Clinical trial NCT05040620: Effectiveness of Olive Oil Local Application in Orthodontic Patients.
Official title: Effectiveness of Olive Oil Local Application in Decreasing the Period of Alignment Phase in Non Extraction Orthodontic Patients. A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Orthodontic Tooth Movement
Keywords: Orthodontic tooth movement, olive oil
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 110
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The large body of evidence supports the chemotherapeutic potential of substances found in Olive Oil (OO), acting on different sides, such as inflammation, oxidative damage, and even epigenetic modulation. The consumption of OO should be suggested in a healthy diet instead of other types of oils. It looks worthy, to determine the effect of local application of Olive Oil in decreasing the friction between brackets and wires during orthodontic treatment.

Detailed description: During the orthodontic treatment, the friction between the bracket and the arch-wire could prevent the action of forces required for a particular tooth movement. Studies demonstrated that approximately 12 to 60% of the force used to move a tooth is dissipated in the form of friction. Consequently, a delay could occur in the biological response to orthodontic movement. The most important factors that may have an impact on friction are; the composition of the bracket, the arch-wire alloy, the cross-sectional size of the arch-wire, the type of ligation system and the surface roughness of the bracket-archwire assembly.

In addition to the factors related to the orthodontic appliances, saliva is considered to be a biological variable associated with friction, as it acts as a lubricant during sliding mechanics.This fact should be taken into account in laboratory studies that aim to evaluate the performance of the archwire-bracket combinations. However, in the majority of the research studies, the friction test has been conducted without the use of any lubricant, which does not represent the clinical reality where there is saliva introduced during the movement of the arch-wire on the bracket. To remedy this situation, distilled water has been used as a lubricant. Although in this case the test is conducted in the presence of a lubricant, water does not have the lubricating ability of natural human saliva.

It is well known that oil is a well-known lubricant. But how we can use it to decrease friction between brackets and wires? and which type of oil we can use safely in patient mouth? Olive oil (OO) (Olea europaea, Oleaceae) is a fundamental component of the Mediterranean Diet; it is a mix of fatty acids such as oleic and linoleic acid, secoiridoids (oleuropein and oleocanthal), simple phenols (tyrosol and hydroxytyrosol), lignans (pinoresinol), flavonoids (apigenin), hydrocarbons (squalene), triterpenes (maslinic acid), and phytosterols (β-sitosterol).

The large body of evidence supports the chemotherapeutic potential of substances found in OO, acting on different sides, such as inflammation, oxidative damage, and even epigenetic modulation. The consumption of OO should be suggested in a healthy diet instead of other types of oils. It looks worthy, to determine the effect of local application of Olive Oil in decreasing the friction between brackets and wires during orthodontic treatment.

Eligibility criteria: Inclusion Criteria:

1. The age of patients ranges from 15-20 years old.
2. Mild to moderate dental irregularity requiring non-extraction treatment.
3. Presence of all the permanent teeth at least up to the first molars.
4. Good oral hygiene, and periodontal health.

Exclusion Criteria:

1. Patients require orthognathic surgery to correct skeletal discrepancies.
2. patients who are taking medications, like NSAIDs or other anti-inflammatory drugs.
3. cleft lip or palate patients.
4. patients with hypodontia, or hyperdontia.

Primary outcomes:
measure: The duration of orthodontic teeth aligning using Little irregualrity index
timeFrame: 4 months
Secondary outcomes:
measure: orthodontic wire surface roughness changes
timeFrame: one month
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Ahmed Nasef
Study officials:
affiliation: lecturer of orthodontics, Minia University
name: Ahmed Nasef, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ehsani S, Mandich MA, El-Bialy TH, Flores-Mir C. Frictional resistance in self-ligating orthodontic brackets and conventionally ligated brackets. A systematic review. Angle Orthod. 2009 May;79(3):592-601. doi: 10.2319/060208-288.1.
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citation: Curto A, Albaladejo A, Montero J, Alvarado A. Influence of a Lubricating Gel (Orthospeed(R)) on Pain and Oral Health-Related Quality of Life in Orthodontic Patients during Initial Therapy with Conventional and Low-Friction Brackets: A Prospective Randomized Clinical Trial. J Clin Med. 2020 May 14;9(5):1474. doi: 10.3390/jcm9051474.
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