Dental MalocclusionNCT04631419
Effects of Flapless Laser Corticotomy in Canine Retraction
A study testing Flapless laser corticotomy and Canine retraction in people with Dental Malocclusion and Bimaxillary Protrusion, run by Suez Canal University at 1 site in Egypt.
Trial summary
This study is conducted to evaluate the effects of flapless laser corticotomy on the rate of canine retraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Malocclusion, Bimaxillary Protrusion
- What is being tested?
- Flapless laser corticotomy and Canine retraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 30 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Full complement of teeth with no congenitally missing teeth except 3rd molars.
- Minor or no crowding cases requires four premolars extraction, canine retraction \& maximum anchorage with bimaxillary dentoalveolar protrusion.
- No history of previous orthodontic treatment
- Clinically healthy patients with no history of drug intake and\or no history for any systemic illness, syndromes, craniofacial deformities.
- Vital teeth with normal periodontium and no root resorption.
- Adequate oral hygiene; probing depth values not exceeding 3 mm across the entire dentition; adequate thickness of the attached gingiva (1-2 mm).
- No radiographic evidence of bone loss.
Who cannot join
- Systemic disease that might have affected bone formation or density, such as osteoporosis, hyperparathyroidism, or vitamin D deficiency.
- Presence of any local or systemic surgical contraindication.
- Extracted or missing permanent tooth/teeth except for 3rd molars.
- Facial asymmetry
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Orthodontic department , Faculty of dentistry , Suez Canal University
Ismailia
About this study
Official title: Effects of Flapless Laser Corticotomy in Canine Retraction: A Randomized Controlled Trial
This study is conducted to evaluate the effects of flapless laser corticotomy on the rate of canine retraction.
- Conditions
- Dental Malocclusion, Bimaxillary Protrusion
- Being tested
- Flapless laser corticotomy, Canine retraction
- Keywords
- Flapless laser corticotomy, 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.
Flapless laser corticotomyOther
The flapless laser corticotomy will be done by Er, Cr: YSGG laser as a series of circular holes will be made along with the planned position. The depth of laser cutting will be measured and controlled continuously during the operation by the periodontal probe with stopper read to each 3mm depth in addition to a few parts of a millimetre depth into the medullary bone to enhance bleeding. Canine retraction will be started after this procedure.
Canine retractionOther
canine retraction will be done on 17x25 stst archwire using coil spring adjusted to 150 gm, and miniscrews will be used as an indirect method of anchorage reinforcement
| Study group | Role | What they receive |
|---|---|---|
| Maxillary flapless laser corticotomy group | Experimental | Flapless laser corticotomy will randomly be assigned to one side of the 14 maxillary arches (experimental side) before canine retraction. Receives: Other: Flapless laser corticotomy; Other: Canine retraction |
| Maxillary control group | Active comparator | Canine retraction will be done on the other side without Laser corticotomy . Receives: Other: Canine retraction |
| Mandibular flapless laser corticotomy group | Experimental | Flapless laser corticotomy will randomly be assigned to one side of the 14 mandibular arches (experimental side) before canine retraction. Receives: Other: Flapless laser corticotomy; Other: Canine retraction |
| Mandibular control group | Active comparator | Canine retraction will be done on the other side without Laser corticotomy . Receives: Other: Canine retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of canine retraction.
distal movement of the canine , measurement unit mm divided by time unit month , using scanned digital models
Measured: 3 months of canine retraction , distance (mm) moved by the canine distally per month
Secondary outcomes (5)
Canine rotation
rotation of canine measured in degrees , after 3 months of canine retraction using scanned digital models
Measured: 3 months, assessed at the beginning of treatment (base line ), and at the end of 3 months of canine retraction
First molar anchorage loss
mesial movement of first molar measured in mm , after 3 months of canine retraction using scanned digital models
Measured: 3 months, assessed immediately before canine retraction and at the end of 3 months of canine retraction
Root resorption
canine root length measured in mm using cone beam CT scans
Measured: 3 months , assessed at the beginning of treatment (base line ), and at the end of 3 months of canine retraction
Periodontal condition
assessed using periodontal probe to measure : probing depth in mm
Measured: 3 months , immediately before canine retraction , and at the end of 3 months of canine retraction
Pulp vitality
assessed using thermal (Cold ) test , by application of dry cotton sprayed with ethyl chloride
Measured: 3 months, assessed immediately before canine retraction , and at the end of 3 months of canine retraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Jun 2018
- Primary completion1 Dec 2020
- Study completion30 Dec 2020
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 Suez Canal 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
- Model description
- The 14 patients maxillary and mandibular arches will be allocated into a split-mouth design, so the sample will be set up each patient to act as his/her own control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abubakr Reda Fadeel Ali Bakr, Suez Canal University
- Investigators
- Abubakr R Bakr, Msc Assistan lecturer, Principal investigator, Faculty of dentistry , Suez canal university , Ismailia , Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631419
- Sponsor's protocol ID
- Flapless Laser Corticotomy
- Status last verified
- Oct 2022
- First submitted
- 30 Oct 2020
- Last updated
- 1 Nov 2022
- 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 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flapless Laser Corticotomy in Canine Retraction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04631419
- Acronym / sponsor ID
- Flapless Laser Corticotomy
- Conditions
- Dental Malocclusion, Bimaxillary Protrusion
- Keywords
- Flapless laser corticotomy, Canine retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 17 Nov 2020 (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.
