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Vertical Gingival Display Changes Associated With Upper Premolars Extraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04375540
Recruitment Status : Completed
First Posted : May 5, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Elham Abu Alhaija, Jordan University of Science and Technology

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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).
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 : September 1, 2016
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

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).



Primary Outcome Measures :
  1. 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. 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.

  3. Upper anterior teeth retraction [ Time Frame: 2 years ]
    The amount of upper anterior teeth edges' retraction on cephalometric superimposition in mm

  4. Upper incisors extrusion [ Time Frame: 2 years ]
    The amount of upper incisors edges vertical displacement on cephalometric superimposition in mm


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   17 Years to 28 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04375540


Locations
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Jordan
Faculty of Dentistry/ Jordan university of Science and Technology Dental Teaching cliniucs
Irbid, Jordan
Sponsors and Collaborators
Jordan University of Science and Technology
Investigators
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Principal Investigator: Elham Abu Alhaija, PhD Jordan University of Science and Technology
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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    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elham Abu Alhaija, Jordan University of Science and Technology:
Gingival display
Tooth extraction
Dental esthetics
Corrective orthodontics