Clinical trial NCT03782766: Mandibular Second Molar Protraction Assisted by Piezocision
Official title: Mandibular Second Molar Protraction Assisted by and Piezocision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acceleration of Tooth Movement
Piezocision
Keywords: Piezocision
Temporary anchorage device
molar protraction
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three models:-

* Split mouth design where piezocision will be performed on the right of left side of the patient in bilateral first molar extraction space subjects.
* comparison between 2 groups of subjects; one group where protraction is done with piezocision and the other group where protraction was done with no piezocision.
* third part where the same side of space receives the 2 interventions. Molar protraction started with no piezocision for 3 months followed by piezocision and protraction for another 3 months,
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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of second molar protraction
timeFrame: up to 3 months
measure: Changes in the level of of Interleukin1-β
timeFrame: Immediately before protraction/piezocision, 1 day, 1 week and 4 weeks after protraction/piezocision
Secondary outcomes:
measure: Anchorage loss
timeFrame: Each month up to 3 months
measure: Pain Perception: Visual analogue scale (VAS)
timeFrame: Every day up to 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Prof.- Main thesis supervisor
name: Elham S A Alhaija
role: PRINCIPAL_INVESTIGATOR
References: