Effectiveness of Olive Oil Local Application in Orthodontic Patients.

NCT ID: NCT05040620

Last Updated: 2021-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-05-01

Brief Summary

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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

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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.

Conditions

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Orthodontic Tooth Movement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

controlling group who will receive traditional orthodontic treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Olive Oil

experimental group who will receive the local application of Olive Oil five times daily after teeth brushing

Group Type EXPERIMENTAL

Olive Oil Topical Oil

Intervention Type DRUG

the effect of olive oil local application in decreasing orthodontic alighment phase

Interventions

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Olive Oil Topical Oil

the effect of olive oil local application in decreasing orthodontic alighment phase

Intervention Type DRUG

Other Intervention Names

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olive oil

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Nasef Abdelhameed

Lecturer of Orthodontics, Faculty of Dentistry, Minia University, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Nasef, lecturer

Role: PRINCIPAL_INVESTIGATOR

lecturer of orthodontics, Minia University

Locations

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Ahmed Nasef

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Nasef, lecturer

Role: CONTACT

002-01003383457

Asmaa Mahmoud, lecturer

Role: CONTACT

002-01002966412

Facility Contacts

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Ahmed Nasef, lecturer

Role: primary

002-01003383457

Asmaa Mahmoud, lecturer

Role: backup

002-01002966412

References

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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.

Reference Type RESULT
PMID: 19413397 (View on PubMed)

Chimenti C, Franchi L, Di Giuseppe MG, Lucci M. Friction of orthodontic elastomeric ligatures with different dimensions. Angle Orthod. 2005 May;75(3):421-5. doi: 10.1043/0003-3219(2005)75[421:FOOELW]2.0.CO;2.

Reference Type RESULT
PMID: 15898384 (View on PubMed)

Carrion-Vilches FJ, Bermudez MD, Fructuoso P. Static and kinetic friction force and surface roughness of different archwire-bracket sliding contacts. Dent Mater J. 2015;34(5):648-53. doi: 10.4012/dmj.2014-295.

Reference Type RESULT
PMID: 26438988 (View on PubMed)

Matarese G, Nucera R, Militi A, Mazza M, Portelli M, Festa F, Cordasco G. Evaluation of frictional forces during dental alignment: an experimental model with 3 nonleveled brackets. Am J Orthod Dentofacial Orthop. 2008 May;133(5):708-15. doi: 10.1016/j.ajodo.2006.06.021.

Reference Type RESULT
PMID: 18456144 (View on PubMed)

Yanase Y, Ioi H, Nishioka M, Takahashi I. Effects of sliding velocity on friction: an in vitro study at extremely low sliding velocity approximating orthodontic tooth movement. Angle Orthod. 2014 May;84(3):451-8. doi: 10.2319/060513-427.1. Epub 2013 Oct 25.

Reference Type RESULT
PMID: 24160997 (View on PubMed)

Gorzynik-Debicka M, Przychodzen P, Cappello F, Kuban-Jankowska A, Marino Gammazza A, Knap N, Wozniak M, Gorska-Ponikowska M. Potential Health Benefits of Olive Oil and Plant Polyphenols. Int J Mol Sci. 2018 Feb 28;19(3):686. doi: 10.3390/ijms19030686.

Reference Type RESULT
PMID: 29495598 (View on PubMed)

Gotsis E, Anagnostis P, Mariolis A, Vlachou A, Katsiki N, Karagiannis A. Health benefits of the Mediterranean Diet: an update of research over the last 5 years. Angiology. 2015 Apr;66(4):304-18. doi: 10.1177/0003319714532169. Epub 2014 Apr 27.

Reference Type RESULT
PMID: 24778424 (View on PubMed)

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.

Reference Type RESULT
PMID: 32423007 (View on PubMed)

Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x.

Reference Type RESULT
PMID: 1059332 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

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455

Identifier Type: -

Identifier Source: org_study_id

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