Canine RetractionLaserNCT06702956
Assessment of Dimensional Bony Changes Following Laser Corticotomy
A study testing laser corticotomy and Conventional tooth movement in people with Canine Retraction, run by Ain Shams University at 1 site in Egypt.
Trial summary
The patient's bone morphology during orthodontic treatment is an important consideration. Therefore, during orthodontic tooth movement (OTM), an imbalance between bone resorption and deposition will cause the tooth to move out of the alveolar envelope . Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Canine Retraction
- What is being tested?
- laser corticotomy and Conventional tooth movement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Oct 2024
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients who need extraction of maxillary first premolar in orthodontic treatment and patients who need canine retraction
Who cannot join
- medically compromised patient
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry , Al Azhar Univeristy For Girls
Cairo, Heliopolis - Cairo, 123456
About this study
Official title: Assessment of Dimensional Bony Changes Following Laser Corticotomy in Rapid Canine Retraction
The patient's bone morphology during orthodontic treatment is an important consideration. Therefore, during orthodontic tooth movement (OTM), an imbalance between bone resorption and deposition will cause the tooth to move out of the alveolar envelope . Unfavorable consequences like gingival recession and the dehiscence of an alveolar bone plate may arise from the movement of the teeth beyond the boundary of the bone they are housing. This happened because the dense cortical bone didn't enlarge to maintain protection for the moving root.
On the other hand, orthodontic force creates a complex loading pattern and biological response on the periodontal ligament (PDL). there was an increase in osteoclastic activity in a compression region within the PDL. In contrast, in the other tension region, there was an increase in osteoblastic activity and mineralization of the bone matrix.
Read the detailed description
Orthodontic tooth movement generates complex mechanical loading patterns with corresponding complex biological responses in the periodontal tissues. This will occur only if the hard tissue around the tooth can undergo proper breakdown and build-up . The primary trigger factor responsible for orthodontic tooth movement is the strain experienced by the periodontal ligament (PDL) cells and the extracellular matrix. This strain results in alteration in the gene expression within the cells, with a production of various cytokines and chemokines, capillary vasodilatation within periodontal ligament, and migration of inflammatory cells with more cytokine production and subsequent alveolar bone remodeling in response to mechanical loading .
On application of orthodontic force, the compression region within the PDL shows increased osteoclastic activity,whereas in the tension region, there is proliferation of osteoblasts and mineralization of the extracellular matrix . In general, molecules that have been linked to tensile strains and act by stimulating osteoblast progenitor cell proliferation in the periodontal ligament, with subsequent bone formation and inhibition of bone resorption similar to orthodontic tooth movement, include transforming growth factor-beta (TGF-b), various bone morphogenic proteins (BMPs), and epidermal growth factor (EGF) . On the other hand, Interleukin-1 beta (IL-1β), interleukin-6 (IL-6), CC chemokines ligand 2 (CCL2), and other inflammatory cytokines regulate osteoclastic activity through the activation of the nuclear factor kappa B (RANK) and the nuclear factor kappa B ligand (RANKL) .
Corticotomy for rapid tooth movement was introduced in 1959 by Köle to cut the alveolar bone and move a tooth. He practiced corticotomy and osteotomy on various malocclusion cases. Vertically, the cortical and marrow bone between the teeth were partially removed, and either a subapical horizontal cut with alveolar bone cutting at a distance of one cm. from the apex or only a cortical osteotomy excluding the marrow bone was performed .
Conventional treatment with fixed appliances likely requires an average of 1.5 to 2 years, resulting in a canine retraction rate of 0.5 to 1mm per month. Therefore, other modalities have been used to accelerate OTM such as pulsed electromagnetic field, corticotomy, dento-alveolar distraction, periodontal ligament distraction, and laser therapy Laser-based technology was a dream for oral surgery to find a new tool for bone cutting. Using of pulsed erbium-doped yttrium aluminium garnet (Er:YAG) lasers showed effective cutting tool with minimum degree of carbonization. Also, it can effectively accelerate canine retraction with no complications or discomfort for the patients. The Erbium laser affects the cortical bone, leading to RAP without postsurgical complications
- Conditions
- Canine Retraction
- Being tested
- laser corticotomy, Conventional tooth movement
- Keywords
- bony changes, laser, canine retraction, CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser corticotomyProcedure or surgery
stimulation of tooth movement during orthodontics treatment using Waterlase MDTM Turbo all-tissue laser therapy
Conventional tooth movementProcedure or surgery
tooth movement us done using wires and brackets
| Study group | Role | What they receive |
|---|---|---|
| control conventional method | Active comparator | conventional method of canine retraction using brackets Receives: Procedure: Conventional tooth movement |
| study laser corticotomy | Active comparator | an accelerated orthodontic movement using Waterlase MDTM Turbo all-tissue laser for corticotomy Receives: Procedure: laser corticotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of labial bone thickness
assessment of labial bone using CBCT
Measured: 6 months
Secondary outcomes (1)
assessment of root length
assessment of root length using CBCT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Apr 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Canine RetractionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- randomized double blinded clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zainab H Abdel Rahman, Phd, Principal investigator, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702956
- Sponsor's protocol ID
- Assessment of bony changes
- Acronym
- Laser
- Status last verified
- Oct 2024
- First submitted
- 3 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dimensional Bony Changes Following Laser Corticotomy in Rapid Canine Retraction
- ClinicalTrials.gov ID
- NCT06702956
- Acronym / sponsor ID
- Laser / Assessment of bony changes
- Conditions
- Canine Retraction
- Keywords
- bony changes, laser, canine retraction, CBCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 25 Nov 2024 (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 patient's bone morphology during orthodontic treatment is an important consideration. Therefore, during orthodontic tooth movement (OTM), an imbalance between bone resorption and deposition will cause the tooth to move out of the alveolar envelope . Unfavorable consequences like gingival recession and the dehiscence of an alveolar bone plate may arise from the movement of the teeth beyond the boundary of the bone they are housing. This happened because the dense cortical bone didn't enlarge to maintain protection for the moving root.
