Vertical Gingival Display Changes Associated With Upper Premolars Extraction

Sponsor

Jordan University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT04375540

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gummy Smile Orthodontic Treatment	Procedure: Upper first premolars extractions Procedure: Upper second premolars extraction	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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).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).

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.	Procedure: Upper first premolars extractions 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.	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.
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).

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.

Procedure: Upper first premolars extractions

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.

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.

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).

Outcome Measures

Primary Outcome Measures

The amount of pre- and post-treatment vertical gingival display in static and dynamic positions. [2 years]
Measured from the lower edge of the upper lip to the gingival margins of the incisors in mm.
Pre- and post treatment Nose-U-lip-length [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.
Upper anterior teeth retraction [2 years]
The amount of upper anterior teeth edges' retraction on cephalometric superimposition in mm
Upper incisors extrusion [2 years]
The amount of upper incisors edges vertical displacement on cephalometric superimposition in mm

Secondary Outcome Measures

Upper molars protraction [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 28 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry/ Jordan university of Science and Technology Dental Teaching cliniucs	Irbid		Jordan

Sponsors and Collaborators

Jordan University of Science and Technology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elham Abu Alhaija, Professor, Jordan University of Science and Technology

ClinicalTrials.gov Identifier:

NCT04375540

Other Study ID Numbers:

285/2016

First Posted:

May 5, 2020

Last Update Posted:

May 7, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elham Abu Alhaija, Professor, Jordan University of Science and Technology

Gingival display

Tooth extraction

Dental esthetics

Corrective orthodontics

Study Results

No Results Posted as of May 7, 2020