Clinical evaluation of botulinum toxin type A for management of gummy smile in post orthodontic patients: a comparative study of two injection techniques

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Botulinum toxin Type A injection using Yonsei point technique: Intramuscular injection of Botulinum toxin Type A at the Yonsei point for correction of excessive gingival display in post‐orthodontic patients. A standardized dosage of botulinum toxin will be used in all patients. Clinical outcomes will be evaluated at predetermined follow‐up intervals. Control Intervention1: Botulinum toxin type A injection targeting levator labii superioris aleque nasi muscle.: Intramuscular injection of Botulinum toxin type A into the levator labii superioris alaeque nasi muscle using the muscle‐specific injection technique. Dose and dilution will be identical to the intervention group. Clinical outcomes will be evaluated at predetermined follow‐up intervals. CONDITION: PRIMARY OUTCOME: Maximal gingival display in millimeters ; measured during posed full smile using standardized frontal photographs at baseline i.e., pre‐injection and at follow‐up intervals after botulinum toxin injection. The amount of gingival exposure will be recorded using calibrated digital measurement tools.Timepoint: Pre‐injection ; At 2 weeks ; At 3 months SECONDARY OUTCOME: PATIENT SATISFACTION ‐ Evaluated using a structured questionnaire assessing patient perception of smile improvement and overall satisfaction following treatment.Timepoint: At 3 months SMILE ESTHETICS ‐ Assessed by evaluating changes in gingival display and overall smile appearance following botulinum toxin injection.Timepoint: Pre‐injection and At 3 months interval Willingness to undergo repeat botulinum toxin treatment ‐ Assessed based on patient response regarding acceptance of repeat botulinum toxin injections if required in the future.Timepoint: At 3 months INCLUSION CRITERIA: Patients greater than or equal to 18 yrs of age. Gingival display of greater than or equal to 3mm during posed full smile.
Epistemonikos ID: fbe46842506ba2d4edc96b916e319529638c7993
First added on: Oct 08, 2026