Orthodontic Tooth MovementPhase 1NCT05040620
Effectiveness of Olive Oil Local Application in Orthodontic Patients.
A Phase 1 study testing Olive Oil Topical Oil in people with Orthodontic Tooth Movement, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Tooth Movement
- What is being tested?
- Olive Oil Topical Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Nasef
Minya, 61111
Ahmed Nasef, lecturer, 002-01003383457, a.nasef_ortho@hotmail.com
Asmaa Mahmoud, lecturer, 002-01002966412, dentistasmaa_biology@hotmail.com
About this study
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.
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.
Read the 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.
- Conditions
- Orthodontic Tooth Movement
- Being tested
- Olive Oil Topical Oil
- Keywords
- Orthodontic tooth movement, olive oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive Oil Topical OilDrug
Also called olive oil
the effect of olive oil local application in decreasing orthodontic alighment phase
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Olive Oil Topical Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
orthodontic wire surface roughness changes
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Jan 2020
- Primary completion30 Mar 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Tooth MovementStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Nasef Abdelhameed, Minia University
- Investigators
- Ahmed Nasef, lecturer, Principal investigator, lecturer of orthodontics, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040620
- Sponsor's protocol ID
- 455
- Status last verified
- Sep 2021
- First submitted
- 15 Nov 2020
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: planning not to share study methodology until finishing the study
Publications
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.
PubMed 19413397Chimenti 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.
PubMed 15898384Carrion-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.
PubMed 26438988Matarese 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.
PubMed 18456144Yanase 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.
PubMed 24160997Gorzynik-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.
PubMed 29495598Gotsis 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.
PubMed 24778424Curto 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.
PubMed 32423007Little 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.
PubMed 1059332
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05040620
- Acronym / sponsor ID
- 455
- Conditions
- Orthodontic Tooth Movement
- Keywords
- Orthodontic tooth movement, olive oil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –controlling group who will receive traditional orthodontic treatment. |
| Olive Oil | Experimental | Drug: Olive Oil Topical Oilexperimental group who will receive the local application of Olive Oil five times daily after teeth brushing |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive Oil Topical OilAlso: olive oilthe effect of olive oil local application in decreasing orthodontic alighment phase | Drug | Olive Oil |
Primary outcome
The duration of orthodontic teeth aligning using Little irregualrity index
Time frame: 4 months
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.
1 secondary outcome
orthodontic wire surface roughness changes
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Results publication: PubMed 19413397Ehsani 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.
- Results publication: PubMed 15898384Chimenti 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.
- Results publication: PubMed 26438988Carrion-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.
- Results publication: PubMed 18456144Matarese 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.
- Results publication: PubMed 24160997Yanase 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.
- Results publication: PubMed 29495598Gorzynik-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.
- Results publication: PubMed 24778424Gotsis 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.
- Results publication: PubMed 32423007Curto 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.
- Results publication: PubMed 1059332Little 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.
- Individual participant dataSharing planned: No. planning not to share study methodology until finishing the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Nasef, lecturer principal investigator
lecturer of orthodontics, Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olive Oil Topical Oil in people with Orthodontic Tooth Movement, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Nasef, lecturer (002-01003383457, a.nasef_ortho@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of orthodontic teeth aligning using Little irregualrity index (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05040620, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.