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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Carious Primary Molars

Treatments: Other: Group I zinc oxide Neem; Other: Group II zinc oxide eugenol

Study type: Interventional

Funder types: Other

Identifiers

NCT07090252

CRP-ZOE Vs ZON

Details and patient eligibility

About

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?

Full 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

Enrollment: 24 estimated patients

Sex: All

Ages: 5 to 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Group I zinc oxide with Neem

Experimental group

Description:

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.

Treatment:

Other: Group I zinc oxide Neem

Group II zinc oxide -eugenol

Experimental group

Description:

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.

Treatment:

Other: Group II zinc oxide eugenol