Actively Recruiting

Phase Not Applicable
Age: 7Years - 15Years
All Genders
Healthy Volunteers
ID07323433

Efficacy of a Chitosan Dressing in Pulpotomy of Immature Permanent Teeth Randomized Clinical Trial

Led by Minia University · Updated on 2026-01-07

26

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of chitosan dressing in pulpotomy procedures for immature permanent teeth, which are young teeth with incomplete root formation. These teeth are vulnerable to decay and injury that can expose and damage the pulp, stopping root development and leaving the tooth fragile. Preserving pulp vitality is crucial to allow continued root growth. Pulpotomy, a common method to keep pulp healthy by removing infected tissue and covering the area with a biocompatible material, is recommended for managing pulp exposure in these teeth. This study compares two treatments for pulpotomy in immature permanent teeth affected by caries or trauma: one group receives a chitosan dressing applied to the pulp stump to control bleeding, while the other group receives cotton dampened with normal saline for hemostasis. Chitosan is a natural, non-toxic substance with antimicrobial and healing properties, and its effectiveness and safety in this dental procedure are being assessed. Participants will be randomly assigned to one of these two groups. Participants aged 7 to 15 with immature maxillary anterior teeth affected by caries or trauma will be involved. The study includes a follow-up period of up to 12 months, during which outcomes such as post-operative pain will be monitored. Researchers will evaluate the success of treatment through clinical assessments and patient reports over this time. The trial aims to provide evidence on the use of chitosan dressings to support healing and root development in immature permanent teeth.

CONDITIONS

Brief Title

Efficacy of a Chitosan Dressing in Pulpotomy of Immature Permanent Teeth

Who Can Participate

Age: 7Years - 15Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with immature maxillary anterior teeth
  • Patients with caries or traumatic exposed teeth
  • Patients free from systemic disease affecting healing (class I ASA)
  • Patients who agree to consent and commit to follow-up period
Not Eligible

You will not qualify if you...

  • Patients with mature roots
  • Patients with systemic disease affecting healing
  • Patients with signs of periapical inflammation
  • Patients unable or unwilling to participate in 1-year follow-up
  • Teeth with periodontal involvement
  • Teeth with vertical root fractures
  • Non-restorable teeth
  • Cases with previously initiated endodontic treatment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment

Treatment

Duration - Single treatment visit

Participants undergo pulpotomy where a chitosan dressing or a cotton damped with normal saline is applied to the pulp stump for hemostasis in immature permanent teeth.

1 treatment visit (in-person)

Follow-up

Duration - 6 to 12 months

Participants are monitored for post-operative pain and treatment success during a follow-up period lasting up to 12 months.

Multiple follow-up visits over 6 to 12 months

Trial Site Locations

Total: 1 location

1

Minia University Hospital

Minya, Egypt

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Research Team

S

Salsabil Mohammed Naguib, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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