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

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City (Other)

Overall Status

Completed

CT.gov ID

NCT05057286

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gummy Smile	Procedure: Clinical crown lengthening surgery	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2020

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects with gummy smile The study procedure consisted of recruitment, pre&post-operative photography, gingivoplasty, BTX-A injection, recall visits, and data collecting.	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. Other Names: Botulinum toxin A injection

Arm

Intervention/Treatment

Experimental: Subjects with gummy smile

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

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.

Other Names:

Botulinum toxin A injection

Outcome Measures

Primary Outcome Measures

Gingival exposure [At the time before treatment (T0)]
The outcome is measured in millimeters based on photos of subjects included
Gingival exposure [Two months after clinical crown lengthening surgery (T1)]
The outcome is measured in millimeters based on photos of subjects included
Gingival exposure [Two weeks after Botulinum toxin A injection (T2)]
The outcome is measured in millimeters based on photos of subjects included
Gingival exposure [Two months after Botulinum toxin A injection (T2)]
The outcome is measured in millimeters based on photos of subjects included
Clinical crown length [At the time before treatment (T0)]
The clinical crown length is measured in millimeters using digital caliper and periodontal probe
Clinical crown length [Two months after clinical crown lengthening surgery (T1)]
The clinical crown length is measured in millimeters using digital caliper and periodontal probe
Clinical crown length [Two weeks after Botulinum toxin A injection (T2)]
The clinical crown length is measured in millimeters using digital caliper and periodontal probe
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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