NCT03812965 is a Phase 2 clinical trial of Botulinum toxin type A in Smiling, sponsored by Universidade Ibirapuera.

Who is sponsoring NCT03812965?

NCT03812965 is sponsored by Universidade Ibirapuera.

What drugs are being tested in NCT03812965?

Interventions in NCT03812965: Botulinum toxin type A.

Is NCT03812965 still recruiting?

NCT03812965 is currently completed. Last updated 5 June 2019.

Last reviewed 2019-06-05 · How we verify

NCT03812965

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Botulinum Toxin in the Treatment of Gingival Smile

Completed Phase 2 Last updated 5 June 2019

What this trial tests

Phase 2 trial testing Botulinum toxin type A in Smiling in 20 participants. Completed in 8 April 2019.

Timeline

1 August 2018

Primary endpoint
8 February 2019

8 April 2019

Quick facts

Lead sponsor	Universidade Ibirapuera
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	1 August 2018
Primary completion	8 February 2019
Estimated completion	8 April 2019
Sites	1 location across Brazil

Drugs / interventions tested

Botulinum toxin type A (BOTULINUM TOXIN TYPE A) — full drug profile →

Conditions studied

Smiling — all drugs for Smiling →

Sponsor

Universidade Ibirapuera

Who can join

Eligibility, any sex, with Smiling. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Botulinum Toxin Type A and Hyaluronic Acid Dermal Fillers in Dentistry: A Systematic Review of Clinical Application and Indications.
Maci M, Fanelli C, Lorusso M, Ferrara D, et al · · 2024 · cited 2× · PMID 39027812 · DOI 10.14740/jocmr5202

Verify or expand the search:

Other trials of Botulinum toxin type A

Trials testing the same drug.

NCT07236632 — Hyaluronic Acid vs Botulinum Toxin Injection in Treatment of Lifelong Drug-Resistant Premature Ejaculation: Randomized S · NA · not yet recruiting
NCT06448676 — Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides · Phase 4 · not yet recruiting
NCT06296082 — Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Sp · Phase 2, PHASE3 · recruiting
NCT06385171 — Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation · recruiting
NCT06465056 — Use of Botulinum Toxin A in Direct Eyebrow Lift Scar · Phase 2 · recruiting

Other Universidade Ibirapuera trials

Trials by the same sponsor.

NCT03827889 — Efficacy of Two Protocols for Applying Fluorine Varnish to Deciduous Teeth · NA · suspended
NCT03785769 — Pre-etching of Dentin Before Restorations With High Viscosity Glass Ionomer Cement · NA · withdrawn
NCT03785730 — Non-restorative Cavity Control in Anterior Cavitated Caries Lesion of Primary Teeth · NA · suspended
NCT04013659 — Effect of Gel Renewal During In-office Dental Bleaching · Phase 1 · unknown
NCT03044938 — Acute Effect of Salbutamol on Heart Rate and Blood Pressure During Exercise in Patients With Moderate or Severe Asthma a · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03812965 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universidade Ibirapuera
Last refreshed: 5 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03812965.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing