Accelerated Mandibular Molar Protraction: Piezocision at the Time of Molar Protraction or Later?

Orthodontic Appliance Clinical Trial

Official title:

Mandibular Molar Protraction Assisted by Temporary Anchorage Device and Piezoelectric Corticotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04338789
• Other study ID #: 266/216
• Status: Completed
• Phase: N/A
• Start date: December 2, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• 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 root resorption in patients treated by molar protraction with piezocision performed early at the time of protraction (Group 1), piezocision performed 3 months after molar protraction (Group 2), and no piezocision molar protraction (Group 3).

Description:

Detailed Description: Thirty-five subjects who presented with bilaterally 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 20 subjects /20 molars where piezocision was performed immediately before molar protraction; group 2 consisted of 20 subjects/ 20 molars where molar protraction was carried on after 3 months of molar protraction with no piezocision; group 3 consisted of 20 subjects (40 molars) where protraction was carried out 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. Periodontal parameters were measured and lower molar root resorption was assessed using Perapical radiographs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 30 Years

Eligibility

Inclusion Criteria:

• Age range from 19 to 30 years

• Bilaterally extracted mandibular first molar (first molar extracted more than one year ago and with a residual extraction space of more than 6 mm).

• Class 1 malocclusion where molar protraction is indicated.

• All permanent teeth are present except for the extracted mandibular first molars.

• Healthy periodontium (gingival index score = 2, plaque index score = 2 and probing depth < 4mm)

Exclusion Criteria:

• Previous orthodontic treatment

• Any systemic disease

• Smoker

• Poor Oral hygiene

Related Conditions & MeSH terms

• Orthodontic Appliance

Intervention

Other:
• 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 molar protraction	Measured in mm/month from dental casts	1 year
Primary	Changes in the level of of Interleukin1-ß	Detected in Gingival crevicular fluid (GCF). The periopaper was placed for 60 seconds in the mesiogingival sulcus of the lower second permanent molar and was transferred to an Eppendorf tube containing phosphate buffered saline.	4 weeks
Secondary	Periodontal parameters (Plaque, gingival health, periodontal pocket depth, alveolar bone height)	Plaque and gingival health are measured using plaque index and gingival index. pocket depth and alveolar height are measured in mm.	1 year
Secondary	Lower molar root resorption	Length of lower second molar roots in mm	1 year