Vertical Gingival Display Changes Associated With Upper Premolars Extraction

NCT04375540 | Completed

• 1 other identifier: 285/2016
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gummy Smile; Orthodontic Treatment

Keywords

Gingival display; Tooth extraction; Dental esthetics; Corrective orthodontics

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Upper anterior teeth retraction

  The amount of upper anterior teeth edges' retraction on cephalometric superimposition in mm

  2 years

• Upper incisors extrusion

  The amount of upper incisors edges vertical displacement on cephalometric superimposition in mm

  2 years

Secondary Outcomes (1)

• Upper molars protraction

  2 years

Study Arms (3)

Upper first premolars extraction

EXPERIMENTAL

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

Upper second premolars extraction

EXPERIMENTAL

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

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).

Interventions

Upper first premolars extractions PROCEDURE

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

Upper first premolars extraction

Upper second premolars extraction PROCEDURE

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

Upper second premolars extraction

Eligibility Criteria

• Age: 17 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• poor oral hygiene
• lower arch extraction treatment plan
• smoking
• Any systemic or periodiontal disease.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

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

Irbid, Jordan

Location

Study Officials

• Elham Abu Alhaija, PhD

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 5, 2020
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)