NCT03764189

Brief Summary

accelerated anterior teeth retraction with the help of microosteoperforation procedure and miniscrews.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

1.8 years

First QC Date

December 1, 2018

Last Update Submit

December 5, 2018

Conditions

Keywords

Accelerated tooth movement AND anterior segment retraction AND miniscrews AND microosteoperforation

Outcome Measures

Primary Outcomes (1)

  • Rate of En-masse retraction

    retracting six anterior teeth

    three to six months

Secondary Outcomes (3)

  • Root resorption affecting the six anterior teeth.

    three to six months

  • Tipping affecting the anterior teeth.

    three to six months

  • Extrusion of anterior teeth

    three to six months

Study Arms (2)

en masse retraction only

NO INTERVENTION

anterior segment retraction on miniscrews without microosteoperforation

en masse retraction with alveocentesis

ACTIVE COMPARATOR

anterior segment retraction on miniscrews with microosteoperforation

Procedure: microosteoperforation

Interventions

small holes made using large round bur

Also known as: accelerated tooth movement, alveocentesis
en masse retraction with alveocentesis

Eligibility Criteria

Age16 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Females with an age ranging between 16-30 years.
  • Malocclusion that requires bilateral extraction of the maxillary first premolars and anterior segment retraction; Angle class I mal-occlusion with bi-alveolar dental protrusions or class II division 1.
  • Healthy dental and periodontal condition with a good oral hygiene
  • Absence of degenerative conditions.
  • Full set of permanent dentition.

You may not qualify if:

  • Medically compromised patients.
  • Previous orthodontic treatment
  • Patients suffering from any congenital, hereditary or systemic diseases or asymmetries that might have an influence on tooth movement
  • Chronic use of any medications affecting orthodontic tooth movement (eg: NSAIDs).
  • Active periodontal affection or severe gingival inflammation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 12566, Egypt

Location

Related Publications (10)

  • McGorray SP, Dolce C, Kramer S, Stewart D, Wheeler TT. A randomized, placebo-controlled clinical trial on the effects of recombinant human relaxin on tooth movement and short-term stability. Am J Orthod Dentofacial Orthop. 2012 Feb;141(2):196-203. doi: 10.1016/j.ajodo.2011.07.024.

    PMID: 22284287BACKGROUND
  • Nicozisis, J., Accelerated Orthodontics With Alveocentesis. Princeton Orthodontics. Clin Orthod, 2012. 19: p. 1-4

    BACKGROUND
  • Collins MK, Sinclair PM. The local use of vitamin D to increase the rate of orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 1988 Oct;94(4):278-84. doi: 10.1016/0889-5406(88)90052-2.

    PMID: 3177281BACKGROUND
  • Blanco, J., et al., Efecto de la administración sistémica del 1, 25 Dihidrxicolecalciferol sobre la velocidad del movimiento ortodóncico en humanos. Estudio Clínico. Revista Odontos, 2001. 8: p. 13-21

    BACKGROUND
  • Cruz DR, Kohara EK, Ribeiro MS, Wetter NU. Effects of low-intensity laser therapy on the orthodontic movement velocity of human teeth: a preliminary study. Lasers Surg Med. 2004;35(2):117-20. doi: 10.1002/lsm.20076.

    PMID: 15334614BACKGROUND
  • Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial. Head Face Med. 2018 Feb 17;14(1):4. doi: 10.1186/s13005-018-0161-9.

    PMID: 29454369BACKGROUND
  • Alikhani, M., et al. Micro-osteoperforations: minimally invasive accelerated tooth movement. in Seminars in Orthodontics. 2015. Elsevier

    BACKGROUND
  • Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.

    PMID: 24182579BACKGROUND
  • Ribeiro GL, Jacob HB. Understanding the basis of space closure in Orthodontics for a more efficient orthodontic treatment. Dental Press J Orthod. 2016 Mar-Apr;21(2):115-25. doi: 10.1590/2177-6709.21.2.115-125.sar.

    PMID: 27275623BACKGROUND
  • Kau CH, Kantarci A, Shaughnessy T, Vachiramon A, Santiwong P, de la Fuente A, Skrenes D, Ma D, Brawn P. Photobiomodulation accelerates orthodontic alignment in the early phase of treatment. Prog Orthod. 2013 Sep 19;14:30. doi: 10.1186/2196-1042-14-30.

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Mohamed A Kaddah, Phd

    Cairo u

    STUDY DIRECTOR

Central Study Contacts

Nashwa abdel m mohamed, master

CONTACT

Eman m el sayed, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
not possible as the subject will sign an informed consent and areas of microosteoperforation will be apparent
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 1, 2018

First Posted

December 5, 2018

Study Start

January 1, 2019

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

December 7, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

All patients' personal data of the patient will be kept safely and no patient data will be used outside the trial unless approved by the patient.

Locations