Carious Primary Molars
Conditions
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
Interventions
OTHERGroup 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.
OTHERGroup 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
statistician
Eligibility
Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | [Time Frame: follow-up: T(Time):12months interval T0:0 T1:3month T2:6month T3:9month T4:12month] | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Success | [Time Frame: follow-up: T(Time):12months interval T0:0 T2:6month T4:12month] | 1. Absence or reduction in the size of periapical radiolucency Method of measurement: Visual interpretation for intra-oral periapical radiograph Outcome measuring unit: Binary(Yes/No) 2. Absence or reduction in the size of furcation radiolucency Method of measurement: Visual interpretation for Intra-oral periapical radiograph Outcome measuring unit: Binary(Yes/No) |
Countries
Egypt
Contacts
Primary ContactTasneem Ali Osman Ali, Master degree
Outcome results
None listed