NCT04553952

Brief Summary

This study primarily aimed to evaluate smile line distribution and prevalence of gummy smile in patients. The secondary purpose was to examine parameters that might be risk factors for gummy smile.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

September 7, 2020

Last Update Submit

September 12, 2020

Conditions

Gummy Smile

Outcome Measures

Primary Outcomes (1)

  • Measurement of gingival display

    All individuals were instructed to sit on a dental chair and the measurments were made by using a millimetric ruler. Next, the patients were grouped according to Liebart's classification by gingival display at maximum smile as follows: Class 1.Excessive gingival display (Gummy smile): ≥ 3mm gingival display Class 2.High smile line: 0-2 mm of gingival display Class 3. Average smile line: Dental papilla is visible. Class 4. Low smile line: Gingival margin, dental papilla is not visible at all.

    1 minute

Study Arms (2)

Gummy smile (GS(+))

Other: Measurement of gingival display

Gumms smile(GS(-))

Other: Measurement of gingival display

Interventions

Measurement of gingival displayOTHER

All individuals were instructed to sit on a dental chair and the measurements were made by using a millimetric ruler. Next, the patients were grouped according to Liebart's classification by gingival display at maximum smile as follows: Class 1.Excessive gingival display (Gummy smile): ≥ 3mm gingival display Class 2.High smile line: 0-2 mm of gingival display Class 3. Average smile line: Dental papilla is visible. Class 4. Low smile line: Gingival margin, dental papilla is not visible at all.

Gumms smile(GS(-))Gummy smile (GS(+))

Eligibility Criteria

Age20 Years - 61 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who applied to Baskent University Faculty of Dentistry for seeking dental treatment

You may qualify if:

  • presence of teeth in upper jaw
  • Age between 18-65 years

You may not qualify if:

  • Patients who have received and/or are receiving orthodontic treatment and patients who received gummy smile treatment were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University,Department of Dentistry

Ankara, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS,PhD

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 18, 2020

Study Start

November 9, 2019

Primary Completion

February 24, 2020

Study Completion

March 22, 2020

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations

TU(1)