Dental Pulp ExposurePhase 1MG-MTA-RCT2026NCT07557290
Comparative Evaluation of Clinical and Radiographic Outcomes of Mustard Gel (Brassica Nigra) and Mineral Trioxide Aggregate (MTA) as Pulpotomy Agents in Deciduous Molars- A Randomized Controlled Trial
A Phase 1 study testing Intervention 1: Mustard Gel and Intervention 2 : Mineral Trioxide Aggregate (MTA) in people with Dental Pulp Exposure, run by Dr Nida Farooq.
Trial summary
The aim of this clinical trial is to compare two materials to treat baby molars with deep cavities. When the cavity is very deep and reaches the nerve of a baby tooth, dentist perform a treatment called "Pulpotomy". Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Dental Pulp Exposure
- What is being tested?
- Intervention 1: Mustard Gel and Intervention 2 : Mineral Trioxide Aggregate (MTA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to Aug 2026
- Phase
- Phase 1
- 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- healthy co-operative children 6-8 years old
- primary molars with deep cavities and iatrogenic pulp exposure
- clinically with no sign of spontaneous pain, sinus tract, tenderness to percussion, pathological mobility
- radiographically with absence of periapical radiolucency, internal/external root resorption, furcal radiolucency
- hemorrhage at the site of amputation controlled with 5 minutes
- tooth should be vital with healthy peridontium
- tooth should be restoreable
Who cannot join
- teeth without permanent successor
- teeth with history of irreversible pulpitis
- post amputation unsuccessful hemorrhage control even after 5 minutes
- radiographic evidence of internal/external root resorption, furcal/periapical pathology
- patients with drug allergies or systemic diseases
- clinical signs of spontaneous pain, sinus tract, tenderness to percussion, pathological mobility
About this study
The aim of this clinical trial is to compare two materials to treat baby molars with deep cavities. When the cavity is very deep and reaches the nerve of a baby tooth, dentist perform a treatment called "Pulpotomy". This means removing the damaged part of the nerve and placing medicament on healthy part to help tooth heal and stay pain-free until it falls out naturally. The standard medicine used today is Mineral Trioxide Aggregate (MTA) for treating baby molars that have deep cavities. It works well but is expensive and can darken the tooth. The study is testing a new medicine called Mustard Gel , made from black mustard seeds and may help heal the tooth. Mustard has natural healing and germ-fighting properties.This trial will help to compare Mustard Gel with MTA to see if the agent works to treat pulpitis.
Children aged 6-8 years who need a pulpotomy procedure on a baby molar will be selected. During this procedure, infected part of the pulp tissue will be removed and medicament will be placed over the remaining healthy pulp.
Read more
Selected participants will be put into one of the two groups by chance:
- Mustard Gel Group : tooth will be treated with mustard gel after nerve removal
- MTA Group : tooth will be treated with MTA, the current standard material. All the teeth will be sealed with a permanent filling material.Participants will be treated with both drugs and monitored after about 1 week, 1 month and 3 months to see if the tooth is pain-free and looks healthy on X-ray. The study will help check if Mustard gel is safe and if it causes any side effects.
- Conditions
- Dental Pulp Exposure
- Being tested
- Intervention 1: Mustard Gel, Intervention 2 : Mineral Trioxide Aggregate (MTA)
- Keywords
- Herbal Pulptomy agents for primary molars
- Medical subject headings
- Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1: Mustard GelDrug
Gel obtained from Brassica nigra (Black Mustard) seeds will be used as pulpotomy medicament in primary molars placed over pulp stumps after coronal pulp amputation. Approximately 1mm of mustard gel will be applied and tooth will be sealed with permanent filling material.
Intervention 2 : Mineral Trioxide Aggregate (MTA)Drug
MTA will be mixed according to manufacturer's instructions and placed over the pulp stumps to a thickness of 1-2 mm using an amalgam carrier. It will be compressed gently with damp cotton pellet, the restored with glass-ionomer cement.
| Study group | Role | What they receive |
|---|---|---|
| Arm A : Mustard Gel Pulpotomy | Experimental | Primary molars will undergo pulpotomy followed by application of Mustard Gel in as pulpotomy medicament. After the removal of coronal pulp tissue and hemostasis the mustard gel will be applied directly over the radicular pulp stumps under aseptic conditions followed by the placement of suitable base and permanent filling material to seal tooth. Clinical and radiographic follow up will be done at 1 week, 1 month, and 3 months. Receives: Drug: Intervention 1: Mustard Gel |
| Arm B: Mineral Trioxide Aggregate Pulpotomy | Active comparator | MTA will be used as pulpotomy agent in decidoud molars following standard clinical procedure after coronal pulp amputation. The treated tooth will be restored with appropriate base and final restoration. Clinical and radiographic follow up will be done at 1 week, 1 month and 3 months. Receives: Drug: Intervention 2 : Mineral Trioxide Aggregate (MTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and Radiographic success rate of Pulpotomy
The proportion of the teeth treated with pulpotomy that show clinical and radiographic success. Clinical success rate is defined as absence of pain, swelling, abscess or pathological mobility.
Radiographic success is defined as absence of internal/external root resorption, furcal/periapical radiolucency or widened PDL space.
assessment will be done using clinical examination and periapical radiographs.
