Gummy Smile Due to Hypermobile Upper LipEarly Phase 1NCT03186547
Satisfaction Of Adult Patients With Gummy Smile Treated By Botulinum Toxin A Injection
A Early Phase 1 study testing Botulinum Toxin A Injection and Modified Lip Repositioning Surgery in people with Gummy Smile Due to Hypermobile Upper Lip, run by Cairo University.
Trial summary
The aim of the proposal study is to answer the question of how to manage gummy smiles due to hypermobile upper lip with less invasive and low risk level procedure . This trial will help the practitioners and the patients in taking the convenient decision to correct the gumminess to restore lip-gingival-dental harmony… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gummy Smile Due to Hypermobile Upper Lip
- What is being tested?
- Botulinum Toxin A Injection and Modified Lip Repositioning Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Jun 2018
- Phase
- Early Phase 1
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults with age range from 18 - 30 years.
- Excessive gingival display more than 3 mm during smiling.
- Patients having hypermobile upper lip with or without (mild / moderate) vertical maxillary excess.
- Patients with normal morphology of clinical crowns.
- Normal lip separation (ILG) at rest
- Medically free subjects.
Who cannot join
- Patients with systemic diseases or neuromuscular disorders.
- Gummy smile with gingival display more than 8 mm during smiling.
- Severly long face (VME) patients.
- Patients with periodontal disease or gingival hyperplasia .
- Medically compromised patients contraindicated for surgery .
- Pregnant or lactating female patients.
- Patients with inadequate attached gingiva .
About this study
Official title: Satisfaction Of Adult Patients With Gummy Smile Treated By Botulinum Toxin A Injection Versus Modified Lip Repositioning Surgery : A Randomized Clinical Trial
The aim of the proposal study is to answer the question of how to manage gummy smiles due to hypermobile upper lip with less invasive and low risk level procedure . This trial will help the practitioners and the patients in taking the convenient decision to correct the gumminess to restore lip-gingival-dental harmony and enhance smile asthetics.
Read the detailed description
In this randomized clinical trial , two groups will be included to compare the effectiveness of a treatment modality of botulinum toxin-A injection , in the first group , on gingival display during smiling ,patient satisfaction , lower face esthetics ( upper lip length , upper lip vermillion length , interlabial gap , nasolabial angle) and the postoperative side effects . the comparator group will receive treatment by modified lip repositioning surgery ,to compare the results of the intervention group that can possibly obtained without undergoing surgery.
- Conditions
- Gummy Smile Due to Hypermobile Upper Lip
- Being tested
- Botulinum Toxin A Injection, Modified Lip Repositioning Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin A InjectionDrug
Also called BOTOX
adult patients with gummy smile due to hypermobile upper lip will receive Botulinum Toxin A Injection with a single injection1 cm lateral to the ala horizontally and 3 cm above the lip line vertically.
Modified Lip Repositioning SurgeryProcedure or surgery
the surgical procedure will be done by removal of strip of epithelium by careful dissection and stabilizing the new mucosal margin to the gingiva to improve the gingival display in adult patients with gummy smile.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin A Injection | Experimental | this group will receive Botulinum Toxin A Injection at doses of 2.5 or 5 IU (depending on the degree of gum exposure) on each side of the nasolabial fold with follow up at at 2,4,8,12 and 24 weeks. Receives: Drug: Botulinum Toxin A Injection |
| Modified Lip Repositioning Surgery | Experimental | this group will receive Modified Lip Repositioning Surgery with follow up at at 2,4,8,12 and 24 weeks. Receives: Procedure: Modified Lip Repositioning Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction and postoperative side effects
it will be assessed using Questionnaire.
