Effectiveness of Olive Oil Local Application in Decreasing the Period of Alignment Phase in Non Extraction Orthodontic Patients. A Randomized Controlled Clinical Trial.
Phase: PHASE1
Conditions: Orthodontic Tooth Movement
Sponsor: Minia University

Effectiveness of Olive Oil Local Application in Decreasing the Period of 
Alignment Phase in Non Extraction Orthodontic Patients. A Randomized 
Controlled Clinical Trial. 
 
Ahmed Nasef Abdelhameed 
Lecturer of Orthodontics, Faculty of Dentistry, Minia University, Egypt 
 
 
  Background: 
During the orthodontic treatment, the friction between the bracket and the archwire could 
prevent the action of forces required for a particular tooth movement (1). Studies demonstrated 
that approximately 12 to 60% of the force used to move a tooth is dissipated in the form of 
friction (2). 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 archwire alloy, the cross-sectional size of the arch-wire, the 
type of ligation system and the surface roughness of the bracket-archwire assembly (3,4). 
 
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 (5) 
.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 (6,7,8,9) , which does 
not represent the clinical reality where there is saliva introduced during the movement of the 
archwire on the bracket. To remedy this situation, distilled water has been used as a lubricant 
(10) . 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 (11,12). 
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) (13,14). 
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 (15,16).  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. 
Aim & objectives:  
Primary outcome: 
To detect the effect of local usage of Olive Oil on orthodontic brackets during the alignment 
phase of orthodontic treatment in decreasing the duration of teeth alignment. 
 

Secondary outcome: 
To examine the change in surface roughness of Nickel-Titanium and stainless steel archwires 
when using Olive Oil as a lubricant and without usage of a lubricant.   
Study Design: 
A Randomized Controlled Clinical Trial will be performed according to CONSORT guidelines  
Selection and Exclusion of Subjects: 
Patients who will be enrolled in this study should have the following 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.  
5. Patients will be excluded if they require orthognathic surgery to correct skeletal 
discrepancies, were taking medications, like NSAIDs or other anti-inflammatory drugs, 
had cleft lip or palate, hypodontia, or hyperdontia. 
Ethical Regulations: 
Written consent forms will be obtained after informing the patients and/or their parents of the 
interventions and the possible effects associated with them. 
 Ethics approval for this clinical trial was obtained from the Ethics Committee of Faculty of 
Dentistry, Minia University  
Treatment Subjects: 
Sample size calculation was performed using power (sample size) calculator online software 
according to the formula for Superiority Trials with continuous outcomes with a margin of 
error of 5% and a confidence level of 90%, and the mean outcome difference obtained from 
previous similar published trials (17,18). The target sample size was determined to be 110 
patients, including 10% dropout.  
Assessment of Efficacy: 
Little’s irregularity index (19) will be used to assess the changes in dental alignment throughout 
the study. All the measurements will be made on the study models reproduced from alginate 
impressions that will be taken for both arches: immediately before brackets bonding(T0), after 
one month(T1), after two months(T2), after three months(T3), and after four months(T4). All 
measurements will be done using an electronic digital caliper (Dentaurum, Inspringen, 
Germany) with an accuracy of 0.01 mm.  
Scanning electron microscopic images will be taken for the NiTi wires that will be used for 
teeth alignment to assess the changes in surface roughness of these wires. 
   
 

Adverse Events: 
Any adverse effects that will be noticed or reported from patients resulting from Olive Oil 
usage will be reported.  
Statistical analysis plan: 
The means and standard deviations (mean ± SD) of the quantitative variables will be used to 
describe the relevant variables in the sample. Descriptive statistics (means, standard deviations, 
and percentages) will be calculated using SPSS v-20 (SPSS Inc., Chicago, IL, USA). Also 
inferential statistics in form of student’s t-test and repeated-measurements analysis, with the 
significance level of 0.05, will be used to analyze the outcome measurements. 
Data management: 
The data will be analyzed to get the statistical and clinical significance.  
 Project Timetable Flowchart:   
 
 
 
 
 
 
 
 
  
 
 
Figure (1): CONSORT Flow Diagram 
 
 
Enrollment 
 110 patients 
Allocation 
Control Group (55 
patients): No Olive 
oil local application 
Experimental Group 
(55 patients): Olive 
oil local application 
Follow Up 
Lost to follow up (give reasons) (no=) 
Discontinued intervention (give reasons) 
(no=) 
Lost to follow up (give reasons) (no=) 
Discontinued intervention (give reasons) 
(no=) 
Analysis 
Analyzed (give reasons) (no=) 
Excluded from analysis (give reasons) 
(no=) 
Analyzed (give reasons) (no=) 
Excluded from analysis (give reasons) 
(no=) 

