irreversible Pulpitis or Necrotic Pulp
A study testing Pulpotomy and Pulpectomy in people with Pulp Therapy and Pulpitis - Irreversible, run by Ajman University.
Trial summary
Preserving primary teeth until their normal exfoliation time is crucial for maintaining the child's normal function, esthetics, arch integrity, and correct eruption of permanent successors. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Therapy, Pulpitis - Irreversible, Pulp Necrosis
- What is being tested?
- Pulpotomy and Pulpectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 May 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients in healthy medical conditions
- Bilateral/contralateral primary molars diagnosed with irreversible pulpitis or necrotic pulp
- Periapical or bifurcation radiolucency
- Chronic apical intraoral abscess
- Sinus tract or fistula formation
- No tooth mobility or grade I mobility
- External root resorption less than or equal to 1/3rd of the roots
- Tooth should be restorable
Who cannot join
- Patients who are medically compromised (with systemic conditions)
- Acute extraoral abscess
- Grade II or III tooth mobility
- External root resorption in more than 1/3 of roots
- Physiological root resorption of more than 1/3 of the roots or near exfoliation
- Non-restorable teeth
About this study
Official title: Clinical and Radiographic Evaluation of Pulpotomy Versus Pulpectomy in Primary Molars With Irreversible Pulpitis or Necrotic Pulp: A Split-Mouth Randomized Clinical Trial
Preserving primary teeth until their normal exfoliation time is crucial for maintaining the child's normal function, esthetics, arch integrity, and correct eruption of permanent successors. Given the growing interest in conservative procedures and the clinical need for simpler, more predictable pulp therapy outcomes in children, evaluating pulpotomy with Pulpotec as a potential alternative to pulpectomy is essential.
The aim of this study is to evaluate the clinical and radiographic success of pulpotomy using Pulpotec versus pulpectomy using Metapex, a calcium hydroxide with iodoform paste, to treat primary molars in children diagnosed with irreversible pulpitis or necrotic pulp in the Postgraduate Pediatric Dental Clinic at Ajman University, UAE. A total of 25 contralateral paired molar samples from children aged 4 to 8 will be included in this split-mouth randomized controlled study. Each child will serve as their own control, with one tooth randomized to the intervention group (Pulpotomy using Pulpotec) and the other to the control group (Pulpectomy using Metapex) to assess patients' clinical and radiographic outcomes over a 12-month follow-up period. Patients will have their dental anxiety psychometrically assessed using the RMS pictorial scale. In addition, a pulse oximeter will be used as a biological marker in the study to measure oxygen saturation and pulse rate.
Read the detailed description
With increasing emphasis on conservative and predictable pulp therapy in pediatric dentistry, this study aims to evaluate pulpotomy using Pulpotec as a potential alternative to pulpectomy using Metapex in the management of primary molars with irreversible pulpitis or necrotic pulp.
This split-mouth randomized controlled clinical trial will include 25 children aged 4-8 years attending the Postgraduate Pediatric Dental Clinic at Ajman University, UAE. Each participant will contribute two contralateral primary molars-one assigned to the intervention group (Pulpotomy with Pulpotec) and the other to the control group (Pulpectomy with Metapex, a calcium hydroxide and iodoform paste).
The outcome will assess and compare the clinical and radiographic success rates of pulpotomy and pulpectomy procedures performed in primary molars diagnosed with irreversible pulpitis or necrotic pulp. Clinical success will be defined by the absence of pain, swelling, sinus tract, mobility, or tenderness to percussion. Radiographic success will be defined by the absence of periapical or inter-radicular radiolucency, internal or external resorption, and evidence of continued root resorption consistent with normal exfoliation. In addition, dental anxiety will be assessed using the RMS Pictorial Anxiety Scale, and physiological parameters such as pulse rate (beats/min) and oxygen saturation (SpO₂, %) will be recorded using a pulse oximeter to explore potential correlations between anxiety and treatment response.
- Conditions
- Pulp Therapy, Pulpitis - Irreversible, Pulp Necrosis
- Being tested
- Pulpotomy, Pulpectomy
- Keywords
- Pulpotomy, Pulpectomy, primary molars, irreversible pulpitis, necrotic pulp
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
Pulpotomy with pulpotec Powder: (iodoform, polyoxymethylene, excipient) and a Liquid: (dexamethasone acetate, formaldehyde, phenol, guaiacol, excipient) mixed into a paste consistency as per manufacturer instruction.
