NCT04631419

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

2.5 years

First QC Date

October 30, 2020

Last Update Submit

October 30, 2022

Conditions

Keywords

Flapless laser corticotomyCanine retraction

Outcome Measures

Primary Outcomes (1)

  • Rate of canine retraction.

    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 Outcomes (5)

  • Canine rotation

    3 months, assessed at the beginning of treatment (base line ), and at the end of 3 months of canine retraction

  • First molar anchorage loss

    3 months, assessed immediately before canine retraction and at the end of 3 months of canine retraction

  • Root resorption

    3 months , assessed at the beginning of treatment (base line ), and at the end of 3 months of canine retraction

  • Periodontal condition

    3 months , immediately before canine retraction , and at the end of 3 months of canine retraction

  • Pulp vitality

    3 months, assessed immediately before canine retraction , and at the end of 3 months of canine retraction

Study Arms (4)

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.

Other: Flapless laser corticotomyOther: Canine retraction

Maxillary control group

ACTIVE COMPARATOR

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

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.

Other: Flapless laser corticotomyOther: Canine retraction

Mandibular control group

ACTIVE COMPARATOR

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

Other: Canine retraction

Interventions

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.

Mandibular flapless laser corticotomy groupMaxillary flapless laser corticotomy group

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

Mandibular control groupMandibular flapless laser corticotomy groupMaxillary control groupMaxillary flapless laser corticotomy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthodontic department , Faculty of dentistry , Suez Canal University

Ismailia, Egypt

Location

Related Links

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Abubakr R Bakr, Msc Assistan lecturer

    Faculty of dentistry , Suez canal university , Ismailia , Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
single-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer , PhD student

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 17, 2020

Study Start

June 1, 2018

Primary Completion

December 1, 2020

Study Completion

December 30, 2020

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations