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Completed

NCT Number: NCT04375540

Vertical Gingival Display Changes Associated With Upper Premolars Extraction

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

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Key information

Conditions

Gummy Smile Orthodontic Treatment

Age range

17 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Irbid, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 second premolars extraction

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 5, 2020
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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