Pulpectomy with metapex Content: Calcium Hydroxide, Iodoform, Silicon oil
PulpectomyProcedure or surgery
Calcium Hydroxide, Iodoform, Silicon oil
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy | Experimental | Pulpotomy Receives: Procedure: Pulpotomy |
| Pulpectomy | Active comparator | Pulpectomy Receives: Procedure: Pulpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographic success rates of pulpotomy versus pulpectomy in primary molars of children with irreversible pulpitis or necrotic pulp over a 12-month follow-up period
The outcome will assess and compare the clinical and radiographic success rates of pulpotomy and pulpectomy procedures performed in primary molars diagnosed with irreversible pulpitis or necrotic pulp. Clinical success will be defined by the absence of pain, swelling, sinus tract, mobility, or tenderness to percussion. Radiographic success will be defined by the absence of periapical or inter-radicular radiolucency, internal or external resorption, and evidence of continued root resorption consistent with normal exfoliation.
Measured: 3 months, 6 months, 9 months, and 12 months follow up post-treatment.
Secondary outcomes (3)
Anxiety Level using RMS Pictorial Scale
Anxiety will be assessed using the Raghavendra Madhuri Sujata (RMS) Pictorial Scale, a validated visual scale designed to measure dental anxiety in children. Scores range from 1 to 5, where a higher score indicates a greater level of anxiety.
Measured: Baseline (in the waiting area before entering the operatory), Pre-operative (immediately before the start of the procedure), Operative (during the dental treatment), and Post-operative (immediately after completion of the procedure).
Pulse Rate in beats per minute (bpm) using Pulse Oximeter
Pulse rate will be measured in beats per minute (bpm) using a calibrated digital pulse oximeter to assess the physiological response to anxiety during dental treatment.
Measured: Baseline (in the waiting area before entering the operatory), Pre-operative (immediately before the start of the procedure), Operative (during the dental treatment), and Post-operative (immediately after completion of the procedure).
Oxygen Saturation (SpO₂) in percentage (%) using Pulse Oximeter
Oxygen saturation (SpO₂) will be measured in percentage (%) using a calibrated digital pulse oximeter to assess physiological changes associated with anxiety during dental treatment.
Measured: Baseline (in the waiting area before entering the operatory), Pre-operative (immediately before the start of the procedure), Operative (during the dental treatment), and Post-operative (immediately after completion of the procedure).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp TherapyStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Raghavendra Shetty, Ajman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230717
- Sponsor's protocol ID
- D-S-H-22-Jun
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2025
- Last updated
- 17 Nov 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Pulpotomy Versus Pulpectomy in Primary Molars With Irreversible Pulpitis or Necrotic Pulp: A Split-Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07230717
- Acronym / sponsor ID
- D-S-H-22-Jun
- Conditions
- Pulp Therapy, Pulpitis - Irreversible, Pulp Necrosis
- Keywords
- Pulpotomy, Pulpectomy, primary molars, irreversible pulpitis, necrotic pulp
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ajman UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 17 Nov 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.
Preserving primary teeth until their normal exfoliation time is crucial for maintaining the child's normal function, esthetics, arch integrity, and correct eruption of permanent successors. Given the growing interest in conservative procedures and the clinical need for simpler, more predictable pulp therapy outcomes in children, evaluating pulpotomy with Pulpotec as a potential alternative to pulpectomy is essential.
The aim of this study is to evaluate the clinical and radiographic success of pulpotomy using Pulpotec versus pulpectomy using Metapex, a calcium hydroxide with iodoform paste, to treat primary molars in children diagnosed with irreversible pulpitis or necrotic pulp in the Postgraduate Pediatric Dental Clinic at Ajman University, UAE. A total of 25 contralateral paired molar samples from children aged 4 to 8 will be included in this split-mouth randomized controlled study. Each child will serve as their own control, with one tooth randomized to the intervention group (Pulpotomy using Pulpotec) and the other to the control group (Pulpectomy using Metapex) to assess patients' clinical and radiographic outcomes over a 12-month follow-up period. Patients will have their dental anxiety psychometrically assessed using the RMS pictorial scale. In addition, a pulse oximeter will be used as a biological marker in the study to measure oxygen saturation and pulse rate.