References: 
1. 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. 
2. Chimenti C, Franchi L, Di Giuseppe MG, M Lucci M. Friction of orthodontic elastomeric 
ligatures with different dimensions. Angle Orthod. 2005 May;75(3):421-5. 
3. Crincoli V, Perillo L, Di Bisceglie MB, Balsamo A, Serpico V, Chiatante F, et al. Friction 
forces during sliding of various brackets for malaligned teeth: an in vitro study. Sci World J. 
2013;2013:871423.   
4. 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.   
5. Pacheco MR, Jansen WC, Oliveira DD. The role of friction in orthodontics. Dental Press J 
Orthod. 2012 Mar-Apr;17(2):170-7.   
6. Matarese G, Nucera R, Militi A, Mazza M, Portelli M, Festa F, et al. 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.   
7. Lombardo L, Wierusz W, Toscano D, Lapenta R, Kaplan A, Siciliani G. Frictional resistance 
exerted by different lingual and labial brackets: an in vitro study. Prog Orthod. 2013 Oct;14:37. 
  
8. Tecco S, Di Lorio D, Nucera R, Di Bisceglie B, Cordasco G, Festa F. Evaluation of the friction 
of self-ligating and conventional bracket systems. Eur J Dent. 2011 Winter;5(3):310-7.  
9. 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.  
10. Ribeiro AA, Mattos CT, Ruellas AC, Araújo MT, Elias CN. In vivo comparison of the friction 
forces in new and used brackets. Orthodontics (Chic.) 2012;13(1):e44-50.  
11. Al-Mansouri N, Palmer G, Moles DR, Jones SP. The effects of lubrication on the static 
frictional resistance of orthodontic brackets. Aust Orthod J. 2011 Nov;27(2):132-8.  
12. Leal RC, Amaral FL, França FM, Basting RT, Turssi CP. Role of lubricants on friction between 
self-ligating brackets and archwires. Angle Orthod. 2014 Nov;84(6):1049-53.  
13. Fernandez, A.G.; Adams, M.R.; Fernandez-Diez, M.J. Table Olives: Production and 
Processing; Springer:  New York, USA, 1997; ISBN 978-0-412-71810-6.   
14. 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, 19, 686.   
15. Benavente-Garcıa, O.; Castillo, J.; Lorente, J.; Ortuno, A.; del Rio, J. Antioxidant activity of 
phenolics extracted from Olea europaea L. leaves. Food Chem. 2000, 68, 457–462.  
16. 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, 
66, 304–318.  
17. Arezoo Jahanbin, Nadia Hasanzadeh, Sara Khaki, Hooman Shafaee. Comparison of self-
ligating Damon3 and conventional MBT brackets regarding alignment efficiency and pain 
experience: A randomized clinical trial. J Dent Res Dent Clin Dent Prospects. 2019 
Fall;13(4):281-288. doi: 10.15171/joddd.2019.043. 
18. Curto A, Albaladejo A, Montero J, Alvarado A. Influence of a Lubricating Gel (Orthospeed®) 
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. 
19. Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J 
Orthod. 1975;68(5):554-63.   
  

Supplements/Appendices  : 
Informed Consent Form 
 
Personal Data: 
Patient Name:  
Age:  
Address:  
Mobile NO.: 
  
Research Title:  
Effectiveness of Olive Oil Local Application in Decreasing the Period of Alignment Phase in Non Extraction 
Orthodontic Patients. A Randomized Controlled Clinical Trial.  
 
Aim of the Research:  
Primary outcome:  
To detect the effect of local usage of Olive Oil on orthodontic brackets during the alignment phase of orthodontic 
treatment in decreasing the duration of teeth alignment.  
Secondary outcome:  
To examine the change in surface roughness of Nickel-Titanium and stainless steel arch-wires when using Olive 
Oil as a lubricant and without usage of a lubricant.  
 
Volunteer Returned on Benefits:  
The Volunteer will get all the orthodontic treatment for free.  
 
Expected Side Effects of the treatment:  
Regarding the Olive oil, no side effects are expected as the consumption of Olive Oil is suggested in a healthy 
diet instead of other types of oils.  
While regarding the common side effects of orthodontic treatment are pain and ulcerations. Responsible 
Doctor: Ahmed Nasef, Lecturer of Orthodontics, Faculty of Dentistry, Minia University. Mobile No.: 
01003383457  
 
Volunteer Signature:                                                                                                 Doctor Signature: