NCT03535285

Brief Summary

Surgical modification technique try to get bodily movement during upper canine retraction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 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 15, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

May 10, 2018

Last Update Submit

May 23, 2018

Conditions

Keywords

periodontal ligamentdentoalveolardistractionorthodontic

Outcome Measures

Primary Outcomes (3)

  • Tipping of the canines

    1. Periapical radiograph using Parallel technique (X-ray sensor , X-ray sensor holder \& Potable dental x-ray unit 2. Panoramic radiograph .

    3-4 weeks

  • Rate of canines retraction

    Digital models using 3shape scanner and Ortho-Analyzer software

    3-4 weeks

  • Rotation of the canines

    Digital models using 3shape scanner and Ortho-Analyzer software

    3-4 weeks

Secondary Outcomes (7)

  • Amount of anchorage loss

    3-4 weeks

  • Tipping of the molars

    3-4 weeks

  • The apical root resorption scores

    3-4 weeks

  • Pulp Vitality

    3-4 weeks

  • Gingival index

    3-4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Surgical modification side

EXPERIMENTAL

Periodontal ligament distraction without the oblique cuts but with apical horizontal cut

Procedure: Periodontal ligament distraction

Conventional surgery

ACTIVE COMPARATOR

Periodontal ligament distraction

Procedure: Periodontal ligament distraction

Interventions

decrease the bony resistant during canine retration

Also known as: Acceleration of canine retraction
Conventional surgerySurgical modification side

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Orthodontic patients needed extraction of upper first premolars, with age range from 18 - 25 years old.
  • All patients were medically free. (See Appendix II)
  • No previous orthodontic treatment.
  • Adequate oral hygiene and periodontally healthy teeth.
  • The canines were almost leveled and aligned.
  • Maximum anchorage requirements.
  • Healthy canines; no deep carious lesions, no endodontic lesions, no root canal treatment, nor internal or external root resorption.
  • All patients were informed of the procedure and signed the consents.

You may not qualify if:

  • Subjects were excluded from the study when:
  • They failed to keep several consecutive appointments.
  • Oral hygiene was subjectively judged as deteriorating during the preliminary stages of patient preparation.
  • Compliance with the instructions provided was inadequate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University - Orthodontic department

Cairo, 11111, Egypt

Location

Related Publications (1)

  • Liou EJ, Huang CS. Rapid canine retraction through distraction of the periodontal ligament. Am J Orthod Dentofacial Orthop. 1998 Oct;114(4):372-82. doi: 10.1016/s0889-5406(98)70181-7.

Related Links

Study Officials

  • Monaser M Elashik, Master

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Split-mouth
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 10, 2018

First Posted

May 24, 2018

Study Start

June 15, 2017

Primary Completion

August 15, 2017

Study Completion

December 15, 2017

Last Updated

May 25, 2018

Record last verified: 2018-05

Locations