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Completed

NCT Number: NCT03782766

Mandibular Second Molar Protraction Assisted by Piezocision

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).

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Key information

Age range

20 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

Mandibular Second Molar Protraction Assisted by and Piezocision

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2018
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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