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

NCT04338789 | Completed

• 1 other identifier: 266/216
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 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).

Conditions

Orthodontic Appliance

Keywords

Piezocision; molar protraction; Accelerated

Outcome Measures

Primary Outcomes (2)

• Rate of molar protraction

  Measured in mm/month from dental casts

  1 year

• Changes in the level of of Interleukin1-β

  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 Outcomes (2)

• Periodontal parameters (Plaque, gingival health, periodontal pocket depth, alveolar bone height)

  1 year

• Lower molar root resorption

  1 year

Study Arms (3)

Group 1

EXPERIMENTAL

It consisted of 20 subjects with bilateral first molar extraction space where piezocesion was performed immediately before molar protraction on the left or right side of the patient.

Other: Piezocision

Group 2

EXPERIMENTAL

It consisted of 20 subjects with bilateral first molar extraction space where piezocesion was performed 3 months after molar protraction with no piezocision on the left or right side of the patient.

Other: Piezocision

Group 3

NO INTERVENTION

It consisted of 20 subjects (40 molars) where molar protraction was performed with no piezocesion.

Interventions

Piezocision OTHER

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.

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Previous orthodontic treatment
• Any systemic disease
• Smoker
• Poor Oral hygiene

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Officials

• Elham S A Alhaija, PhD

  Prof.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of either patient or clinician was not possible during treatment. However, partial blinding was possible. Orthodontic molar protraction was carried out by the clinician without knowing the GCF levels and the lab was blinded to the clinical findings. Also, periapical radiographs and study casts were masks during data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Split mouth design where piezocision will be performed at the time of molar protraction on the right or left side of the bilateral first molar extraction subjects and 3 months of molar protraction on the other side. A third group of subjects will act as a control where molar protraction will be done with no piezocision. \- Comparison between the 3 groups of subjects; Early piezocision, late piezocision and no piezocision molar protraction groups.

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: April 8, 2020
• Study Start: December 2, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 8, 2020

Record last verified: 2020-04