Mandibular Second Molar Protraction Assisted by Piezocision

Not Applicable

Completed

• Conditions: Acceleration of Tooth Movement; Piezocision
• Interventions: Procedure: Piezocision

• Registration Number: NCT03782766
• Lead Sponsor: Jordan University of Science and Technology

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).

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 Timeline

• Study Start: 2015-09-02
• Primary Completion: 2018-10-04
• Study Completion: 2018-10-04
• Status Verified: 2018-12
• Study First Submitted: 2018-12-15
• Study First Submitted QC: 2018-12-19
• Last Update Submitted: 2018-12-19
• Study First Posted: 2018-12-20
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
piezosurgery	Piezocision	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
Late piezocision	Piezocision	group 3 consisted of 21 molars (group 2 subjects where piezocession was carried on after 3 months of molar protraction with no piezocesion.

Primary Outcome Measures

Name	Time	Method
Rate of second molar protraction	up to 3 months	measured in mm/month from onscreen dental cast
Changes in the level of of Interleukin1-β	Immediately before protraction/piezocision, 1 day, 1 week and 4 weeks after protraction/piezocision	detected in Gingival crevicular fluid (GCF)

Secondary Outcome Measures

Name	Time	Method
Pain Perception: Visual analogue scale (VAS)	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.
Anchorage loss	Each month up to 3 months	Distal movement of second premolar in mm per month