NCT03180151

Brief Summary

  • To compare patients who will undergo orthodontics treatment involving upper premolar extraction for space of time whether with or without corticotomy by Piezotome.
  • Assess the safety of both methods of retraction in regard to the quality of the surrounding periodontium and roots of anterior teeth.
  • Monitor postoperative pain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

December 25, 2016

Last Update Submit

October 2, 2023

Conditions

Keywords

corticotomyenmass retractionmini implant

Outcome Measures

Primary Outcomes (1)

  • rate of tooth movement per time

    4 months

Study Arms (2)

Orthodontic tooth movement group

NO INTERVENTION

This is the control group in which pateints will be treated by conventional orthodontic treatment and extraction of premolars without piezotome

Corticotomy assisted orthodontic group

EXPERIMENTAL

This is the study group in which patients will be treated by conventional orthodontic treatment aided by corticotomy procedure perfumed by using a piezotome.(piezotome assisted orthodontic tooth movement)

Procedure: piezotome assisted orthodontic tooth movement

Interventions

Surgical procedure 1. After local anesthesia, vertical interproximal incisions will be done under the interdental papilla, on the labial aspect of upper arch using a blade No. 15. 2. The incisions will be kept minimal. 3. The incisions go though the periosteum, which permit the blade to reach to the alveolar bone. 4. A Piezo surgical knife will be used to make the cortical alveolar incision through the gingival incisions to a depth of approximately 3mm. 5. As we will not use bone graft so we don't need use suturing after cortication. 6. We give patient antibiotic and analgesic cover.

Also known as: corticotomy assisted tooth movement
Corticotomy assisted orthodontic group

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • On the basis of the diagnosis of the malocclusion, individuals who have Class I and Class II malocclusions and requiring extraction of premolars and retraction of anterior teeth will be selected (maxillary/mandibular or both).
  • Good oral hygiene, healthy gingiva and no evidence of bone loss as seen in radiograph.
  • Healthy systemic conditions.
  • No previous orthodontic treatment.
  • Patient needs to be in permanent dentition (hence, we need to define their age range).

You may not qualify if:

  • Patient with systemic disease.
  • Patient having any signs of active periodontal disease.
  • Patients on long-term corticosteroid therapy.
  • Persons taking medications that slows down bone metabolism.
  • Craniofacial anomalies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hatrom AA, Howait MS, Zawawi KH, Al-Turki GA, Alansari RA, Almehayawi NF, Alammari SH, Mohammed RA, Hassan AH. Pulp volume changes after piezocision-assisted tooth movement: a randomized clinical trial. BMC Oral Health. 2021 Jan 13;21(1):28. doi: 10.1186/s12903-020-01382-2.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in orthodontic department

Study Record Dates

First Submitted

December 25, 2016

First Posted

June 8, 2017

Study Start

September 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

October 3, 2023

Record last verified: 2023-10