Measured: At 1 week, 1 month, 3 months post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp ExposureStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Nida Farooq
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Nida Farooq, Postgraduate Medical Institute, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557290
- Sponsor's protocol ID
- MG-MTA-Pulpotomy-2026
- Acronym
- MG-MTA-RCT2026
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 29 Apr 2026
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Clinical and Radiographic Outcomes of Mustard Gel (Brassica Nigra) and Mineral Trioxide Aggregate (MTA) as Pulpotomy Agents in Deciduous Molars- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07557290
- Acronym / sponsor ID
- MG-MTA-RCT2026 / MG-MTA-Pulpotomy-2026
- Conditions
- Dental Pulp Exposure
- Keywords
- Herbal Pulptomy agents for primary molars
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Dr Nida FarooqUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 29 Apr 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 aim of this clinical trial is to compare two materials to treat baby molars with deep cavities. When the cavity is very deep and reaches the nerve of a baby tooth, dentist perform a treatment called "Pulpotomy". This means removing the damaged part of the nerve and placing medicament on healthy part to help tooth heal and stay pain-free until it falls out naturally. The standard medicine used today is Mineral Trioxide Aggregate (MTA) for treating baby molars that have deep cavities. It works well but is expensive and can darken the tooth. The study is testing a new medicine called Mustard Gel , made from black mustard seeds and may help heal the tooth. Mustard has natural healing and germ-fighting properties.This trial will help to compare Mustard Gel with MTA to see if the agent works to treat pulpitis.
Children aged 6-8 years who need a pulpotomy procedure on a baby molar will be selected. During this procedure, infected part of the pulp tissue will be removed and medicament will be placed over the remaining healthy pulp.
Selected participants will be put into one of the two groups by chance:
- Mustard Gel Group : tooth will be treated with mustard gel after nerve removal
- MTA Group : tooth will be treated with MTA, the current standard material. All the teeth will be sealed with a permanent filling material.Participants will be treated with both drugs and monitored after about 1 week, 1 month and 3 months to see if the tooth is pain-free and looks healthy on X-ray. The study will help check if Mustard gel is safe and if it causes any side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A : Mustard Gel Pulpotomy | Experimental | Drug: Intervention 1: Mustard GelPrimary molars will undergo pulpotomy followed by application of Mustard Gel in as pulpotomy medicament. After the removal of coronal pulp tissue and hemostasis the mustard gel will be applied directly over the radicular pulp stumps under aseptic conditions followed by the placement of suitable base and permanent filling material to seal tooth. Clinical and radiographic follow up will be done at 1 week, 1 month, and 3 months. |
| Arm B: Mineral Trioxide Aggregate Pulpotomy | Active comparator | Drug: Intervention 2 : Mineral Trioxide Aggregate (MTA)MTA will be used as pulpotomy agent in decidoud molars following standard clinical procedure after coronal pulp amputation. The treated tooth will be restored with appropriate base and final restoration. Clinical and radiographic follow up will be done at 1 week, 1 month and 3 months. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- healthy co-operative children 6-8 years old
- primary molars with deep cavities and iatrogenic pulp exposure
- clinically with no sign of spontaneous pain, sinus tract, tenderness to percussion, pathological mobility
- radiographically with absence of periapical radiolucency, internal/external root resorption, furcal radiolucency
- hemorrhage at the site of amputation controlled with 5 minutes
Key exclusion criteria (6 listed)
- teeth without permanent successor
- teeth with history of irreversible pulpitis
- post amputation unsuccessful hemorrhage control even after 5 minutes
- radiographic evidence of internal/external root resorption, furcal/periapical pathology
- patients with drug allergies or systemic diseases
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 |
|---|---|---|
| Intervention 1: Mustard GelGel obtained from Brassica nigra (Black Mustard) seeds will be used as pulpotomy medicament in primary molars placed over pulp stumps after coronal pulp amputation. Approximately 1mm of mustard gel will be applied and tooth will be sealed with permanent filling material. | Drug | Arm A : Mustard Gel Pulpotomy |
| Intervention 2 : Mineral Trioxide Aggregate (MTA)MTA will be mixed according to manufacturer's instructions and placed over the pulp stumps to a thickness of 1-2 mm using an amalgam carrier. It will be compressed gently with damp cotton pellet, the restored with glass-ionomer cement. | Drug | Arm B: Mineral Trioxide Aggregate Pulpotomy |
Primary outcome
Clinical and Radiographic success rate of Pulpotomy
Time frame: At 1 week, 1 month, 3 months post treatment.
The proportion of the teeth treated with pulpotomy that show clinical and radiographic success. Clinical success rate is defined as absence of pain, swelling, abscess or pathological mobility. Radiographic success is defined as absence of internal/external root resorption, furcal/periapical radiolucency or widened PDL space. assessment will be done using clinical examination and periapical radiographs.
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 29 Apr 2026.
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Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
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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 Phase 1 study testing Intervention 1: Mustard Gel and Intervention 2 : Mineral Trioxide Aggregate (MTA) in people with Dental Pulp Exposure, run by Dr Nida Farooq.
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 7 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 29 Apr 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 rate of Pulpotomy (time frame: At 1 week, 1 month, 3 months 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 29 Apr 2026.