Dental MalocclusionNCT03906084
Evaluation of the Effect of Corticotomy and Low Level Laser Therapy on Orthodontic Tooth Movement
A study testing Corticotomy and low laser therapy and Corticotomy facilitated Orthodontics in people with Dental Malocclusion, run by Cairo University.
Trial summary
The aim of the present study was to compare, a standard efficient technique in accelerating OTM as surgical corticotomy as a gold standard versus surgical corticotomy combined with LLLT in an attempt for further acceleration of OTM. Read more about this study
- Who is it for?
- Ages 17 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Malocclusion
- What is being tested?
- Corticotomy and low laser therapy and Corticotomy facilitated Orthodontics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to May 2018
- 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 17 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Post pubertal patients with age more than 17 years.
- Class I or Class II (Angles' classification) malocclusion cases requiring 1st premolar extraction with moderate anchorage.
Who cannot join
- Patients having missing permanent canine teeth in maxillary arch.
- History of trauma or root canal treatment in maxillary canines.
- History of previous orthodontic treatment.
- History of hormonal disorder or syndrome.
About this study
Official title: Evaluation of the Combined Effect of Corticotomy and Low Level Laser Therapy on the Rate of Orthodontic Tooth Movement: Split Mouth Randomized Clinical Trial
The aim of the present study was to compare, a standard efficient technique in accelerating OTM as surgical corticotomy as a gold standard versus surgical corticotomy combined with LLLT in an attempt for further acceleration of OTM.
Read the detailed description
The study design was a randomized split mouth design to compare, clinically and radiographically, between the two interventions (Corticotomy and Laser versus Corticotomy only) by assessing the rate of maxillary canine retraction achieved in 4 months. Secondary outcomes were to evaluate 1st maxillary molar anchorage loss, changes in tipping, torque and rotations values of maxillary canine and 1st molar. In addition, the impact of both interventions on root resorption was assessed. The present study was carried on 16 female patients. All patients required maxillary 1st premolar extraction and subsequent maxillary canine retraction.
- Conditions
- Dental Malocclusion
- Being tested
- Corticotomy and low laser therapy, Corticotomy facilitated Orthodontics
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticotomy and low laser therapyProcedure or surgery
Corticotomy is carried out under local anesthesia followed by low-intensity laser therapy that is started on the selected experimental side on the same day as placement of the coil spring
Corticotomy facilitated OrthodonticsProcedure or surgery
Corticotomy is carried out under local anesthesia in right side.
| Study group | Role | What they receive |
|---|---|---|
| Corticotomy facilitated orthodontics. | Active comparator | Corticotomy is carried out under local anesthesia in right side. Receives: Procedure: Corticotomy and low laser therapy |
| Corticotomy and low level laser therapy | Experimental | Corticotomy is carried out under local anesthesia followed by low-intensity laser therapy that is started on the selected experimental side on the same day as placement of the coil spring Receives: Procedure: Corticotomy facilitated Orthodontics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of canine retraction
Rate of canine retraction using a digital caliper, units of mm, readings extracted from digital models reading each month.
Measured: 4 months
Secondary outcomes (1)
Root resorption
Root resorption using CBCT in mm after the end of canine retraction period (at the end of 4 months)
Measured: after 4 months from start of clinical trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study startApr 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental MalocclusionStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Ahmed Farid Shehab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906084
- Sponsor's protocol ID
- CEBD-CU-2015-03-17
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Combined Effect of Corticotomy and Low Level Laser Therapy on the Rate of Orthodontic Tooth Movement: Split Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03906084
- Acronym / sponsor ID
- CEBD-CU-2015-03-17
- Conditions
- Dental Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 8 Apr 2019 (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 aim of the present study was to compare, a standard efficient technique in accelerating OTM as surgical corticotomy as a gold standard versus surgical corticotomy combined with LLLT in an attempt for further acceleration of OTM.
Detailed description
The study design was a randomized split mouth design to compare, clinically and radiographically, between the two interventions (Corticotomy and Laser versus Corticotomy only) by assessing the rate of maxillary canine retraction achieved in 4 months. Secondary outcomes were to evaluate 1st maxillary molar anchorage loss, changes in tipping, torque and rotations values of maxillary canine and 1st molar. In addition, the impact of both interventions on root resorption was assessed. The present study was carried on 16 female patients. All patients required maxillary 1st premolar extraction and subsequent maxillary canine retraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticotomy facilitated orthodontics. | Active comparator | Procedure: Corticotomy and low laser therapyCorticotomy is carried out under local anesthesia in right side. |
| Corticotomy and low level laser therapy | Experimental | Procedure: Corticotomy facilitated OrthodonticsCorticotomy is carried out under local anesthesia followed by low-intensity laser therapy that is started on the selected experimental side on the same day as placement of the coil spring |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Post pubertal patients with age more than 17 years.
- Class I or Class II (Angles' classification) malocclusion cases requiring 1st premolar extraction with moderate anchorage.
Key exclusion criteria (4 listed)
- Patients having missing permanent canine teeth in maxillary arch.
- History of trauma or root canal treatment in maxillary canines.
- History of previous orthodontic treatment.
- History of hormonal disorder or syndrome.
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 |
|---|---|---|
| Corticotomy and low laser therapyCorticotomy is carried out under local anesthesia followed by low-intensity laser therapy that is started on the selected experimental side on the same day as placement of the coil spring | Procedure or surgery | Corticotomy facilitated orthodontics. |
| Corticotomy facilitated OrthodonticsCorticotomy is carried out under local anesthesia in right side. | Procedure or surgery | Corticotomy and low level laser therapy |
Primary outcome
Rate of canine retraction
Time frame: 4 months
Rate of canine retraction using a digital caliper, units of mm, readings extracted from digital models reading each month.
1 secondary outcome
Root resorption
Time frame: after 4 months from start of clinical trial
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 8 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Corticotomy and low laser therapy and Corticotomy facilitated Orthodontics in people with Dental Malocclusion, run by Cairo University.
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 2 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: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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: 4 months). 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 8 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.