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Completed

NCT Number: NCT05057286

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

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.

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Key information

Conditions

Gummy Smile

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Ho Chi Minh City, 749000, Vietnam

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical crown lengthening surgery

Procedure
  • 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

Primary outcomes

  1. Gingival exposure

    Time frame: At the time before treatment (T0)

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

  2. Gingival exposure

    Time frame: Two months after clinical crown lengthening surgery (T1)

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

  3. Gingival exposure

    Time frame: Two weeks after Botulinum toxin A injection (T2)

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

  4. Gingival exposure

    Time frame: Two months after Botulinum toxin A injection (T2)

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

  5. Clinical crown length

    Time frame: At the time before treatment (T0)

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

  6. Clinical crown length

    Time frame: Two months after clinical crown lengthening surgery (T1)

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

  7. Clinical crown length

    Time frame: Two weeks after Botulinum toxin A injection (T2)

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

  8. Clinical crown length

    Time frame: Two months after Botulinum toxin A injection (T2)

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

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2021
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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