Comparative Evaluation of Three Different Pulpotomy Agents in Primary Molars

Summary

Comparative Evaluation of Mineral Trioxide Aggregate (MTA), Ferric Sulfate, and Chitosan Hydrogel for Primary Molar Pulpotomy: An 18-Month Randomized Controlled Trial

Why is this study being done? When a child's tooth has a deep cavity, the decay can reach the soft inner part of the tooth called the pulp. A common treatment is called a pulpotomy - the dentist removes the infected part of the pulp and places a special material to protect the healthy root and save the tooth. Several materials are used for this treatment, but dentists do not yet agree on which one works best. This study compares three materials: (1) Mineral Trioxide Aggregate (MTA) - a well-known dental cement; (2) Ferric Sulfate (FS) - a liquid that stops bleeding; and (3) Chitosan Hydrogel - a new, natural gel made from shellfish shells. The goal is to find out which material keeps the treated tooth healthy for the longest time.

Who can take part? Healthy children aged 5 to 8 years who have at least one baby back tooth (primary molar) that needs a pulpotomy treatment may be eligible. Children with tooth pain, swelling, infection, or teeth that are too damaged will not be included. A parent or guardian must give written permission for their child to join the study.

What will happen during the study? 165 children will join the study and be randomly placed (like a coin toss) into one of three groups - each group receives a different pulpotomy material. The treatment is a routine pulpotomy done under local anesthesia (numbing injection) by an experienced pediatric dentist. After the pulpotomy material is placed, the tooth is sealed with a protective metal crown. Children will have check-up visits at 3, 6, 12, and 18 months. At each visit, the dentist checks the tooth by examination and by taking a small X-ray.

What are the possible risks? The risks are similar to those of any routine pulpotomy. Some children may feel mild soreness for 1 to 2 days after treatment. All three materials used in this study have been used in previous dental research. Children with shellfish allergies will be screened before enrollment.

What are the possible benefits? Participating children receive free professional dental treatment and regular check-ups at no cost for 18 months. The treatment aims to save the child's baby tooth, helping with chewing, speech, and guiding permanent teeth into the right position. The results of this study will help dentists choose the best treatment for children's teeth.

Is participation voluntary? Yes. Joining this study is completely voluntary. Parents and children may choose not to participate or may withdraw at any time without any effect on their future dental care. If a family does not join or decides to leave, their child will still receive standard dental treatment.

How is my child's information kept private? All information collected during this study is kept strictly confidential. Children's names are replaced with codes. Only the research team can access identifiable information. Results will be published in a way that does not identify any individual child.

Conditions

• Pulpotomies Primary Teeth
• Dental Pulp Disease
• Primary Teeth

Interventions

DEVICE

2% Chitosan Hydrogel

chitosan powder (85% deacetylated, 300-350 kDa) was dissolved in 1% acetic acid, neutralized to pH 7.0, and sterilized by gamma irradiation (25-30 kGy), yielding a hydrogel with viscosity of approximately 850 cP

DRUG

MTA

White ProRoot® MTA (Dentsply, Maillefer, Tulsa Dental Specialties, Switzerland)

DRUG

Ferric Sulfate

5.5% Ferric Sulfate Solution (Astringedent®)

Sponsors & Collaborators

• Al-Mustansiriyah University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-01

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• Iraq

Study Locations