NCT05057286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

September 7, 2021

Last Update Submit

September 15, 2021

Conditions

Gummy Smile

Keywords

Gingival exposureClinical crown lengthclinical crown lengthening surgeryBotulinum toxin AGummy smile

Outcome Measures

Primary Outcomes (8)

  • Gingival exposure

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

    At the time before treatment (T0)

  • Gingival exposure

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

    Two months after clinical crown lengthening surgery (T1)

  • Gingival exposure

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

    Two weeks after Botulinum toxin A injection (T2)

  • Gingival exposure

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

    Two months after Botulinum toxin A injection (T2)

  • Clinical crown length

    The clinical crown length is measured in millimeters using digital caliper and periodontal probe

    At the time before treatment (T0)

  • 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)

  • 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)

  • 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)

Study Arms (1)

Subjects with gummy smile

EXPERIMENTAL

The study procedure consisted of recruitment, pre\&post-operative photography, gingivoplasty, BTX-A injection, recall visits, and data collecting.

Procedure: Clinical crown lengthening surgery

Interventions

Clinical crown lengthening surgeryPROCEDURE

* 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.

Also known as: Botulinum toxin A injection
Subjects with gummy smile

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Odontostomatology - University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 749000, Vietnam

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Participants were recruited from patients who came for chief complaint of excess gingival display at the Dental Clinic of the Faculty of Odonto-stomatology, University of medicine and Pharmacy at Ho Chi Minh City. The study population included patients aged from eighteen years with an average length of excessive gingival display ≥ of 4 mm when maximum smiling (counted eight teeth, from the 14 to the 24 teeth) and the height of keratinized gingiva ≥ 3 mm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Head of Department of Periodontology

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 27, 2021

Study Start

August 1, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)