Mandibular Second Molar Protraction Assisted by Piezocision

Acceleration of Tooth Movement Clinical Trial

Official title:

Mandibular Second Molar Protraction Assisted by and Piezocision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782766
• Other study ID #: 416/2016
• Status: Completed
• Phase: N/A
• Start date: September 2, 2015
• Est. completion date: October 4, 2018

Study information

• Verified date: December 2018
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 4, 2018
• Est. primary completion date: October 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 27 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acceleration of Tooth Movement
• Piezocision

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of second molar protraction	measured in mm/month from onscreen dental cast	up to 3 months
Primary	Changes in the level of of Interleukin1-ß	detected in Gingival crevicular fluid (GCF)	Immediately before protraction/piezocision, 1 day, 1 week and 4 weeks after protraction/piezocision
Secondary	Anchorage loss	Distal movement of second premolar in mm per month	Each month up to 3 months
Secondary	Pain Perception: Visual analogue scale (VAS)	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.	Every day up to 7 days