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

NCT05057286 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-09-27

No results posted yet for this study

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.

Conditions

  • Gummy Smile

Interventions

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.

Sponsors & Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-05-31
Completion
2021-05-31
FDA Drug
Yes

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05057286 on ClinicalTrials.gov