NCT05040620

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2020

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

November 15, 2020

Last Update Submit

September 3, 2021

Conditions

Keywords

Orthodontic tooth movement, olive oil

Outcome Measures

Primary Outcomes (1)

  • The duration of orthodontic teeth aligning using Little irregualrity index

    To detect the effect of local usage of Olive Oil on orthodontic brackets during the alignment phase of orthodontic treatment in changing the Little's irregularity in- dex.

    4 months

Secondary Outcomes (1)

  • orthodontic wire surface roughness changes

    one month

Study Arms (2)

Placebo

NO INTERVENTION

controlling group who will receive traditional orthodontic treatment.

Olive Oil

EXPERIMENTAL

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

Drug: Olive Oil Topical Oil

Interventions

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

Also known as: olive oil
Olive Oil

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Nasef

Minya, 61111, Egypt

RECRUITING

Related Publications (9)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Interventions

Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ahmed Nasef, lecturer

    lecturer of orthodontics, Minia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Nasef, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Orthodontics, Faculty of Dentistry, Minia University, Egypt

Study Record Dates

First Submitted

November 15, 2020

First Posted

September 10, 2021

Study Start

January 1, 2020

Primary Completion

March 30, 2022

Study Completion

May 1, 2022

Last Updated

September 10, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

planning not to share study methodology until finishing the study

Locations