This study is conducted to evaluate the effects of flapless laser corticotomy on the rate of canine retraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The 14 patients maxillary and mandibular arches will be allocated into a split-mouth design, so the sample will be set up each patient to act as his/her own control
| Arm | Type | Receives |
|---|---|---|
| Maxillary flapless laser corticotomy group | Experimental | Other: Flapless laser corticotomy, Other: Canine retractionFlapless laser corticotomy will randomly be assigned to one side of the 14 maxillary arches (experimental side) before canine retraction. |
| Maxillary control group | Active comparator | Other: Canine retractionCanine retraction will be done on the other side without Laser corticotomy . |
| Mandibular flapless laser corticotomy group | Experimental | Other: Flapless laser corticotomy, Other: Canine retractionFlapless laser corticotomy will randomly be assigned to one side of the 14 mandibular arches (experimental side) before canine retraction. |
| Mandibular control group | Active comparator | Other: Canine retractionCanine retraction will be done on the other side without Laser corticotomy . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Full complement of teeth with no congenitally missing teeth except 3rd molars.
- Minor or no crowding cases requires four premolars extraction, canine retraction \& maximum anchorage with bimaxillary dentoalveolar protrusion.
- No history of previous orthodontic treatment
- Clinically healthy patients with no history of drug intake and\or no history for any systemic illness, syndromes, craniofacial deformities.
- Vital teeth with normal periodontium and no root resorption.
Key exclusion criteria (4 listed)
- Systemic disease that might have affected bone formation or density, such as osteoporosis, hyperparathyroidism, or vitamin D deficiency.
- Presence of any local or systemic surgical contraindication.
- Extracted or missing permanent tooth/teeth except for 3rd molars.
- Facial asymmetry
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 |
|---|---|---|
| Flapless laser corticotomyThe flapless laser corticotomy will be done by Er, Cr: YSGG laser as a series of circular holes will be made along with the planned position. The depth of laser cutting will be measured and controlled continuously during the operation by the periodontal probe with stopper read to each 3mm depth in addition to a few parts of a millimetre depth into the medullary bone to enhance bleeding. Canine retraction will be started after this procedure. | Other | Mandibular flapless laser corticotomy group, Maxillary flapless laser corticotomy group |
| Canine retractioncanine retraction will be done on 17x25 stst archwire using coil spring adjusted to 150 gm, and miniscrews will be used as an indirect method of anchorage reinforcement | Other | Mandibular control group, Mandibular flapless laser corticotomy group, Maxillary control group, Maxillary flapless laser corticotomy group |
Primary outcome
Rate of canine retraction.
Time frame: 3 months of canine retraction , distance (mm) moved by the canine distally per month
distal movement of the canine , measurement unit mm divided by time unit month , using scanned digital models
5 secondary outcomes
Canine rotation
Time frame: 3 months, assessed at the beginning of treatment (base line ), and at the end of 3 months of canine retraction
First molar anchorage loss
Time frame: 3 months, assessed immediately before canine retraction and at the end of 3 months of canine retraction
Root resorption
Time frame: 3 months , assessed at the beginning of treatment (base line ), and at the end of 3 months of canine retraction
Periodontal condition
Time frame: 3 months , immediately before canine retraction , and at the end of 3 months of canine retraction
Pulp vitality
Time frame: 3 months, assessed immediately before canine retraction , and at the end of 3 months of canine retraction
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 1 Nov 2022.
- Acceleration of canine movement by laser assisted flapless corticotomy \[An innovative approach in clinical orthodonticsLink provided by the sponsor.
- Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trialLink provided by the sponsor.
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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.
Abubakr R Bakr, Msc Assistan lecturer principal investigator
Faculty of dentistry , Suez canal university , Ismailia , Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flapless laser corticotomy and Canine retraction in people with Dental Malocclusion and Bimaxillary Protrusion, run by Suez Canal 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 7 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 1 Nov 2022. 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: 3 months of canine retraction , distance (mm) moved by the canine distally per month). 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 1 Nov 2022.