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Using local anesthesia to temporarily correct a gummy smile by adjusting lip movement, allowing patients to compare its effects with Botox (lasting six months) and make an informed decision about Botox treatment.

Local anesthesia as a temporary modulator of lip dynamics in gummy smile correction a dose based comparison with botox for predictable patient outcome. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084916
Enrollment
50
Registered
2025-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: LOCAL ANESTHESIA AND BOTULINUM TOXIN A INJECTION: Gummy smile patients (age range 18-35 years) with hypertonic upper lip and gingival display more than 3 mm reporting to the dept. of or

Sponsors

Dr Anmol Sharma
Lead Sponsor
Professor Dr MS Ravi
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Excessive gingival display (more than 3 mm) With hypertonic upper lip 2.Healthy patient with no underlying systemic diseases or illness. 3.Not on any medications that may alter the oral cavity status. 4.No craniofacial anomalies such as cleft lip or palate.

Exclusion criteria

Exclusion criteria: 1.Individuals with systemic illness 2.Gummy smile patients with hypotonic upper lip/ hypertonic upper lip undergoing active orthodontic treatment. 3.Patients on CCBs / Aminoglycosides/Cyclosporine 4.Neuromuscular disorder patients 5.Pregnant females 6.Unwilling individuals 7.Individual allergic to local anesthesia/botox/saline. 8.Ulcers/cuts in the oral cavity, Herpes labialis 9.Acute or chronic inflammation of lips / oral cavity 10.Nasal defects and infections

Design outcomes

Primary

MeasureTime frame
The study aims to perform a comparative assessment of local anesthesia , verses the botulinum toxin , focusing on their impact on upper lip elevation, smile symmetry, duration of effect, and patient-reported satisfaction. SO the primary outcome of the research would be to establish scientifically validated dosing protocols for both interventions to enhance the predictability and clinical outcomes in the correction of gummy smiles. Timepoint: on the first day, first dose of local anesthesia injected and photograph taken after 5 minutes. second dose of local anesthesia injected and photograph taken after 5 minutes. third dose of local anesthesia injected and photograph taken after 5 mintues. so its 5 minutes,5 minutes ,5 minutes (on the first day ) After 3 days , botulinum toxin A will be injected and assessment done at : 30 minutes, 1 week , 4 weeks , 6 months

Secondary

MeasureTime frame
this study pertains to sustainable development goal (SDG) NO. 3Timepoint: Assessment done at : 5 minutes, 5 minutes , 5 minutes after injecting the local anesthesia (on day 1 ) Assessment done at : 30 MINUTES, 1 WEEK , 4 WEEKS , 6 MONTHS after injecting the botulinum toxin A (on day 3 )

Countries

India

Contacts

Public ContactDrMS Ravi

AB Shetty Memorial institute of dental sciences

kuttappa27@gmail.com9845152712

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026