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

ConditionCarious Primary Molars

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age5-7

SponsorCairo University

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 5-7 years with infected primary molars.

Deep carious lesion.

History of spontaneous pain

Parent written informed consent.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Group I zinc oxide Neem
Other intervention
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
Other intervention
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.

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: Group I zinc oxide with NeemExperimental treatment 1 intervention

Group B: Group II zinc oxide -eugenolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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

Secondary outcomes

Radiographic Success

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)

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

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