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OpenTrials
Completed

NCT Number: NCT03812965

Botulinum Toxin in the Treatment of Gingival Smile

Objective: to evaluate the effect of two gingival smile treatment techniques using botulinum toxin. Materials and methods: The randomized, double-blind clinical trial (patient and examiner) will be conducted by two trained and calibrated dentists. Ten patients will be randomly assigned to each group, in a total of 20 patients with gingiva smile greater than or equal to 3mm. In group 1, 10 patients will receive 2 units/point of botulinum toxin Botulift® (botulinum toxin type A), in the muscles form the face: Levators labii superioris alaeque nasi muscle and Levators labii superioris muscle, totalizing 4 points. In group 2, 2 units/point was injected in the muscles: levators labii superioris alaeque nasi muscle, totalizing 2 points. The amount of exposed gingiva during smile will be measured using a pachymeter and the muscle activity of the region will be evaluated through electromyography, before and after treatment (2, 8, 12, 21 and 25 weeks). Patient satisfaction and discomfort due to treatment will be evaluated in the same periods through questionnaire. The impact of the treatment in life quality will be evaluated through OHIP-14 questionnaire.

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Key information

Conditions

Smiling Behavior Communication Facial Expression Nonverbal Communication

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universidade Ibirapuera

São Paulo, 04661-100, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients of both genders exhibiting gingival exposure greater than or equal to 3 mm above the central incisor during smile
  • Patients with good general health and good oral hygiene.

Exclusion criteria

  • Patients with Botulinum Toxin allergy or albumin, or who have previously performed botulinum toxin facial treatment previously.
  • Patients with Amyotrophic Lateral Sclerosis, Neuropathy, Myasthenia Gravis or Lambert-Eaton Syndrome, women who are pregnant or planning to become pregnant, are breastfeeding women.
  • Patients who are participating in other research involving other drugs.
  • Patients who use drugs that interfere with neuromuscular transmission

Treatment and study plan

Botulinum Toxin Type A

Drug

2 units/point of botulinum toxin type A

Primary outcomes

  1. Exposed Gingiva during Smile (mm)

    Time frame: Before Treatment

    Measurement of exposed gingiva during smile using a pachymeter

  2. Exposed Gingiva during Smile (mm)

    Time frame: After Treatment (2 weeks)

    Measurement of exposed gingiva during smile using a pachymeter

  3. Exposed Gingiva during Smile (mm)

    Time frame: After Treatment (8 weeks)

    Measurement of exposed gingiva during smile using a pachymeter

  4. Exposed Gingiva during Smile (mm)

    Time frame: After Treatment (12 weeks)

    Measurement of exposed gingiva during smile using a pachymeter

  5. Exposed Gingiva during Smile (mm)

    Time frame: After Treatment (21 weeks)

    Measurement of exposed gingiva during smile using a pachymeter

  6. Exposed Gingiva during Smile (mm)

    Time frame: After Treatment (25 weeks)

    Measurement of exposed gingiva during smile using a pachymeter

Secondary outcomes

  1. Muscles Activity

    Time frame: Before Treatment

    Muscles activity using electromyography

  2. Muscles Activity

    Time frame: After Treatment (2 weeks)

    Muscles activity using electromyography

  3. Muscles Activity

    Time frame: After Treatment (8 weeks)

    Muscles activity using electromyography

  4. Muscles Activity

    Time frame: After Treatment (12 weeks)

    Muscles activity using electromyography

  5. Muscles Activity

    Time frame: After Treatment (21 weeks)

    Muscles activity using electromyography

  6. Muscles Activity

    Time frame: After Treatment (25 weeks)

    Muscles activity using electromyography

Sponsors and collaborators

Lead sponsor

Universidade Ibirapuera

Other

Registry information

Official study title

Effectiveness and Durability of Botulinum Toxin Application in the Treatment of Gingival Smile

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2019
Registry last updated
Jun 5, 2019

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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