- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04631419
Effects of Flapless Laser Corticotomy in Canine Retraction
October 30, 2022 updated by: Abubakr Reda Fadeel Ali Bakr, Suez Canal University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ismailia, Egypt
- Orthodontic department , Faculty of dentistry , Suez Canal University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Maxillary flapless laser corticotomy group
Flapless laser corticotomy will randomly be assigned to one side of the 14 maxillary arches (experimental side) before canine retraction.
|
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 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
|
|
ACTIVE_COMPARATOR: Maxillary control group
Canine retraction will be done on the other side without Laser corticotomy .
|
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
|
|
EXPERIMENTAL: Mandibular flapless laser corticotomy group
Flapless laser corticotomy will randomly be assigned to one side of the 14 mandibular arches (experimental side) before canine retraction.
|
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 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
|
|
ACTIVE_COMPARATOR: Mandibular control group
Canine retraction will be done on the other side without Laser corticotomy .
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 months of canine retraction , distance (mm) moved by the canine distally per month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Canine rotation
Time Frame: 3 months, assessed at the beginning of treatment (base line ), and at the end of 3 months of canine retraction
|
rotation of canine measured in degrees , after 3 months of canine retraction using scanned digital models
|
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
|
mesial movement of first molar measured in mm , after 3 months of canine retraction using scanned digital models
|
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
|
canine root length measured in mm using cone beam CT scans
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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
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assessed using periodontal probe to measure : probing depth in mm
|
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
|
assessed using thermal (Cold ) test , by application of dry cotton sprayed with ethyl chloride
|
3 months, assessed immediately before canine retraction , and at the end of 3 months of canine retraction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abubakr R Bakr, Msc Assistan lecturer, Faculty of dentistry , Suez canal university , Ismailia , Egypt
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2018
Primary Completion (ACTUAL)
December 1, 2020
Study Completion (ACTUAL)
December 30, 2020
Study Registration Dates
First Submitted
October 30, 2020
First Submitted That Met QC Criteria
November 10, 2020
First Posted (ACTUAL)
November 17, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 1, 2022
Last Update Submitted That Met QC Criteria
October 30, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Flapless Laser Corticotomy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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