Measured: at 4 weeks
Secondary outcomes (4)
Improvement of gingival display upon smiling
it will be assessed using Digital ruler on DSS software
Measured: at 4,8 and 12 weeks
Lower face esthatics: a) upper lip length b) upper lip- vermillion length c) interlabial gap
it will be assessed using Digital ruler and angle measurement on DSS software
Measured: at 4,8 and 12 weeks
Lower face esthatics: d)nasolabial angle
it will be assessed using Digital angle measurement on DSS software
Measured: at 4,8 and 12 weeks
stability of gummy smile correction.
it will be assessed using Digital ruler on DSS software
Measured: at the end of 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study startJun 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gummy Smile Due to Hypermobile Upper LipStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186547
- Sponsor's protocol ID
- CEBD-CU-2017-06-02
- Status last verified
- Jun 2017
- First submitted
- 11 Jun 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction Of Adult Patients With Gummy Smile Treated By Botulinum Toxin A Injection Versus Modified Lip Repositioning Surgery : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03186547
- Acronym / sponsor ID
- CEBD-CU-2017-06-02
- Conditions
- Gummy Smile Due to Hypermobile Upper Lip
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 14 Jun 2017 (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.
The aim of the proposal study is to answer the question of how to manage gummy smiles due to hypermobile upper lip with less invasive and low risk level procedure . This trial will help the practitioners and the patients in taking the convenient decision to correct the gumminess to restore lip-gingival-dental harmony and enhance smile asthetics.
Detailed description
In this randomized clinical trial , two groups will be included to compare the effectiveness of a treatment modality of botulinum toxin-A injection , in the first group , on gingival display during smiling ,patient satisfaction , lower face esthetics ( upper lip length , upper lip vermillion length , interlabial gap , nasolabial angle) and the postoperative side effects . the comparator group will receive treatment by modified lip repositioning surgery ,to compare the results of the intervention group that can possibly obtained without undergoing surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin A Injection | Experimental | Drug: Botulinum Toxin A Injectionthis group will receive Botulinum Toxin A Injection at doses of 2.5 or 5 IU (depending on the degree of gum exposure) on each side of the nasolabial fold with follow up at at 2,4,8,12 and 24 weeks. |
| Modified Lip Repositioning Surgery | Experimental | Procedure: Modified Lip Repositioning Surgerythis group will receive Modified Lip Repositioning Surgery with follow up at at 2,4,8,12 and 24 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults with age range from 18 - 30 years.
- Excessive gingival display more than 3 mm during smiling.
- Patients having hypermobile upper lip with or without (mild / moderate) vertical maxillary excess.
- Patients with normal morphology of clinical crowns.
- Normal lip separation (ILG) at rest
Key exclusion criteria (7 listed)
- Patients with systemic diseases or neuromuscular disorders.
- Gummy smile with gingival display more than 8 mm during smiling.
- Severly long face (VME) patients.
- Patients with periodontal disease or gingival hyperplasia .
- Medically compromised patients contraindicated for surgery .
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 |
|---|---|---|
| Botulinum Toxin A InjectionAlso: BOTOXadult patients with gummy smile due to hypermobile upper lip will receive Botulinum Toxin A Injection with a single injection1 cm lateral to the ala horizontally and 3 cm above the lip line vertically. | Drug | Botulinum Toxin A Injection |
| Modified Lip Repositioning Surgerythe surgical procedure will be done by removal of strip of epithelium by careful dissection and stabilizing the new mucosal margin to the gingiva to improve the gingival display in adult patients with gummy smile. | Procedure or surgery | Modified Lip Repositioning Surgery |
Primary outcome
Patient satisfaction and postoperative side effects
Time frame: at 4 weeks
it will be assessed using Questionnaire.
4 secondary outcomes
Improvement of gingival display upon smiling
Time frame: at 4,8 and 12 weeks
Lower face esthatics: a) upper lip length b) upper lip- vermillion length c) interlabial gap
Time frame: at 4,8 and 12 weeks
Lower face esthatics: d)nasolabial angle
Time frame: at 4,8 and 12 weeks
stability of gummy smile correction.
Time frame: at the end of 24 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Botulinum Toxin A Injection and Modified Lip Repositioning Surgery in people with Gummy Smile Due to Hypermobile Upper Lip, run by Cairo University.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Patient satisfaction and postoperative side effects (time frame: at 4 weeks). 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 20 Jun 2017.