Efficacy of a Chitosan Dressing in Pulpotomy of Immature Permanent Teeth

NCT07323433 | Recruiting DMC

• 1 other identifier: Chitosan Dressing
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Immature permanent teeth, also known as young permanent teeth, are used to describe teeth with incomplete root formation. Immature permanent teeth are prone to caries and trauma which can cause exposure and degeneration of pulp. Pulp degeneration stops root formation, leaving teeth with open apex. It is vital to preserve the pulp vitality otherwise the incompletion of root might result in the fragility of teeth. Pulpotomy is one of the most widely used methods in preserving vital pulp in teeth, which is of great significance in achieving continue root formation in immature permanent teeth suffering from dental caries or trauma. Pulpotomy is recommended by the American Association of Pediatric Dentistry for the management of pulp exposure in immature permanent teeth to achieve apexogenesis (continued root formation and closure of apex). In this procedure, coronal pulp tissue is removed in order to eliminate the infected or contaminated pulp and to reach the healthy vital pulp followed by coverage with biocompatible material.

Conditions

Caries,Dental

Outcome Measures

Primary Outcomes (1)

• Post Operative Pain

  Assessment of the post operative pain via Numerical Pain Rating Scale (NRS) where the level of pain will be recorded as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".

  6 Months till 12 months

Study Arms (2)

Group Hemcon Dressing

ACTIVE COMPARATOR

About 13 Participants presented with traumatic or caries exposed upper anterior teeth with immature root and they will be subjected to Application of Hemcon Dressing as A dressing material for hemostasis on pulp stump during pulpotomy of the immature teeth.

Procedure: Chitosan Dressing

Group of Cotton damped with normal saline

ACTIVE COMPARATOR

About 13 Participants presented with traumatic or caries exposed upper anterior teeth with immature root and they will be subjected to Application of cotton damped with normal saline for hemostasis on pulp stump during pulpotomy of the immature teeth.

Procedure: Chitosan Dressing

Interventions

Chitosan Dressing PROCEDURE

To evaluate the effect of chitosan dressing in pulpotomy of immature permanent teeth

Also known as: Hemcon Dressing, pulpotomy of immature permanent teeth, Cotton damped with normal saline

Group Hemcon Dressing; Group of Cotton damped with normal saline

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients with immature maxillary anterior teeth.
• Patients with caries or traumatic exposed teeth .
• Patients should be free from any systemic disease that may affect normal healing and predictable outcome class I ASA .
• Patients who will agree to the consent and will commit to follow-up period.

You may not qualify if:

• Patients with mature roots.
• Patients with any systemic disease that may affect normal healing.
• Patients with signs of periapical inflammation.
• Patients who could/would not participate in a 1-year follow-up.
• Teeth with periodontal involvement.
• Teeth with vertical root fractures.
• Non- restorable teeth.
• cases with previously initiated endodontic treatment.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University Hospital

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Lamiaa Ahmed Ebrahem, Professor

  Department of endodontics Dean of Faculty of Dentistry Fayoum University

  STUDY CHAIR

Central Study Contacts

Salsabil Mohammed Naguib, MSc

CONTACT

+201026598006; salsabilnaguib@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist at Health Insurance Endodontics , Minia city

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: January 7, 2026
• Study Start: August 25, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-08

Locations

EG (1)