Vertical Gingival Display Changes Associated With Upper Premolars Extraction

NCT ID: NCT04375540

Last Updated: 2020-05-07

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

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-12-01

Brief Summary

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To investigate and compare vertical gingival display (VGD) changes associated with upper premolars extraction during orthodontic treatment.

Detailed Description

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Seventy-six subjects who met the inclusion criteria were divided into one of 3 groups according to their treatment modalities as follows: group 1: upper first premolars extraction (24 patients, aged 21.56±3.19 years); group 2: upper second premolars extraction (26 patients, aged 22.16±3.59 years) and group 3: no orthodontic intervention was performed (happy with their teeth) (26 subjects, aged 20.45±3.29 years).

Initial records (radiographs, study casts and clinical photographs) were taken for all subjects. The same records were taken post treatment for treated subjects only. The Pre- and post- treatment VGD and lip length in static and dynamic positions and the amount of upper teeth retractions were recorded.

The paired t-test and ANOVA test were used to detect treatment changes and differences between studied groups, respectively. Factors affecting VGD were investigated using backward stepwise linear regression analysis.

Conditions

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Gummy Smile Orthodontic Treatment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Group 1: upper first premolars extraction (24 patients) Group 2: upper second premolars extraction (26 patients) and Group 3: no orthodontic intervention was performed (happy with their teeth) (26 subjects).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Study casts and cephalometric analysis were performed by different person (D. T.) who did not know to which group the patient belongs. Records were given numbers.

Study Groups

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Upper first premolars extraction

Included 24 patients (7 males,17 females) with a mean age of 21.56±3.19years who were treated with fixed orthodontic appliance for 2.22±0.31years.

Group Type EXPERIMENTAL

Upper first premolars extractions

Intervention Type PROCEDURE

Fixed orthodontic treatment with upper first premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain.

Upper second premolars extraction

Included 26 patients (8 males,18 females) with a mean age of 22.16±3.59years who were treated with fixed orthodontic appliance for 2.25±0.30 years.

Group Type EXPERIMENTAL

Upper second premolars extraction

Intervention Type PROCEDURE

Fixed orthodontic treatment with upper second premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain.

No intervention

Included 26 subjects (10 males, 16 females) with a mean age of 20.45±3.29years.This group was included to observe any changes in the vertical gingival display over the 2 years' observation period (1.65±0.17 years).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Upper first premolars extractions

Fixed orthodontic treatment with upper first premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain.

Intervention Type PROCEDURE

Upper second premolars extraction

Fixed orthodontic treatment with upper second premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age 17 years or more
* skeletal class I or class II malocclusion
* upper premolars extraction treatment plan
* high smile line 2mm or more
* no previous orthodontic treatment.

Exclusion Criteria

* poor oral hygiene
* lower arch extraction treatment plan
* smoking
* Any systemic or periodiontal disease.
Minimum Eligible Age

17 Years

Maximum Eligible Age

28 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 Abu Alhaija, PhD

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

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Faculty of Dentistry/ Jordan university of Science and Technology Dental Teaching cliniucs

Irbid, , Jordan

Site Status

Countries

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Jordan

Other Identifiers

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285/2016

Identifier Type: -

Identifier Source: org_study_id

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