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Effects of Flapless Laser Corticotomy in Canine Retraction

Primary Purpose

Dental Malocclusion, Bimaxillary Protrusion

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Flapless laser corticotomy
Canine retraction
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Malocclusion focused on measuring Flapless laser corticotomy, Canine retraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthodontic department , Faculty of dentistry , Suez Canal University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Maxillary flapless laser corticotomy group

Maxillary control group

Mandibular flapless laser corticotomy group

Mandibular control group

Arm Description

Flapless laser corticotomy will randomly be assigned to one side of the 14 maxillary arches (experimental side) before canine retraction.

Canine retraction will be done on the other side without Laser corticotomy .

Flapless laser corticotomy will randomly be assigned to one side of the 14 mandibular arches (experimental side) before canine retraction.

Canine retraction will be done on the other side without Laser corticotomy .

Outcomes

Primary Outcome Measures

Rate of canine retraction.
distal movement of the canine , measurement unit mm divided by time unit month , using scanned digital models

Secondary Outcome Measures

Canine rotation
rotation of canine measured in degrees , after 3 months of canine retraction using scanned digital models
First molar anchorage loss
mesial movement of first molar measured in mm , after 3 months of canine retraction using scanned digital models
Root resorption
canine root length measured in mm using cone beam CT scans
Periodontal condition
assessed using periodontal probe to measure : probing depth in mm
Pulp vitality
assessed using thermal (Cold ) test , by application of dry cotton sprayed with ethyl chloride

Full Information

First Posted
October 30, 2020
Last Updated
October 30, 2022
Sponsor
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT04631419
Brief Title
Effects of Flapless Laser Corticotomy in Canine Retraction
Official Title
Effects of Flapless Laser Corticotomy in Canine Retraction: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is conducted to evaluate the effects of flapless laser corticotomy on the rate of canine retraction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Malocclusion, Bimaxillary Protrusion
Keywords
Flapless laser corticotomy, Canine retraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
single-blind
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maxillary flapless laser corticotomy group
Arm Type
Experimental
Arm Description
Flapless laser corticotomy will randomly be assigned to one side of the 14 maxillary arches (experimental side) before canine retraction.
Arm Title
Maxillary control group
Arm Type
Active Comparator
Arm Description
Canine retraction will be done on the other side without Laser corticotomy .
Arm Title
Mandibular flapless laser corticotomy group
Arm Type
Experimental
Arm Description
Flapless laser corticotomy will randomly be assigned to one side of the 14 mandibular arches (experimental side) before canine retraction.
Arm Title
Mandibular control group
Arm Type
Active Comparator
Arm Description
Canine retraction will be done on the other side without Laser corticotomy .
Intervention Type
Other
Intervention Name(s)
Flapless laser corticotomy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Canine retraction
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of canine retraction.
Description
distal movement of the canine , measurement unit mm divided by time unit month , using scanned digital models
Time Frame
3 months of canine retraction , distance (mm) moved by the canine distally per month
Secondary Outcome Measure Information:
Title
Canine rotation
Description
rotation of canine measured in degrees , after 3 months of canine retraction using scanned digital models
Time Frame
3 months, assessed at the beginning of treatment (base line ), and at the end of 3 months of canine retraction
Title
First molar anchorage loss
Description
mesial movement of first molar measured in mm , after 3 months of canine retraction using scanned digital models
Time Frame
3 months, assessed immediately before canine retraction and at the end of 3 months of canine retraction
Title
Root resorption
Description
canine root length measured in mm using cone beam CT scans
Time Frame
3 months , assessed at the beginning of treatment (base line ), and at the end of 3 months of canine retraction
Title
Periodontal condition
Description
assessed using periodontal probe to measure : probing depth in mm
Time Frame
3 months , immediately before canine retraction , and at the end of 3 months of canine retraction
Title
Pulp vitality
Description
assessed using thermal (Cold ) test , by application of dry cotton sprayed with ethyl chloride
Time Frame
3 months, assessed immediately before canine retraction , and at the end of 3 months of canine retraction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abubakr R Bakr, Msc Assistan lecturer
Organizational Affiliation
Faculty of dentistry , Suez canal university , Ismailia , Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthodontic department , Faculty of dentistry , Suez Canal University
City
Ismailia
Country
Egypt

12. IPD Sharing Statement

Links:
URL
http://jbcd.uobaghdad.edu.iq/index.php/jbcd/article/view/530
Description
Acceleration of canine movement by laser assisted flapless corticotomy [An innovative approach in clinical orthodontics
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5816528/
Description
Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial

Learn more about this trial

Effects of Flapless Laser Corticotomy in Canine Retraction

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