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

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
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
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.

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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