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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05057286
Other study ID # 20338-DHYD
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 1, 2020
Est. completion date May 31, 2021

Study information

Verified date September 2021
Source University of Medicine and Pharmacy at Ho Chi Minh City
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Vietnam Faculty of Odontostomatology - University of Medicine and Pharmacy at Ho Chi Minh City Ho Chi Minh City

Sponsors (1)

Lead Sponsor Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gingival exposure The outcome is measured in millimeters based on photos of subjects included At the time before treatment (T0)
Primary Gingival exposure The outcome is measured in millimeters based on photos of subjects included Two months after clinical crown lengthening surgery (T1)
Primary Gingival exposure The outcome is measured in millimeters based on photos of subjects included Two weeks after Botulinum toxin A injection (T2)
Primary Gingival exposure The outcome is measured in millimeters based on photos of subjects included Two months after Botulinum toxin A injection (T2)
Primary Clinical crown length The clinical crown length is measured in millimeters using digital caliper and periodontal probe At the time before treatment (T0)
Primary 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)
Primary 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)
Primary 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)
See also
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Recruiting NCT05132010 - Prevalence of Gummy Smile and Its Causes Among the Egyptian Population.