MalocclusionNCT04968327
Micro-osteoperforations on the Rate of Canine Retraction
A study testing Micro-osteoperforations (MOPs) and Conventional canine retraction in people with Malocclusion, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
the study aimed to clinically evaluate the effect of micro-osteoperforations on the rate of tooth movement, as evaluated by its effect on the rate of canine retraction. Read more about this study
- Who is it for?
- Ages 15 to 20 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- Micro-osteoperforations (MOPs) and Conventional canine retraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 30 Aug 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- healthy systemic condition with no chronic diseases
- no previous orthodontic treatment
- adequate oral hygiene
- have a healthy periodontium
- signed an informed consent
Who cannot join
- have a chronic disease
- previous orthodontic treatment
- poor oral hygiene or periodontal conidition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Micro-osteoperforations on the Rate of Canine Retraction; A Split-mouth Randomized Controlled Clinical Trial
the study aimed to clinically evaluate the effect of micro-osteoperforations on the rate of tooth movement, as evaluated by its effect on the rate of canine retraction.
Read the detailed description
Ten adult patients requiring maxillary first premolars' extraction were enrolled in this split-mouth randomized controlled clinical trial.
Micro-osteoperforations were randomly assigned to one side of the maxillary arch at the canine-premolar region, and the contralateral side served as the control.
Mini-screws were used for anchorage reinforcement, and canine retraction was performed using nickel-titanium closed coil springs, delivering a force of 150 grams per side.
The primary outcome was the measurement of canine retraction rate throughout the study period from digital dental models obtained every 3 weeks.
The secondary outcome was the detection of possible canine tipping during retraction.
- Conditions
- Malocclusion
- Being tested
- Micro-osteoperforations (MOPs), Conventional canine retraction
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-osteoperforations (MOPs)Other
MOPs included shallow perforations of the buccal cortical plate surrounding the tooth that requires orthodontic tooth movement, with no flap reflection was performed using a surgical bur using the special calibrated device called PROPEL
Conventional canine retractionOther
using nickel-titanium (NiTi) closed coil-springs delivering a force of 150 grams per side
| Study group | Role | What they receive |
|---|---|---|
| Micro-osteoperforations | Experimental | Not described Receives: Other: Micro-osteoperforations (MOPs); Other: Conventional canine retraction |
| Canine retraction | Active comparator | Not described Receives: Other: Conventional canine retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of canine retraction
measurements were recorded from digital dental models every 3 weeks
Measured: 12 weeks
Secondary outcomes (1)
Measurment of canine tipping
Tipping of the maxillary canine during retraction was also evaluated from digital dental models
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Jan 2017
- Primary completion18 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split-mouth
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968327
- Sponsor's protocol ID
- Canine retraction2020
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Micro-osteoperforations on the Rate of Canine Retraction; A Split-mouth Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04968327
- Acronym / sponsor ID
- Canine retraction2020
- Conditions
- Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 20 Jul 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 study aimed to clinically evaluate the effect of micro-osteoperforations on the rate of tooth movement, as evaluated by its effect on the rate of canine retraction.
Detailed description
Ten adult patients requiring maxillary first premolars' extraction were enrolled in this split-mouth randomized controlled clinical trial.
Micro-osteoperforations were randomly assigned to one side of the maxillary arch at the canine-premolar region, and the contralateral side served as the control.
Mini-screws were used for anchorage reinforcement, and canine retraction was performed using nickel-titanium closed coil springs, delivering a force of 150 grams per side.
The primary outcome was the measurement of canine retraction rate throughout the study period from digital dental models obtained every 3 weeks.
The secondary outcome was the detection of possible canine tipping during retraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- split-mouth
| Arm | Type | Receives |
|---|---|---|
| Micro-osteoperforations | Experimental | Other: Micro-osteoperforations (MOPs), Other: Conventional canine retraction |
| Canine retraction | Active comparator | Other: Conventional canine retraction |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- healthy systemic condition with no chronic diseases
- no previous orthodontic treatment
- adequate oral hygiene
- have a healthy periodontium
- signed an informed consent
Key exclusion criteria (3 listed)
- have a chronic disease
- previous orthodontic treatment
- poor oral hygiene or periodontal conidition
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 |
|---|---|---|
| Micro-osteoperforations (MOPs)MOPs included shallow perforations of the buccal cortical plate surrounding the tooth that requires orthodontic tooth movement, with no flap reflection was performed using a surgical bur using the special calibrated device called PROPEL | Other | Micro-osteoperforations |
| Conventional canine retractionusing nickel-titanium (NiTi) closed coil-springs delivering a force of 150 grams per side | Other | Canine retraction, Micro-osteoperforations |
Primary outcome
Rate of canine retraction
Time frame: 12 weeks
measurements were recorded from digital dental models every 3 weeks
1 secondary outcome
Measurment of canine tipping
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
Related trials for Malocclusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-osteoperforations (MOPs) and Conventional canine retraction in people with Malocclusion, run by Hams Hamed Abdelrahman 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 20 Jul 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of canine retraction (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2021.