Clinical trial NCT05633537: Clinical & Radiographic Evaluation of Zinc Oxide-Ozonated Oil as a New Primary Root Canal Filling
Official title: Clinical and Radiographic Evaluation of Zinc Oxide-Ozonated Oil as a New Root Canal Filling Material for Primary Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulp Disease, Dental
Obturation
Root Canal Infection
Keywords: pulpectomy
Ozonated Olive Oil
zinc oxide eugenol
primary molars
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbia
Study officials:
References:
citation: Barja-Fidalgo F, Moutinho-Ribeiro M, Oliveira MA, de Oliveira BH. A systematic review of root canal filling materials for deciduous teeth: is there an alternative for zinc oxide-eugenol? ISRN Dent. 2011;2011:367318. doi: 10.5402/2011/367318. Epub 2010 Oct 17.
citation: Chandra SP, Chandrasekhar R, Uloopi KS, Vinay C, Kumar NM. Success of root fillings with zinc oxide-ozonated oil in primary molars: preliminary results. Eur Arch Paediatr Dent. 2014 Jun;15(3):191-5. doi: 10.1007/s40368-013-0094-8. Epub 2013 Nov 6.
citation: Sarrami N, Pemberton MN, Thornhill MH, Theaker ED. Adverse reactions associated with the use of eugenol in dentistry. Br Dent J. 2002 Sep 14;193(5):257-9. doi: 10.1038/sj.bdj.4801539.
citation: Ulusoy OI, Ekici MAG, Alacam T, Bari E, Ulusoy C. Virgin Olive Oil, Soybean Oil, and Hank's Balanced Salt Solution Used as Storage Media on Periodontal Ligament Cell Viability. Pediatr Dent. 2019 Nov 15;41(6):485-488.
citation: Saini R. Ozone therapy in dentistry: A strategic review. J Nat Sci Biol Med. 2011 Jul;2(2):151-3. doi: 10.4103/0976-9668.92318.