NCT04611984

Brief Summary

The aim of this study was to evaluate the tooth movement with and without piezocision with regard to the levels of osteocalcin and cross-linked C-terminal telopeptides of type I collagen in the gingival crevicular fluid.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

October 20, 2020

Last Update Submit

October 30, 2020

Conditions

Keywords

Tooth movementPiezocisionGingival crevicular fluidOsteocalcin

Outcome Measures

Primary Outcomes (2)

  • Gingival crevicular fluid osteocalcin level (ng/ml)

    Gingival crevicular fluid samples were collected from mesial and distal sides of the maxillary right and left canines.The gingival crevicular fluid level of osteocalcin was determined by using ELISA

    28 days after canine distalization

  • Gingival crevicular fluid cross-linked C-terminal telopeptides of type I level (ng/ml)

    Gingival crevicular fluid samples were collected from mesial and distal sides of the maxillary right and left canines.The gingival crevicular fluid level of cross-linked C-terminal telopeptides of type I collagen was determined by using ELISA.

    28 days after canine distalization

Secondary Outcomes (2)

  • The amount of canine movement (mm)

    Baseline (day 0) before canine distalization and, 14 and 28 days after canine distalization

  • Retraction rate (mm/day) of canine movement

    14 and 28 days after canine distalization

Study Arms (2)

Piezocision

EXPERIMENTAL

Piezocision was performed on the mesial and distal side of the maxillary right canine tooth which was served as the piezocision group. Then canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage.

Procedure: Piezocision

Control

ACTIVE COMPARATOR

Maxillary left canine served as the control group and canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage.

Procedure: Control

Interventions

PiezocisionPROCEDURE

Piezocisions were performed on the mesial and distal sides of the right maxillary canines. Then canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage.

Piezocision
ControlPROCEDURE

The mesial and distal sides of the left maxillary canines served as controls and canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage.

Control

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Class I, Class II or Class III malocclusion,
  • Proclined incisors requiring extraction of the maxillary first premolars with subsequent retraction of the maxillary canines
  • No previous orthodontic treatment
  • Good oral hygiene and periodontal health (plaque and gingival indices less or equal 1, probing depth less or equal 3 mm, no radiographic bone loss).

You may not qualify if:

  • having systemic diseases that could affect bone and tooth movement
  • smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (3)

  • Dibart S, Surmenian J, Sebaoun JD, Montesani L. Rapid treatment of Class II malocclusion with piezocision: two case reports. Int J Periodontics Restorative Dent. 2010 Oct;30(5):487-93.

    PMID: 20814602BACKGROUND
  • Alfaqeeh SA, Anil S. Osteocalcin and N-telopeptides of type I collagen marker levels in gingival crevicular fluid during different stages of orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2011 Jun;139(6):e553-9. doi: 10.1016/j.ajodo.2011.03.005.

    PMID: 21640867BACKGROUND
  • Raj SC, Praharaj K, Barik AK, Patnaik K, Mahapatra A, Mohanty D, Katti N, Mishra D, Panda SM. Retraction With and Without Piezocision-Facilitated Orthodontics: A Randomized Controlled Trial. Int J Periodontics Restorative Dent. 2020 Jan/Feb;40(1):e19-e26. doi: 10.11607/prd.3968.

    PMID: 31815981BACKGROUND

Study Officials

  • Hatice Selin Yıldırım, Dr.

    Marmara University, Faculty of Dentistry, Department of Peridontology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigators performing the clinical and surgical procedures, and patients were not blinded. Data assessment was performed by a blinded researcher. Gingival crevicular fluid samples were collected and numbered by another blinded researcher.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2020

First Posted

November 2, 2020

Study Start

March 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations