Clinical trial NCT05057286: Effect of Clinical Crown Lengthening Surgery and Botulinum Toxin A Injection in Gummy Smile Treatment
Official title: The Effect of a Combination Between Clinical Crown Lengthening Surgery and Botulinum Toxin A Injection in Gummy Smile Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gummy Smile
Keywords: Gingival exposure
Clinical crown length
clinical crown lengthening surgery
Botulinum toxin A
Gummy smile
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Gingival exposure
timeFrame: At the time before treatment (T0)
measure: Gingival exposure
timeFrame: Two months after clinical crown lengthening surgery (T1)
measure: Gingival exposure
timeFrame: Two weeks after Botulinum toxin A injection (T2)
measure: Gingival exposure
timeFrame: Two months after Botulinum toxin A injection (T2)
measure: Clinical crown length
timeFrame: At the time before treatment (T0)
measure: Clinical crown length
timeFrame: Two months after clinical crown lengthening surgery (T1)
measure: Clinical crown length
timeFrame: Two weeks after Botulinum toxin A injection (T2)
measure: Clinical crown length
timeFrame: Two months after Botulinum toxin A injection (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Faculty of Odontostomatology - University of Medicine and Pharmacy at Ho Chi Minh City
Study officials:
References: