Gummy SmilePhase 4NCT05057286
Effect of Clinical Crown Lengthening Surgery and Botulinum Toxin A Injection in Gummy Smile Treatment
A Phase 4 study testing Clinical crown lengthening surgery in people with Gummy Smile, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
Background: The demand for beauty is increasing in society as everyone is looking for cosmetic improvement, including gummy smile correction. Object: This study aims to evaluate the efficacy of a combination of a clinical tooth crowns lengthening surgery following by a BTX-A injection in gummy smile treatment upon… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gummy Smile
- What is being tested?
- Clinical crown lengthening surgery
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2020to 31 May 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gummy smile because of 2 combined etiologies:
- Short clinical crown of teeth due to the altered passive tooth eruption
- Hyperactivity of upper lip muscles (lip mobility level > 8mm)
Who cannot join
- Pregnant or breastfeeding patients
- Gummy smiles due to:
- Maxillary bone overgrowth (maxillary hypertrophy)
- Vertical maxillary excess
- Neuromuscular disorder
- Gingival hyperplasia due to medicine, supplements, or neuromuscular transmission inhibiting agents
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- Systematic diseases that can affect the result of surgical treatment (such as diabetes, heart disease taking blood anticoagulant medicament, blood diseases, immunodeficiency disease etc.)
- Allergy to BTX-A or albumin
- History of taking BTX-A injection in the head-neck area formerly
- Patient with any contraindication of surgery
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Odontostomatology - University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 749000
About this study
Official title: The Effect of a Combination Between Clinical Crown Lengthening Surgery and Botulinum Toxin A Injection in Gummy Smile Treatment
Background: The demand for beauty is increasing in society as everyone is looking for cosmetic improvement, including gummy smile correction.
Object: This study aims to evaluate the efficacy of a combination of a clinical tooth crowns lengthening surgery following by a BTX-A injection in gummy smile treatment upon based on clinical assessment and photography
Method: An uncontrolled longitudinal study was implemented at the Faculty of Odonto-Stomatology (FOS) of the University of Medicine and Pharmacy at Ho Chi Minh City (UMPH), Viet Nam, from August 2020 to May 2021. Twenty patients (19 females and one male) at a mean age of 24 years old who came for gummy smile chief complaint were included in the study. Subjects were operated to lengthen the clinical crown following an additional botulinum toxin A injection two months post-surgery. All the participants answered the smile esthetic satisfactory questions and were photographed at the time before treatment (T0), two months after clinical crown lengthening surgery (T1), two weeks (T2), and two months (T3) follow-up visits after BTX-A injection. The gingival exposure (GE) and clinical crown length (CCL) were measured at each time point for analysis.
- Conditions
- Gummy Smile
- Being tested
- Clinical crown lengthening surgery
- Keywords
- Gingival exposure, Clinical crown length, clinical crown lengthening surgery, Botulinum toxin A, Gummy smile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical crown lengthening surgeryProcedure or surgery
Also called Botulinum toxin A injection
- Clinical dental crown lengthening surgery protocol: a clinical crown lengthening surgery was performed.
- Post-operation protocol Patients were all prescribed antibiotics , anti-inflammation, analgesic, and an antiseptic mouthwash. Patients were instructed for oral hygiene and recalls.
- Botulinum Toxin A injection One hundred units (U) of botulinum toxin A (BTX-A) were diluted with 2.5ml of sterile saline solution without shaking. 1 mm syringe with a 30-gauge needle was used to get 0.25ml BTX-A for four-point injection, or 0.6ml in case injection of 6 points. Cold compress was applied extraoral 5 mins at injection site before injection.
After local anesthesia, the doctor administered slowly 2,5 U of diluted BTX-A at each point until white cellulite appeared.
Patients were recalled two weeks (T2), and two months (T3) after injection.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with gummy smile | Experimental | The study procedure consisted of recruitment, pre\&post-operative photography, gingivoplasty, BTX-A injection, recall visits, and data collecting. Receives: Procedure: Clinical crown lengthening surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival exposure
The outcome is measured in millimeters based on photos of subjects included
Measured: At the time before treatment (T0)
Gingival exposure
The outcome is measured in millimeters based on photos of subjects included
Measured: Two months after clinical crown lengthening surgery (T1)
Gingival exposure
The outcome is measured in millimeters based on photos of subjects included
Measured: Two weeks after Botulinum toxin A injection (T2)
Gingival exposure
The outcome is measured in millimeters based on photos of subjects included
Measured: Two months after Botulinum toxin A injection (T2)
Clinical crown length
The clinical crown length is measured in millimeters using digital caliper and periodontal probe
Measured: At the time before treatment (T0)
Clinical crown length
The clinical crown length is measured in millimeters using digital caliper and periodontal probe
Measured: Two months after clinical crown lengthening surgery (T1)
Clinical crown length
The clinical crown length is measured in millimeters using digital caliper and periodontal probe
Measured: Two weeks after Botulinum toxin A injection (T2)
Clinical crown length
The clinical crown length is measured in millimeters using digital caliper and periodontal probe
Measured: Two months after Botulinum toxin A injection (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Aug 2020
- Primary completion31 May 2021
- Study completion31 May 2021
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.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants were recruited from patients who came for chief complaint of excess gingival display at the Dental Clinic of the Faculty of Odonto-stomatology, University of medicine and Pharmacy at Ho Chi Minh City. The study population included patients aged from eighteen years with an average length of excessive gingival display ≥ of 4 mm when maximum smiling (counted eight teeth, from the 14 to the 24 teeth) and the height of keratinized gingiva ≥ 3 mm.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Thu Thuy, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057286
- Sponsor's protocol ID
- 20338-DHYD
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Combination Between Clinical Crown Lengthening Surgery and Botulinum Toxin A Injection in Gummy Smile Treatment
- ClinicalTrials.gov ID
- NCT05057286
- Acronym / sponsor ID
- 20338-DHYD
- Conditions
- Gummy Smile
- Keywords
- Gingival exposure, Clinical crown length, clinical crown lengthening surgery, Botulinum toxin A, Gummy smile
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 27 Sep 2021 (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.
