Clinical & Radiographic Evaluation of Zinc Oxide-Ozonated Oil as a New Primary Root Canal Filling

Tanta University

Status: Completed

Conditions: Obturation; Pulp Disease, Dental; Root Canal Infection

Treatments: Radiation: radiographic evaluation; Procedure: pulpectomy procedure and the clinical evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT05633537

#R- PED-1-21-2

Details and patient eligibility

About

Preserving primary teeth is essential for many aspects such as the child's growth and development, esthetic, functional, psychological, and dental arch integrity aspects. a randomized blinded controlled clinical trial aimed to evaluate the clinical and radiographic success of Zinc Oxide-Ozonated Olive Oil as root canal filling materials for primary molars compared to Zinc Oxide-Olive Oil & Zinc Oxide-eugenol. 90 primary molars of 30 children aged between 4-8 years with pulpally involved primary molars, are equally divided into 3 groups which treated with Zinc Oxide-Ozonated Olive Oil , zinc oxide -olive oil and zinc oxide eugenol as obturation materials following pulpectomy procedure. The subjects were followed up clinically and radiographically at 3, 6 and 12 months.

Full description

Pulpectomy for primary teeth involves root canal preparation followed by obturation with a resorbable material. Zinc oxide eugenol (ZOE) is the most widely used obturating material. The main ZOE disadvantages are the difference in rate of resorption compared to the root, and limited antimicrobial activity. ZOE is formed when crude eugenol is mixed with zinc oxide. the set material easily hydrolyzes, resulting in free eugenol release which can be harmful to human soft tissues; this motivated the search for a new eugenol substitute to be combined with zinc oxide. Olive oil is a vegetable oil that comprises antioxidants, carotenoids, oleuropein, and oleocanthal, a phenolic component that significantly contributes to its antibacterial and anti-inflammatory properties. ozone in the form of ozonated olive oil, have the ability to produce nascent oxygen deep into the treated area without triggering irritation so, improved rheological characteristics, increased intracellular ATP, stimulated cellular metabolism, and expression of cytokines related to healing, particularly Transforming Growth Factor.

Enrollment: 90 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy & cooperative child
• history of spontaneous pain
• Percussion sensitivity
• presence of inter-radicular or periapical radiolucency
• No internal root resorption
• External root resorption limited to apical third and with at least two-thirds root intact.

Exclusion criteria

• Uncooperativeness of child and/or parents
• Unrestorable tooth
• Presence of calcific metamorphosis inside root canals
• Tooth with evidence of extensive internal/external pathological root resorption.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

group 1: zinc oxide-ozonated olive oil

Experimental group

Description:

Group I: 30 primary molars were filled with fresh mix of zinc oxide powder with ozonated olive oil A single-visit pulpectomy procedure was performed . Standardized preoperative periapical radiograph was obtained to assess tooth condition \& proper selection. Teeth were anesthetized \& Rubber dam isolation was done, then all caries was removed \& access opening was gained. Working length was determined by apex locator. All canals were prepared using Kidzo file system in a lateral brushing motion with an Endo-Mate DT endodontic motor at 350 RPM and 2.5 N/cm torque. EDTA gel 17% will be used before instrumentation \& irrigation was done with normal saline. Dryness with paper points size 30 . placement of the root canal filling material (zinc oxide-ozonated olive oil) was applied . Intermediate restorative material was placed, then tooth was restored with stainless-steel crown

Treatment:

Radiation: radiographic evaluation

Procedure: pulpectomy procedure and the clinical evaluation

group 2: zinc oxide- olive oil

Experimental group

Description:

Group 2: 30 primary molars were filled with fresh mix of zinc oxide powder with olive oil A single-visit pulpectomy procedure was performed . Standardized preoperative periapical radiograph was obtained to assess tooth condition \& proper selection. Teeth were anesthetized \& Rubber dam isolation was done, then all caries was removed \& access opening was gained. Working length was determined by apex locator. All canals were prepared using Kidzo file system in a lateral brushing motion with an Endo-Mate DT endodontic motor at 350 RPM and 2.5 N/cm torque. EDTA gel 17% will be used before instrumentation \& irrigation was done with normal saline. Dryness with paper points size 30 . placement of the root canal filling material (zinc oxide- olive oil) was applied . Intermediate restorative material was placed, then tooth was restored with stainless-steel crown

Treatment:

Radiation: radiographic evaluation

Procedure: pulpectomy procedure and the clinical evaluation

group 3:zinc oxide- eugenol

Active Comparator group

Description:

Group 3: 30 primary molars were filled with zinc oxide- eugenol A single-visit pulpectomy procedure was performed . Standardized preoperative periapical radiograph was obtained to assess tooth condition \& proper selection. Teeth were anesthetized \& Rubber dam isolation was done, then all caries was removed \& access opening was gained. Working length was determined by apex locator. All canals were prepared using Kidzo file system in a lateral brushing motion with an Endo-Mate DT endodontic motor at 350 RPM and 2.5 N/cm torque. EDTA gel 17% will be used before instrumentation \& irrigation was done with normal saline. Dryness with paper points size 30 . placement of the root canal filling material (zinc oxide- eugenol) was applied . Intermediate restorative material was placed, then tooth was restored with stainless-steel crown

Treatment:

Radiation: radiographic evaluation

Procedure: pulpectomy procedure and the clinical evaluation