On the other hand, orthodontic force creates a complex loading pattern and biological response on the periodontal ligament (PDL). there was an increase in osteoclastic activity in a compression region within the PDL. In contrast, in the other tension region, there was an increase in osteoblastic activity and mineralization of the bone matrix.
Detailed description
Orthodontic tooth movement generates complex mechanical loading patterns with corresponding complex biological responses in the periodontal tissues. This will occur only if the hard tissue around the tooth can undergo proper breakdown and build-up . The primary trigger factor responsible for orthodontic tooth movement is the strain experienced by the periodontal ligament (PDL) cells and the extracellular matrix. This strain results in alteration in the gene expression within the cells, with a production of various cytokines and chemokines, capillary vasodilatation within periodontal ligament, and migration of inflammatory cells with more cytokine production and subsequent alveolar bone remodeling in response to mechanical loading .
On application of orthodontic force, the compression region within the PDL shows increased osteoclastic activity,whereas in the tension region, there is proliferation of osteoblasts and mineralization of the extracellular matrix . In general, molecules that have been linked to tensile strains and act by stimulating osteoblast progenitor cell proliferation in the periodontal ligament, with subsequent bone formation and inhibition of bone resorption similar to orthodontic tooth movement, include transforming growth factor-beta (TGF-b), various bone morphogenic proteins (BMPs), and epidermal growth factor (EGF) . On the other hand, Interleukin-1 beta (IL-1β), interleukin-6 (IL-6), CC chemokines ligand 2 (CCL2), and other inflammatory cytokines regulate osteoclastic activity through the activation of the nuclear factor kappa B (RANK) and the nuclear factor kappa B ligand (RANKL) .
Corticotomy for rapid tooth movement was introduced in 1959 by Köle to cut the alveolar bone and move a tooth. He practiced corticotomy and osteotomy on various malocclusion cases. Vertically, the cortical and marrow bone between the teeth were partially removed, and either a subapical horizontal cut with alveolar bone cutting at a distance of one cm. from the apex or only a cortical osteotomy excluding the marrow bone was performed .
Conventional treatment with fixed appliances likely requires an average of 1.5 to 2 years, resulting in a canine retraction rate of 0.5 to 1mm per month. Therefore, other modalities have been used to accelerate OTM such as pulsed electromagnetic field, corticotomy, dento-alveolar distraction, periodontal ligament distraction, and laser therapy Laser-based technology was a dream for oral surgery to find a new tool for bone cutting. Using of pulsed erbium-doped yttrium aluminium garnet (Er:YAG) lasers showed effective cutting tool with minimum degree of carbonization. Also, it can effectively accelerate canine retraction with no complications or discomfort for the patients. The Erbium laser affects the cortical bone, leading to RAP without postsurgical complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| control conventional method | Active comparator | Procedure: Conventional tooth movementconventional method of canine retraction using brackets |
| study laser corticotomy | Active comparator | Procedure: laser corticotomyan accelerated orthodontic movement using Waterlase MDTM Turbo all-tissue laser for corticotomy |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients who need extraction of maxillary first premolar in orthodontic treatment and patients who need canine retraction
Key exclusion criteria (1 listed)
- medically compromised patient
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 |
|---|---|---|
| laser corticotomystimulation of tooth movement during orthodontics treatment using Waterlase MDTM Turbo all-tissue laser therapy | Procedure or surgery | study laser corticotomy |
| Conventional tooth movementtooth movement us done using wires and brackets | Procedure or surgery | control conventional method |
Primary outcome
assessment of labial bone thickness
Time frame: 6 months
assessment of labial bone using CBCT
1 secondary outcome
assessment of root length
Time frame: 6 months
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 25 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Canine Retraction
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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
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Enrolling by invitation
Evaluation of Corticotomy-Assisted Canine Retraction Rate
Malocclusion, Corticotomy
Recruiting
Accelerated Orthodontics With Alveolar Decortication Plus CGF Injection
Accelerate Tooth Movement
Enrolling by invitation
Comparison of Maxillary Canine Retraction Rate With and Without Power Arm
Orthodontic Anchorage, Power Arm Sliding
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.
Zainab H Abdel Rahman, Phd principal investigator
lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser corticotomy and Conventional tooth movement in people with Canine Retraction, run by Ain Shams 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 1 inclusion and 1 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 25 Nov 2024. 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?
assessment of labial bone thickness (time frame: 6 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 25 Nov 2024.