Vertical Gingival Display Changes Associated With Upper Premolars Extraction

May 5, 2020 updated by: Elham Abu Alhaija, Jordan University of Science and Technology

Vertical Gingival Display Changes Associated With Upper Premolars Extraction Orthodontic Treatment in Gummy Smile Patients: A Prospective Clinical Trial

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

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Fixed orthodontic treatment with upper first premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain.
Experimental: 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.
Fixed orthodontic treatment with upper second premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The amount of pre- and post-treatment vertical gingival display in static and dynamic positions.
Time Frame: 2 years
Measured from the lower edge of the upper lip to the gingival margins of the incisors in mm.
2 years
Pre- and post treatment Nose-U-lip-length
Time Frame: 2 years
Measured from the soft tissue subnasale to the upper lip stomion (base of the nose to the lip edge of the upper lip) in mm.
2 years
Upper anterior teeth retraction
Time Frame: 2 years
The amount of upper anterior teeth edges' retraction on cephalometric superimposition in mm
2 years
Upper incisors extrusion
Time Frame: 2 years
The amount of upper incisors edges vertical displacement on cephalometric superimposition in mm
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper molars protraction
Time Frame: 2 years
The amount of upper molars protraction measured from the mesial contact point of the molar in the baseline model to the mesial contact point of the transposed transparent model(S1) in mm
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elham Abu Alhaija, PhD, Jordan University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 2, 2020

First Submitted That Met QC Criteria

May 2, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

May 7, 2020

Last Update Submitted That Met QC Criteria

May 5, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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