Comparative Evaluation of Three Different Pulpotomy Agents in Primary Molars

NCT07541976 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: MUPEDO6REC206
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MTA; Ferric Sulfate; Chitosan; primary molars; vital pulp therapy; pulpotomy

Outcome Measures

Primary Outcomes (1)

• Overall Treatment Success

  Overall success is defined as the simultaneous presence of clinical success AND radiographic success at the 18-month follow-up visit. Clinical success requires ALL of the following: No spontaneous pain reported by the child or parent No tenderness to percussion No soft tissue swelling or sinus tract No pathological tooth mobility (beyond normal physiologic mobility for a primary tooth) Radiographic success requires ALL of the following on a periapical radiograph: No internal pathologic root resorption No external pathologic root resorption No furcation radiolucency No periapical radiolucency No widening of the periodontal ligament space beyond normal limits A tooth is classified as a failure if it lacks either clinical success or radiographic success (or both) at the 18-month time point. Teeth that fail at any earlier visit are recorded as failures from that time onward and counted as failures at 18 months (intention-to-treat principle)

  18 months post-pulpotomy

Study Arms (3)

2% Chitosan Hydrogel Arm

EXPERIMENTAL

Participants in this arm received a single pulpotomy treatment using a 2% (w/v) chitosan hydrogel as the medicament. The 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. After standardized coronal pulp amputation and hemostasis (saline-moistened cotton pellet for up to 5 minutes), the sterile hydrogel was applied 2-3 mm thick directly onto the pulp stumps using a syringe. No additional hemostatic or capping agent was placed over the hydrogel. The tooth was then restored with a reinforced glass ionomer base (Fuji IX GP) and a preformed stainless-steel crown. No re-application or repeat intervention was performed. The intervention was administered once at baseline (day of pulpotomy), with no further chitosan applications during follow-up.

Device: 2% Chitosan Hydrogel

15.5% Ferric Sulfate Solution (Astringedent®) Arm

SHAM COMPARATOR

Participants in this arm received a single pulpotomy treatment using 15.5% ferric sulfate solution (Astringedent®, Ultradent) as the hemostatic and pulpotomy medicament. After standardized coronal pulp amputation and initial hemostasis (saline-moistened cotton pellet for up to 5 minutes), the ferric sulfate solution was applied directly onto the pulp stumps using a microbrush for 15 seconds, then thoroughly rinsed with sterile saline. No additional bioactive capping material was placed directly over the pulp. Over the treated pulp stumps, a layer of reinforced zinc-oxide eugenol (IRM, Dentsply) was placed as a base. The tooth was then restored with a reinforced glass ionomer base (Fuji IX GP) and a preformed stainless-steel crown. The intervention was administered once at baseline (day of pulpotomy), with no re-application of ferric sulfate during follow-up.

Drug: Ferric Sulfate

White ProRoot® Mineral Trioxide Aggregate (MTA)

ACTIVE COMPARATOR

Participants in this arm received a single pulpotomy treatment using White ProRoot® MTA (Dentsply, Maillefer, Tulsa Dental Specialties, Switzerland) as the pulpotomy medicament. After standardized coronal pulp amputation and hemostasis (saline-moistened cotton pellet for up to 5 minutes), the MTA powder was mixed with sterile water according to the manufacturer's instructions to form a putty-like consistency. The mixed MTA was then placed as a 2-3 mm thick layer directly onto the pulp stumps and gently condensed. No rinsing was performed. The material was allowed to set in the moist environment of the pulp chamber. Over the set MTA, a reinforced glass ionomer base (Fuji IX GP) was placed, followed by a preformed stainless-steel crown. The intervention was administered once at baseline (day of pulpotomy), with no re-application of MTA during follow-up.

Drug: MTA

Interventions

2% Chitosan Hydrogel DEVICE

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

2% Chitosan Hydrogel Arm

MTA DRUG

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

White ProRoot® Mineral Trioxide Aggregate (MTA)

Ferric Sulfate DRUG

5.5% Ferric Sulfate Solution (Astringedent®)

15.5% Ferric Sulfate Solution (Astringedent®) Arm

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 5-8 years
• At least one carious primary molar requiring pulpotomy treatment
• Vital pulp confirmed at the exposure site after caries removal
• Tooth restorable with a stainless-steel crown
• Parent or legal guardian willing and able to provide written informed consent

You may not qualify if:

• Non-vital pulp (no bleeding after pulp amputation)
• History of spontaneous pain (suggesting irreversible pulpitis)
• Presence of soft tissue swelling or sinus tract related to the target tooth
• Pathological tooth mobility
• Radiographic evidence of:
• Internal or external pathological root resorption
• Furcation or periapical radiolucency
• More than one-third physiological root resorption
• Any condition preventing successful stainless-steel crown placement (e.g. Insufficient coronal tooth structure)

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

Al-Mustansiriyah University

Baghdad, Rusafa, 10001, Iraq

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Pemetrexed; ferric sulfate

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Lecturer in Pediatric Dentistry, College of Dentistry, Mustansiriyah University, Iraq

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 21, 2026
• Study Start: March 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: April 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)