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Mandibular Second Molar Protraction Assisted by Piezocision

NCT ID: NCT03782766

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-02

Study Completion Date

2018-10-04

Brief Summary

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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

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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.

Conditions

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Acceleration of Tooth Movement Piezocision

Keywords

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Piezocision Temporary anchorage device molar protraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Study Groups

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piezosurgery

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 piezocesion was performed immediately before molar protraction

Group Type EXPERIMENTAL

Piezocision

Intervention Type PROCEDURE

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.

No piezocision

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 piezocesion

Group Type NO_INTERVENTION

No interventions assigned to this group

Late piezocision

group 3 consisted of 21 molars (group 2 subjects where piezocession was carried on after 3 months of molar protraction with no piezocesion.

Group Type OTHER

Piezocision

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

27 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jordan University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Elham Abu Alhaija

Principal Investigator - Main thesis supervisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elham S A Alhaija

Role: PRINCIPAL_INVESTIGATOR

Prof.- Main thesis supervisor

Other Identifiers

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416/2016

Identifier Type: -

Identifier Source: org_study_id