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NCT ID: NCT05127018 Completed - Clinical trials for Botulinum Toxins, Type A

Higher Doses of Botulinum Toxin in the Treatment of Gummy Smile

Start date: November 20, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Botulinum type A (BTX-A) is an easy and efficacious treatment for gingival smile (GS). However, the necessary for higher-doses among patients are controversial. The objective was to compare the reduction of gingival exposure using two methods in patients with different dosage. In this prospective self-controlled study, healthy GS participates who had an anterior gingival exposure (GE) of more than 3 mm were enrolled and administered with 2-5 U BTX-A (total, 4-10 U) injections into 1-2 points according to the severity presented pretreatment in the Average-dose Method. And after 8 months, the Higher-doses Method was administered the same point injection of 3-10 U BTX-A (total, 6-20 U). Data were collected at baseline and 4, 12, 32 and 60 weeks of follow-up.

NCT ID: NCT04820543 Completed - Clinical trials for Botulinum Toxins, Type A

Effects of Dose and Injection Site for Gummy Smile Treatment With Botulinum Type A

Start date: February 20, 2019
Phase: Phase 4
Study type: Interventional

Botulinum type A (BTX-A) is an easy and efficacious treatment for gingival smile (GS). However, its dosage and injection sites effect among patients are controversial.The objective was to compare the reduction of gingival exposure using two methods in patients with different dosage and injection sites. In this prospective self-controlled study, healthy GS participates who had an anterior gingival exposure (GE) of more than 3 mm were enrolled and administered single-point injection of 2 U BTX-A per side in the Simplified Method. And after 8 months, the Individualized Method was administered with 2-5 U BTX-A (total, 4-10 U) injections into 1-2 points according to the severity presented pretreatment. Data were collected at baseline and 4, 12, and 32 weeks of follow-up.

NCT ID: NCT04527744 Completed - Clinical trials for Botulinum Toxins, Type A

Application of Botulinum Toxin at the Yonsei Point for the Treatment of Gummy Smile

Start date: October 17, 2020
Phase: N/A
Study type: Interventional

The purpose of the present study will be to evaluate the efficacy of a single dose of botulinum toxin (BTX) at the Yonsei point for the treatment of gummy smile (GS). In this double-blind single-site randomized clinical trial, A total number of 36 patients with gummy smile will be enrolled in the study at Peking University School and Hospital of Stomatology over a period of 12 months. Patients will be included and randomized 1:1 to two groups for BTX-A treatment at different injection point. For experimental group, Three units of onabotulinumtoxinA (BTX-A) per site (90 hemifaces) will be initially injected at the Yonsei point. For control group,the same dose of BTX will be injected into the levator labii superioris alaeque nasi muscle, and the injection point is located 3 to 5 mm lateral to each nostril, which was a classical injection point of this treatment. The patients will be then assessed at 2, 4, 12, 36 and 72 weeks postinjection. All subjects underwent standardized measurements by a single examiner, including dynamic and static measurements and a lateral cephalometric radiograph. In addition, facial photos and videos and a questionnaire of self-assessment will be obtained. The primary outcome measurement is the anterior gingival exposure measurements when the subject get an achieve full, unrestricted, spontaneous smiles 2 weeks postinjection.

NCT ID: NCT03812965 Completed - Smiling Clinical Trials

Botulinum Toxin in the Treatment of Gingival Smile

Start date: August 1, 2018
Phase: Phase 2
Study type: Interventional

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.