Effect of Clinical Crown Lengthening Surgery and Botulinum Toxin A Injection in Gummy Smile Treatment

Gummy Smile Clinical Trial

Official title:

The Effect of a Combination Between Clinical Crown Lengthening Surgery and Botulinum Toxin A Injection in Gummy Smile Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05057286
• Other study ID #: 20338-DHYD
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Gummy Smile

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Vietnam	Faculty of Odontostomatology - University of Medicine and Pharmacy at Ho Chi Minh City	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival exposure	The outcome is measured in millimeters based on photos of subjects included	At the time before treatment (T0)
Primary	Gingival exposure	The outcome is measured in millimeters based on photos of subjects included	Two months after clinical crown lengthening surgery (T1)
Primary	Gingival exposure	The outcome is measured in millimeters based on photos of subjects included	Two weeks after Botulinum toxin A injection (T2)
Primary	Gingival exposure	The outcome is measured in millimeters based on photos of subjects included	Two months after Botulinum toxin A injection (T2)
Primary	Clinical crown length	The clinical crown length is measured in millimeters using digital caliper and periodontal probe	At the time before treatment (T0)
Primary	Clinical crown length	The clinical crown length is measured in millimeters using digital caliper and periodontal probe	Two months after clinical crown lengthening surgery (T1)
Primary	Clinical crown length	The clinical crown length is measured in millimeters using digital caliper and periodontal probe	Two weeks after Botulinum toxin A injection (T2)
Primary	Clinical crown length	The clinical crown length is measured in millimeters using digital caliper and periodontal probe	Two months after Botulinum toxin A injection (T2)