Clinical trial NCT04338789: Accelerated Mandibular Molar Protraction: Piezocision at the Time of Molar Protraction or Later?
Official title: Mandibular Molar Protraction Assisted by Temporary Anchorage Device and Piezoelectric Corticotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance
Keywords: Piezocision
molar protraction
Accelerated
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of molar protraction
timeFrame: 1 year
measure: Changes in the level of of Interleukin1-β
timeFrame: 4 weeks
Secondary outcomes:
measure: Periodontal parameters (Plaque, gingival health, periodontal pocket depth, alveolar bone height)
timeFrame: 1 year
measure: Lower molar root resorption
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Prof.
name: Elham S A Alhaija, PhD
role: PRINCIPAL_INVESTIGATOR
References: