Clinical and Radiographic Evaluation of Chitosan Versus Formocresol After Vital Pulpotomy of Primary Molars

NCT06809478 | Not Yet Recruiting

• 1 other identifier: CS Pulpotomy
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether Chitosan liquid will show similar clinical and radiographical success rate compared to Formocresol when used in vital pulp therapy in primary molars. The main question it aims to answer is:

• Will Chitosan liquid, in comparison to Formocresol, show similar clinical outcomes in relation to presence/absence of post-operative pain, swelling, sinus and/or fistula formation when used in vital pulpotomy in primary molars?
• Will Chitosan liquid, in comparison to Formocresol, show similar radiographical outcomes in relation to presence/absence of furcal involvement, periapical lesion, pathological root resorption and/or widening of periodontal membrane space when used in vital pulpotomy in primary molars? Following conventional pulpotomy procedure, the primary investigator will evaluate the effect of placing a cotton pellet damp with Chitosan liquid directly on radicular vital pulp compared to that of placing a cotton pellet damp with Formocresol on radicular vital pulp. Primary teeth included in both arms of the study will be restored by zinc oxide and eugenol and covered by a stainless steel crown as final restoration. The clinical trail will be followed up for 1 year. Clinical outcomes will be evaluated every 3 months. Radiographic outcomes will be evaluated every 6 months.

Conditions

Pulpitis - Reversible; Pulpotomy

Keywords

pulpotomy; formocresol; chitosan; primary molars

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 3 months

  Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)

  Baseline and 3 months

• Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 6 months

  Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)

  Baseline and 6 months

• Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 9 months

  Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)

  Baseline and 9 months

• Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 12 months

  Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)

  Baseline and 12 months

Secondary Outcomes (16)

• Change from Baseline in regards to swelling at 3 months

  Baseline and 3 months

• Change from Baseline in regards to swelling at 6 months

  Baseline and 6 months

• Change from Baseline in regards to swelling at 9 months

  Baseline and 9 months

• Change from Baseline in regards to swelling at 12 months

  Baseline and 12 months

• Change from Baseline in regards to sinus or fistula at 3 months

  Baseline and 3 months

Study Arms (2)

Pulpotomy using Chitosan

EXPERIMENTAL

Chitosan is a natural cationic polysaccharide polymer obtained from chitin deacetylation. It is a linear biopolymer consisting of 2-amino-2-deoxy-β-D-glucose (60-100%) and 2-acetamino -2-deoxy-β-D-glucoside (0-50%) bound together by ß (1→4) bonds. It is biocompatible and has antibacterial, anti-inflammatory and hemostatic properties.

Procedure: Pulpotomy using Chitosan liquid

Pulpotomy using Formocresol

ACTIVE COMPARATOR

Buckley's formocresol is composed of 31% water base, 15% glycerin to prevent formaldehyde from polymerizing to paraformaldehyde, 19% formaldehyde as an alkylating agent, and 35% tricresol as a protein-coagulating phenolic substance. A 1:5 concentration of Buckley's formocresol is used in this trial.

Procedure: Pulpotomy using Formocresol

Interventions

Pulpotomy using Chitosan liquid PROCEDURE

1. After complete hemostasis, a cotton pellet damp with chitosan liquid will be applied and gently placed over the pulp stumps for 5 minutes and removed. Then, a thick mix of zinc oxide and eugenol will be placed and gently condensed into the pulp chamber by a moistened cotton pellet. 2. Tooth will be restored with stainless steel crown.

Also known as: Chitosan Pulpotomy

Pulpotomy using Chitosan

Pulpotomy using Formocresol PROCEDURE

1. After complete hemostasis, a cotton pellet damp with formocresol will be applied and gently placed over the pulp stumps for 5 minutes and removed. Then, a thick mix of zinc oxide and eugenol will be placed and gently condensed into the pulp chamber by a moistened cotton pellet. 2. Tooth will be restored with stainless steel crown.

Also known as: Formocresol Pulpotomy

Pulpotomy using Formocresol

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy cooperative children with at least one deep carious mandibular primary molar indicated for vital pulpotomy.
• In age range from 4 to 8 years old.
• Both sexes will be included.
• Patients with provoked pain.
• Restorable teeth.

You may not qualify if:

• Excessive haemorrhage that cannot be stopped by a damp cotton pellet after several minutes.
• With congenital anomalies in teeth e.g., taurodontism, concrescence or fusion.
• Patients who show allergic reaction to any material will be used in this trial.
• Will not be able to stick to follow up protocol in the trial and refuse to give communication data.
• Patient's guardians refuse to sign up an informed consent before participating in this trial.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Central Study Contacts

Reem I Helmi

CONTACT

(+20) 1151806686; reem.helmi@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 5, 2025
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)