Detailed description
With increasing emphasis on conservative and predictable pulp therapy in pediatric dentistry, this study aims to evaluate pulpotomy using Pulpotec as a potential alternative to pulpectomy using Metapex in the management of primary molars with irreversible pulpitis or necrotic pulp.
This split-mouth randomized controlled clinical trial will include 25 children aged 4-8 years attending the Postgraduate Pediatric Dental Clinic at Ajman University, UAE. Each participant will contribute two contralateral primary molars-one assigned to the intervention group (Pulpotomy with Pulpotec) and the other to the control group (Pulpectomy with Metapex, a calcium hydroxide and iodoform paste).
The outcome will assess and compare the clinical and radiographic success rates of pulpotomy and pulpectomy procedures performed in primary molars diagnosed with irreversible pulpitis or necrotic pulp. Clinical success will be defined by the absence of pain, swelling, sinus tract, mobility, or tenderness to percussion. Radiographic success will be defined by the absence of periapical or inter-radicular radiolucency, internal or external resorption, and evidence of continued root resorption consistent with normal exfoliation. In addition, dental anxiety will be assessed using the RMS Pictorial Anxiety Scale, and physiological parameters such as pulse rate (beats/min) and oxygen saturation (SpO₂, %) will be recorded using a pulse oximeter to explore potential correlations between anxiety and treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy | Experimental | Procedure: PulpotomyPulpotomy |
| Pulpectomy | Active comparator | Procedure: PulpectomyPulpectomy |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Patients in healthy medical conditions
- Bilateral/contralateral primary molars diagnosed with irreversible pulpitis or necrotic pulp
- Periapical or bifurcation radiolucency
- Chronic apical intraoral abscess
- Sinus tract or fistula formation
Key exclusion criteria (6 listed)
- Patients who are medically compromised (with systemic conditions)
- Acute extraoral abscess
- Grade II or III tooth mobility
- External root resorption in more than 1/3 of roots
- Physiological root resorption of more than 1/3 of the roots or near exfoliation
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 |
|---|---|---|
| PulpotomyPulpotomy with pulpotec Powder: (iodoform, polyoxymethylene, excipient) and a Liquid: (dexamethasone acetate, formaldehyde, phenol, guaiacol, excipient) mixed into a paste consistency as per manufacturer instruction. Pulpectomy with metapex Content: Calcium Hydroxide, Iodoform, Silicon oil | Procedure or surgery | Pulpotomy |
| PulpectomyCalcium Hydroxide, Iodoform, Silicon oil | Procedure or surgery | Pulpectomy |
Primary outcome
Clinical and radiographic success rates of pulpotomy versus pulpectomy in primary molars of children with irreversible pulpitis or necrotic pulp over a 12-month follow-up period
Time frame: 3 months, 6 months, 9 months, and 12 months follow up post-treatment.
The outcome will assess and compare the clinical and radiographic success rates of pulpotomy and pulpectomy procedures performed in primary molars diagnosed with irreversible pulpitis or necrotic pulp. Clinical success will be defined by the absence of pain, swelling, sinus tract, mobility, or tenderness to percussion. Radiographic success will be defined by the absence of periapical or inter-radicular radiolucency, internal or external resorption, and evidence of continued root resorption consistent with normal exfoliation.
3 secondary outcomes
Anxiety Level using RMS Pictorial Scale
Time frame: Baseline (in the waiting area before entering the operatory), Pre-operative (immediately before the start of the procedure), Operative (during the dental treatment), and Post-operative (immediately after completion of the procedure).
Pulse Rate in beats per minute (bpm) using Pulse Oximeter
Time frame: Baseline (in the waiting area before entering the operatory), Pre-operative (immediately before the start of the procedure), Operative (during the dental treatment), and Post-operative (immediately after completion of the procedure).
Oxygen Saturation (SpO₂) in percentage (%) using Pulse Oximeter
Time frame: Baseline (in the waiting area before entering the operatory), Pre-operative (immediately before the start of the procedure), Operative (during the dental treatment), and Post-operative (immediately after completion of the procedure).
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 17 Nov 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 Pulpectomy in people with Pulp Therapy and Pulpitis - Irreversible, run by Ajman University.
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 8 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 17 Nov 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?
Clinical and radiographic success rates of pulpotomy versus pulpectomy in primary molars of children with irreversible pulpitis or necrotic pulp over a 12-month follow-up period (time frame: 3 months, 6 months, 9 months, and 12 months follow up post-treatment.). 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 17 Nov 2025.