Gummy SmileNCT04375540
Vertical Gingival Display Changes Associated With Upper Premolars Extraction
A study testing Upper first premolars extractions and Upper second premolars extraction in people with Gummy Smile and Orthodontic Treatment, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
To investigate and compare vertical gingival display (VGD) changes associated with upper premolars extraction during orthodontic treatment. Read more about this study
- Who is it for?
- Ages 17 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Gummy Smile, Orthodontic Treatment
- What is being tested?
- Upper first premolars extractions and Upper second premolars extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteJordan
- Study dates
- 1 Sep 2016to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- poor oral hygiene
- lower arch extraction treatment plan
- smoking
- Any systemic or periodiontal disease.
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Faculty of Dentistry/ Jordan university of Science and Technology Dental Teaching cliniucs
Irbid
About this study
Official title: Vertical Gingival Display Changes Associated With Upper Premolars Extraction Orthodontic Treatment in Gummy Smile Patients: A Prospective Clinical Trial
To investigate and compare vertical gingival display (VGD) changes associated with upper premolars extraction during orthodontic treatment.
Read the 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.
- Conditions
- Gummy Smile, Orthodontic Treatment
- Being tested
- Upper first premolars extractions, Upper second premolars extraction
- Keywords
- Gingival display, Tooth extraction, Dental esthetics, Corrective orthodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper first premolars extractionsProcedure or surgery
Fixed orthodontic treatment with upper first premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain.
Upper second premolars extractionProcedure or surgery
Fixed orthodontic treatment with upper second premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Upper anterior teeth retraction
The amount of upper anterior teeth edges' retraction on cephalometric superimposition in mm
Measured: 2 years
Upper incisors extrusion
The amount of upper incisors edges vertical displacement on cephalometric superimposition in mm
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Sep 2016
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gummy SmileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham Abu Alhaija, Jordan University of Science and Technology
- Investigators
- Elham Abu Alhaija, PhD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375540
- Sponsor's protocol ID
- 285/2016
- Status last verified
- May 2020
- First submitted
- 2 May 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertical Gingival Display Changes Associated With Upper Premolars Extraction Orthodontic Treatment in Gummy Smile Patients: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04375540
- Acronym / sponsor ID
- 285/2016
- Conditions
- Gummy Smile, Orthodontic Treatment
- Keywords
- Gingival display, Tooth extraction, Dental esthetics, Corrective orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate and compare vertical gingival display (VGD) changes associated with upper premolars extraction during orthodontic treatment.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Upper first premolars extraction | Experimental | Procedure: Upper first premolars extractionsIncluded 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. |
| Upper second premolars extraction | Experimental | Procedure: Upper second premolars extractionIncluded 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. |
| 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). |
Who may qualify
- Ages
- 17 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- poor oral hygiene
- lower arch extraction treatment plan
- smoking
- Any systemic or periodiontal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper first premolars extractionsFixed orthodontic treatment with upper first premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain. | Procedure or surgery | Upper first premolars extraction |
| Upper second premolars extractionFixed orthodontic treatment with upper second premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain. | Procedure or surgery | Upper second premolars extraction |
Primary outcome
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.
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.
Upper anterior teeth retraction
Time frame: 2 years
The amount of upper anterior teeth edges' retraction on cephalometric superimposition in mm
Upper incisors extrusion
Time frame: 2 years
The amount of upper incisors edges vertical displacement on cephalometric superimposition in mm
1 secondary outcome
Upper molars protraction
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elham Abu Alhaija, PhD principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper first premolars extractions and Upper second premolars extraction in people with Gummy Smile and Orthodontic Treatment, run by Jordan University of Science and Technology at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of pre- and post-treatment vertical gingival display in static and dynamic positions. (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.