Background: The demand for beauty is increasing in society as everyone is looking for cosmetic improvement, including gummy smile correction.
Object: This study aims to evaluate the efficacy of a combination of a clinical tooth crowns lengthening surgery following by a BTX-A injection in gummy smile treatment upon based on clinical assessment and photography
Method: An uncontrolled longitudinal study was implemented at the Faculty of Odonto-Stomatology (FOS) of the University of Medicine and Pharmacy at Ho Chi Minh City (UMPH), Viet Nam, from August 2020 to May 2021. Twenty patients (19 females and one male) at a mean age of 24 years old who came for gummy smile chief complaint were included in the study. Subjects were operated to lengthen the clinical crown following an additional botulinum toxin A injection two months post-surgery. All the participants answered the smile esthetic satisfactory questions and were photographed at the time before treatment (T0), two months after clinical crown lengthening surgery (T1), two weeks (T2), and two months (T3) follow-up visits after BTX-A injection. The gingival exposure (GE) and clinical crown length (CCL) were measured at each time point for analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants were recruited from patients who came for chief complaint of excess gingival display at the Dental Clinic of the Faculty of Odonto-stomatology, University of medicine and Pharmacy at Ho Chi Minh City. The study population included patients aged from eighteen years with an average length of excessive gingival display ≥ of 4 mm when maximum smiling (counted eight teeth, from the 14 to the 24 teeth) and the height of keratinized gingiva ≥ 3 mm.
| Arm | Type | Receives |
|---|---|---|
| Subjects with gummy smile | Experimental | Procedure: Clinical crown lengthening surgeryThe study procedure consisted of recruitment, pre\&post-operative photography, gingivoplasty, BTX-A injection, recall visits, and data collecting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gummy smile because of 2 combined etiologies:
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding patients
- Gummy smiles due to:
- Systematic diseases that can affect the result of surgical treatment (such as diabetes, heart disease taking blood anticoagulant medicament, blood diseases, immunodeficiency disease etc.)
- Allergy to BTX-A or albumin
- History of taking BTX-A injection in the head-neck area formerly
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 |
|---|---|---|
| Clinical crown lengthening surgeryAlso: Botulinum toxin A injection* Clinical dental crown lengthening surgery protocol: a clinical crown lengthening surgery was performed. * Post-operation protocol Patients were all prescribed antibiotics , anti-inflammation, analgesic, and an antiseptic mouthwash. Patients were instructed for oral hygiene and recalls. * Botulinum Toxin A injection One hundred units (U) of botulinum toxin A (BTX-A) were diluted with 2.5ml of sterile saline solution without shaking. 1 mm syringe with a 30-gauge needle was used to get 0.25ml BTX-A for four-point injection, or 0.6ml in case injection of 6 points. Cold compress was applied extraoral 5 mins at injection site before injection. After local anesthesia, the doctor administered slowly 2,5 U of diluted BTX-A at each point until white cellulite appeared. Patients were recalled two weeks (T2), and two months (T3) after injection. | Procedure or surgery | Subjects with gummy smile |
Primary outcome
Gingival exposure
Time frame: At the time before treatment (T0)
The outcome is measured in millimeters based on photos of subjects included
Gingival exposure
Time frame: Two months after clinical crown lengthening surgery (T1)
The outcome is measured in millimeters based on photos of subjects included
Gingival exposure
Time frame: Two weeks after Botulinum toxin A injection (T2)
The outcome is measured in millimeters based on photos of subjects included
Gingival exposure
Time frame: Two months after Botulinum toxin A injection (T2)
The outcome is measured in millimeters based on photos of subjects included
Clinical crown length
Time frame: At the time before treatment (T0)
The clinical crown length is measured in millimeters using digital caliper and periodontal probe
Clinical crown length
Time frame: Two months after clinical crown lengthening surgery (T1)
The clinical crown length is measured in millimeters using digital caliper and periodontal probe
Clinical crown length
Time frame: Two weeks after Botulinum toxin A injection (T2)
The clinical crown length is measured in millimeters using digital caliper and periodontal probe
Clinical crown length
Time frame: Two months after Botulinum toxin A injection (T2)
The clinical crown length is measured in millimeters using digital caliper and periodontal probe
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 27 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Gummy Smile
Not yet recruiting
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Not yet recruitingObservational study
Decision Regret Following Yonsei-Point Botulinum Toxin for Gummy Smile
Excessive Gingival Display
Recruiting
Periodontal Tissue Stability After Surgical Correction of Altered Passive Eruption
Altered Passive Eruption
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Evaluating AI for Diagnosing and Treating Gummy Smiles: A Pilot Study
Gummy Smile, Artifical Intelligence
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Gummy Smile and Altered Passive Eruption Prevalence
Altered Passive Eruption of Teeth
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clinical crown lengthening surgery in people with Gummy Smile, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 3 inclusion and 10 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 27 Sep 2021. 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 Vietnam. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Gingival exposure (time frame: At the time before treatment (T0)). The study lists 8 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 27 Sep 2021.