NCT05633537

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

Clinical and Radiographic Evaluation of Zinc Oxide-Ozonated Oil as a New Root Canal Filling Material for Primary Molars

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Pulp Disease, Dental
• Obturation
• Root Canal Infection

Interventions

Type	Name	Description
PROCEDURE	pulpectomy procedure and the clinical evaluation	in this study, pulpectomy procedure was performed in a single visit and the root canals were filled with different obturating materials. The clinical follow up evaluation was carried out after three, six and twelve months after pulpectomy procedures. The teeth were clinically evaluated each follow up visit for the following clinical features: absence of spontaneous pain, no tenderness with percussion, no abnormal mobility and absence of swelling \& sinus or fistula. If the tooth exhibited any one of above clinical features, the pulpectomy was considered to be a failure (F); otherwise, it was regarded as clinical success (S).
RADIATION	radiographic evaluation	Radiographic evaluation was performed immediately after teeth restoration (base line radiograph), then after three, six and twelve months. The parallel periapical technique was performed using the rinn (XCP) periapical film holder and a long cone which was mounted to the x-ray tube. The criteria for radiographic success were no evidence of extensive pathologic root resorption, reduction or no change in pre-operative pathologic inter-radicular radiolucency and no evidence of new postoperative pathologic radiolucency.

Timeline

• Start date: 2021-07-04
• Primary completion: 2023-03-01
• Completion: 2023-05-29
• First posted: 2022-12-01
• Last updated: 2023-12-07

Locations

1 site across 1 country: Egypt