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

NCT ID: NCT07090252

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-11-01

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?

Detailed Description

Dental caries is a global public health issue that mostly affects children in their early childhood, negatively impacting both their oral and overall health .The primary teeth with pulpal and periapical problems, should be kept until their natural exfoliation because their early loss could result in undesired abnormalities in the dentition later on . The complex root canal morphology, intrinsic physiologic root resorption, close proximity to the permanent successors, difficulty obtaining good radiographic views of the tooth apices, complex diagnosis due to the patient's immaturity, requirement for behavioral guidance of pediatric patients, technique selection, and root filling material selection make pulpectomy in primary teeth still controversial .When the pulp becomes irreversibly infected or necrotic, root canal therapy is recommended for children. The most common root canal filling material for primary teeth is zinc oxide eugenol (ZOE). However, it has some drawbacks, including slow resorption, periapical tissue irritation, and bone and cementum necrosis, which can result in anterior cross bite, palatal eruption, or ectopic eruption of a succedaneous tooth. As a result, ongoing research is required to find the ideal obturation material.To ensure the success of the endodontic treatment, various materials with good antimicrobial properties are used as root canal filling materials in primary teeth Phytodentistry has become a growing field in dentistry. It refers to the use of medicinal plants and their products to treat disease, either directly or indirectly. ZOE has been attempted with a variety of chemicals to improve its characteristics and success rate, however neither the success rate nor the material's resorbability were improved when compared to ZOE alone.Eugenol irritates the periapical area and solidifies into hard mass when combined with ZnO powder. Neem belongs to the family Meliaceae, also known as Azadirachta indica, is a plant that originated in India and now thrives in tropical and subtropical regions worldwide. It is highly valued for its therapeutic benefits. Neem contains a variety of biologically active compounds, including alkaloids, flavonoids, triterpenoids, phenolic compounds, carotenoids, steroids, and ketones. It has strong antimicrobial properties that can help manage and prevent various infections.This can aid in pharmacovigilance by monitoring and managing antibiotic and antimicrobial side effects. It has many medical uses such as immunoregulatory, antifungal, antihyperglycemic, antiulcer, antimalarial, anti inflammatory, antibacterial, antiviral, and antioxidant

Conditions

Carious Primary Molars

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group I zinc oxide with Neem

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.

Group Type: EXPERIMENTAL

Group I zinc oxide Neem

Intervention Type: 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 II zinc oxide -eugenol

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.

Group Type: EXPERIMENTAL

Group II zinc oxide eugenol

Intervention Type: 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.

Interventions

Group I zinc oxide Neem

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.

Intervention Type: OTHER

Group II zinc oxide eugenol

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Children aged 5-7 years with infected primary molars.

2. Deep carious lesion.

3. History of spontaneous pain

4. Parent written informed consent.

Exclusion Criteria

1. Medically compromised children

2. Children with a history of allergic reaction to the components of the tested material

3. Children who had non restorable teeth

4. Teeth with less than two third of root length

5. Extensive internal or external root resorption

6. Unable to attend follow-up visits

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Tasneem Ali Osman Ali

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adel Elbardissy, Prof Doctor

Role: STUDY_DIRECTOR

Cairo University

Locations

Cairo University Faculty of Dentistry

Cairo, El-manial, Egypt

Countries

Egypt

Central Contacts

Tasneem Ali Osman Ali, Master degree

Role: CONTACT

tasneem.ali@dentistry.cu.edu.eg

+201151360396

Facility Contacts

Cairo University Faculty of Dentistry

Role: primary

rec@dentistry.cu.edu.eg

0020223642705

Other Identifiers

CRP-ZOE Vs ZON

Identifier Type: -

Identifier Source: org_study_id