Comparison of ZOE vs ZON in Primary Mandibular Molars Pulpectomy of 5-7-Year-Olds

NCT07090252 | Not Yet Recruiting

• 1 other identifier: CRP-ZOE Vs ZON
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluation of Zinc oxide-eugenol compared to Zinc oxide with Neem as obturating materials in primary mandibular molars pulpectomy for 5-7 Year-Old Children.The main question(s)it aim to answer : Could the clinical and radiographic success of a mixture of zinc oxide with Neem oil be comparable with Zinc oxide-eugenol paste in pulpectomy of primary mandibular molars?

Conditions

Carious Primary Molars

Outcome Measures

Primary Outcomes (1)

• Clinical Success

  1. Absence of pain method of measurement: verbal question to patient/parent Outcome measuring unit: Binary(Yes/No) 2. Absence of tenderness to percussion method of measurement: percussion test by the back of the dental mirror Outcome measuring unit: Binary(Yes/No) 3. Absence of swelling and sinus tract method of measurement: Visual and Clinical examination Outcome measuring unit: Binary(Yes/No) 4. Absence of mobility: method of measurement: Mobility test by using two single-ended instruments(dental mirror and probe) Outcome measuring unit: Binary(Yes/No)

  [Time Frame: follow-up: T(Time):12months interval T0:0 T1:3month T2:6month T3:9month T4:12month]

Secondary Outcomes (1)

• Radiographic Success

  [Time Frame: follow-up: T(Time):12months interval T0:0 T2:6month T4:12month]

Study Arms (2)

Group I zinc oxide with Neem

EXPERIMENTAL

Neem and zinc oxide powder have been improved as a theraputic agents with high antibacterial, antioxidant, and enzyme-inhibiting properties against microorganisms resistant to antibiotics.Neem contains many chemically diverse and structurally complex phytochemicals, such as limonoids, flavonoids, phenols, catechins, gallic acid,polyphenols, and nimbins which contribute to their different pharmacological activities.

Other: Group I zinc oxide Neem

Group II zinc oxide -eugenol

EXPERIMENTAL

zinc oxide eugenol is a mixture of zinc oxide (powder) and eugenol (liquid). Zinc oxide and eugenol (ZOE) paste is a standard in dentistry among the pastes used in the pulp therapy of primary teeth.

Other: Group II zinc oxide eugenol

Interventions

Group I zinc oxide Neem OTHER

preperation: 1\\ A standardized access cavity procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove coronal pulpal tissues then will remove radicular pulp by barbed broach then will be used K files for chemo mechanical preparation (size 15,20,25) with saline (2%) irrigation to remove necrotic pulp tissues then all the canals will be dried using paper points. 2\\ After complete excavation of all pulp tissue, saline irrigation is done then the canals will be obturated zinc-oxide with Neem ( Zinc oxide powder(Prime Dental Pvt. Ltd.Thane, Maharashtra, India) and 100% Neem oil with mixing ratio of 1:3 will be mixed on a glass slab with a stainless- steel spatula) and then the rest of the pulp chamber will be filled with Zinconol. (reinforced zinc oxide eugenol)3\\ Tooth will be restored with stainless steel crown.

Group I zinc oxide with Neem

Group II zinc oxide eugenol OTHER

preperation: 1\\ A standardized access cavity procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove coronal pulpal tissues then will remove radicular pulp by barbed broach then will be used K files for chemo mechanical preparation (size 15,20,25) with saline (2%) irrigation to remove necrotic pulp tissues then all the canals will be dried using paper points 2\\ After complete removed of coronal and radicular pulp zinc oxide eugenol will be manipulated in the ratio of 3:1 (powder: liquid) to obtain semisolid mix.This mix will be placed in the canals. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by the application of Zinconol.3\\ Tooth will be restored with stainless steel crown.

Group II zinc oxide -eugenol

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 5-7 years with infected primary molars.
• Deep carious lesion.
• History of spontaneous pain
• Parent written informed consent.

You may not qualify if:

• Medically compromised children
• Children with a history of allergic reaction to the components of the tested material
• Children who had non restorable teeth
• Teeth with less than two third of root length
• Extensive internal or external root resorption
• Unable to attend follow-up visits

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Faculty of Dentistry

Cairo, El-manial, 3387722, Egypt

Location

Study Officials

• Adel Elbardissy, Prof Doctor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Tasneem Ali Osman Ali, Master degree

CONTACT

+201151360396; tasneem.ali@dentistry.cu.edu.eg

Study Design

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

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)