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

NCT ID: NCT04338789

Last Updated: 2020-04-08

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-02

Study Completion Date

2019-12-31

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 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

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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.

Conditions

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Orthodontic Appliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Group 1

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.

Group Type EXPERIMENTAL

Piezocision

Intervention Type 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 2

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.

Group Type EXPERIMENTAL

Piezocision

Intervention Type 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 3

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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 OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

30 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

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elham S A Alhaija, PhD

Role: PRINCIPAL_INVESTIGATOR

Prof.

Other Identifiers

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266/216

Identifier Type: -

Identifier Source: org_study_id

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