- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04375540
Vertical Gingival Display Changes Associated With Upper Premolars Extraction
Vertical Gingival Display Changes Associated With Upper Premolars Extraction Orthodontic Treatment in Gummy Smile Patients: A Prospective Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Irbid, Jordan
- Faculty of Dentistry/ Jordan university of Science and Technology Dental Teaching cliniucs
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Elham Abu Alhaija, PhD, Jordan University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 285/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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