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Mandibular Second Molar Protraction Assisted by Piezocision

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ClinicalTrials.gov Identifier: NCT03782766
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Elham Abu Alhaija, Jordan University of Science and Technology

Study Description
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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).

Condition or disease Intervention/treatment Phase
Acceleration of Tooth Movement Piezocision Procedure: Piezocision Not Applicable

Detailed Description:

Twenty-six subjects (39 Molars) who presented with at least one extracted mandibular first molar were selected to participate in the study. The subjects were subdivided into one of 3 groups as follows: 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 piezocision was performed immediately before molar protraction; 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 piezocision; group 3 consisted of 21 molars (group 2 subjects where piezocision was carried on after 3 months of molar protraction with no piezocision. After reaching 0.019X0.025" SS arch wire, NiTi coil spring was used for space closure (protraction force was 150g) attached from the lower second molar hook to the head of the mini-screw. Piezocision 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.

Gingival crevicular fluid (GCF) sample was obtained from the mesiogingival side of the lower second permanent molar with use of Periopaper. GCF sample was repeated 1 day, 1 week and 4 weeks after molar protraction with piezocision or with no piezocision. Pain was assessed using visual analog scale (VAS). Patients were requested to report the level of pain for 7 consecutive days.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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,
Primary Purpose: Treatment
Official Title: Mandibular Second Molar Protraction Assisted by and Piezocision
Actual Study Start Date : September 2, 2015
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : October 4, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: piezosurgery
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
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.
No Intervention: No piezocision
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
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of second molar protraction [ Time Frame: up to 3 months ]
    measured in mm/month from onscreen dental cast

  2. Changes in the level of of Interleukin1-β [ Time Frame: Immediately before protraction/piezocision, 1 day, 1 week and 4 weeks after protraction/piezocision ]
    detected in Gingival crevicular fluid (GCF)


Secondary Outcome Measures :
  1. Anchorage loss [ Time Frame: Each month up to 3 months ]
    Distal movement of second premolar in mm per month

  2. Pain Perception: Visual analogue scale (VAS) [ Time Frame: Every day up to 7 days ]
    Assessed using visual analog scale (VAS) where 0 = no pain and 10 = worst pain. The participants filled out questionnaire to assess the pain intensity and interference after second molar protraction with or without piezocision on 1, 2, 3, 4, 5, 6 and 7 days of intervention.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 27 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:-

  • Ggingival index score > 2
  • Plaque index score > 2
  • Probing depth > 4mm
  • Previous orthodontic treatment
  • Systemic disease and
  • Smoker.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782766


Sponsors and Collaborators
Jordan University of Science and Technology
Investigators
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Principal Investigator: Elham S A Alhaija Prof.- Main thesis supervisor
More Information
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Responsible Party: Elham Abu Alhaija, Principal Investigator - Main thesis supervisor, Jordan University of Science and Technology
ClinicalTrials.gov Identifier: NCT03782766    
Other Study ID Numbers: 416/2016
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elham Abu Alhaija, Jordan University of Science and Technology:
Piezocision
Temporary anchorage device
molar protraction