Vertical Gingival Display Changes Associated With Upper Premolars Extraction

Orthodontic Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375540
• Other study ID #: 285/2016
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: May 2020
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 28 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gummy Smile
• Orthodontic Treatment

Intervention

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

Locations

Country	Name	City	State
Jordan	Faculty of Dentistry/ Jordan university of Science and Technology Dental Teaching cliniucs	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of pre- and post-treatment vertical gingival display in static and dynamic positions.	Measured from the lower edge of the upper lip to the gingival margins of the incisors in mm.	2 years
Primary	Pre- and post treatment Nose-U-lip-length	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
Primary	Upper anterior teeth retraction	The amount of upper anterior teeth edges' retraction on cephalometric superimposition in mm	2 years
Primary	Upper incisors extrusion	The amount of upper incisors edges vertical displacement on cephalometric superimposition in mm	2 years
Secondary	Upper molars protraction	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