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

Phase 4

Completed

• Conditions: Gummy Smile
• Interventions: Procedure: Clinical crown lengthening surgery

• Registration Number: NCT05057286
• Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-09
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-15
• Last Update Submitted: 2021-09-15
• Study First Posted: 2021-09-27
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with gummy smile	Clinical crown lengthening surgery	The study procedure consisted of recruitment, pre\&post-operative photography, gingivoplasty, BTX-A injection, recall visits, and data collecting.

Primary Outcome Measures

Name	Time	Method
Clinical crown length	Two months after Botulinum toxin A injection (T2)	The clinical crown length is measured in millimeters using digital caliper and periodontal probe
Gingival exposure	Two months after Botulinum toxin A injection (T2)	The outcome is measured in millimeters based on photos of subjects included

Trial Locations

Locations (1)

Faculty of Odontostomatology - University of Medicine and Pharmacy at Ho Chi Minh City; 🇻🇳 Ho Chi Minh City, Vietnam