Effect of Clinical Crown Lengthening Surgery and Botulinum Toxin A Injection in Gummy Smile Treatment
NCT ID: NCT05057286
Last Updated: 2021-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2020-08-01
2021-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Subjects with gummy smile
The study procedure consisted of recruitment, pre\&post-operative photography, gingivoplasty, BTX-A injection, recall visits, and data collecting.
Clinical crown lengthening surgery
* 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.
Interventions
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Clinical crown lengthening surgery
* 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Short clinical crown of teeth due to the altered passive tooth eruption
* Hyperactivity of upper lip muscles (lip mobility level \> 8mm)
Exclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University of Medicine and Pharmacy at Ho Chi Minh City
OTHER
Responsible Party
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Nguyen Thu Thuy
Deputy Head of Department of Periodontology
Locations
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Faculty of Odontostomatology - University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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20338-DHYD
Identifier Type: -
Identifier Source: org_study_id
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