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

NCT07557290 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: MG-MTA-Pulpotomy-2026
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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". 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:

1. 1.Mustard Gel Group : tooth will be treated with mustard gel after nerve removal
2. 2.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

Keywords

Herbal Pulptomy agents for primary molars

Outcome Measures

Primary Outcomes (1)

• 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.

  At 1 week, 1 month, 3 months post treatment.

Study Arms (2)

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.

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.

Drug: Intervention 2 : Mineral Trioxide Aggregate (MTA)

Interventions

Intervention 1: Mustard Gel DRUG

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.

Arm A : Mustard Gel Pulpotomy

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.

Arm B: Mineral Trioxide Aggregate Pulpotomy

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Nida Farooq: lead

MeSH Terms

Conditions

Dental Pulp Exposure

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: double blinded where participants and data analyst will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post Graduate Resident, Department of Operative Dentistry

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04