Mandibular Second Molar Protraction Assisted by Piezocision

NCT03782766 | Completed

• 1 other identifier: 416/2016
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was conducted to compare the rate of second molar protraction, level of Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque index, and periodontal pocket depth) and perception of pain in patients treated by molar protraction with piezocision vs control (no piezocision).

Conditions

Acceleration of Tooth Movement; Piezocision

Keywords

Piezocision; Temporary anchorage device; molar protraction

Outcome Measures

Primary Outcomes (2)

• Rate of second molar protraction

  measured in mm/month from onscreen dental cast

  up to 3 months

• Changes in the level of of Interleukin1-β

  detected in Gingival crevicular fluid (GCF)

  Immediately before protraction/piezocision, 1 day, 1 week and 4 weeks after protraction/piezocision

Secondary Outcomes (2)

• Anchorage loss

  Each month up to 3 months

• Pain Perception: Visual analogue scale (VAS)

  Every day up to 7 days

Study Arms (3)

piezosurgery

EXPERIMENTAL

group 1 consisted of 18 molars (13 molars from patients with bilateral first molar extraction space and 5 molars from patients with unilateral first molar extraction space) where piezocesion was performed immediately before molar protraction

Procedure: Piezocision

No piezocision

NO INTERVENTION

group 2 consisted of 21 molars (13 from patients with bilateral first molar extraction space and 8 molars from patients with unilateral first molar extraction space) where molar protraction was performed with no piezocesion

Late piezocision

OTHER

group 3 consisted of 21 molars (group 2 subjects where piezocession was carried on after 3 months of molar protraction with no piezocesion.

Procedure: Piezocision

Interventions

Piezocision PROCEDURE

Piezocesion was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm.

Late piezocision; piezosurgery

Eligibility Criteria

• Age: 20 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age range from 20 to 27 years
• at least one extracted mandibular first molar (first molar extracted more than one year ago and residual extraction space more than 5 mm)
• Class 1 malocclusion where molar protraction is indicated
• all permanent teeth are present except for the extracted mandibular first molar/molars.

You may not qualify if:

• Ggingival index score \> 2
• Plaque index score \> 2
• Probing depth \> 4mm
• Previous orthodontic treatment
• Systemic disease and
• Smoker.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Officials

• Elham S A Alhaija

  Prof.- Main thesis supervisor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Main thesis supervisor

Model Details: Three models:- * Split mouth design where piezocision will be performed on the right of left side of the patient in bilateral first molar extraction space subjects. * comparison between 2 groups of subjects; one group where protraction is done with piezocision and the other group where protraction was done with no piezocision. * third part where the same side of space receives the 2 interventions. Molar protraction started with no piezocision for 3 months followed by piezocision and protraction for another 3 months,

Study Record Dates

• First Submitted: December 15, 2018
• First Posted: December 20, 2018
• Study Start: September 2, 2015
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12