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Clinical Trials/NCT05057286
NCT05057286
Completed
Phase 4

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

University of Medicine and Pharmacy at Ho Chi Minh City1 site in 1 country20 target enrollmentAugust 1, 2020
ConditionsGummy Smile

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Gummy Smile
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Enrollment
20
Locations
1
Primary Endpoint
Clinical crown length
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
May 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Responsible Party
Principal Investigator
Principal Investigator

Nguyen Thu Thuy

Deputy Head of Department of Periodontology

University of Medicine and Pharmacy at Ho Chi Minh City

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Gingival exposure

Time Frame: Two months after Botulinum toxin A injection (T2)

The outcome is measured in millimeters based on photos of subjects included

Study Sites (1)

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