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NCT Number: NCT05633537

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

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.

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Key information

Conditions

Pulp Disease, Dental Bites and Stings Chemically-Induced Disorders Dental Pulp Diseases Obturation Poisoning Root Canal Infection Stomatognathic Diseases Tooth Diseases Wounds and Injuries

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Gharbia Governorate, 6624033, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pulpectomy procedure and the clinical evaluation

Procedure

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).

Other names: clinical evaluation of root canal treatment of primary molars

Radiographic Evaluation

Radiation

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.

Primary outcomes

  1. clinical success of primary molar pulpectomy after using new root canal filling materials (Zinc Oxide-Ozonated olive Oil , Zinc Oxide- olive Oil) compared to the widely used material (zinc oxide material)

    Time frame: 12 months

    by assessing the presence or absence of spontaneous pain, presence or absence of tenderness with percussion, presence or absence of abnormal mobility and presence or absence of swelling and/or fistula during the follow-up intervals ( three, six and twelve months )

  2. radiographic success of primary molar pulpectomy after using new root canal filling materials (Zinc Oxide-Ozonated olive Oil , Zinc Oxide- olive Oil) compared to the widely used material (zinc oxide material)

    Time frame: 12 months

    by assessing the presence or absence of extensive pathologic root resorption, reduction or no change in pre-operative pathologic inter-radicular radiolucency and presence or absence of new postoperative pathologic radiolucency. the assessment is done using periapical radiographs at three, six and twelve months after pulpectomy procedure.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2022
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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