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To compare Botox and Hyaluronic acid filler when given to patients with post Orthodontic treatment to improve the gummy smile

Comparison of effectiveness, duration and patient’s satisfaction of Botulinum toxin A and Hyaluronic filler in the treatment of gummy smile :An in-vivo study - NILL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061551
Enrollment
14
Registered
2024-01-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified

Interventions

Intervention1: Group A - Botulinum Toxin A: Dose : total 5 units of BTX -A ( 2.5U per side) Frequency: once Route of administration: intramuscular ( IM) Total duration of intervention : 90 days
(ii) levator labii superioris and zygomaticus minor muscles on each side of the face. This is roughly about 1 cm lateral and below the nasal ala on each side of the nasal fold. A skin marker will be u
B – midpoint of the line connecting the gingival margins of maxillary central incisors .The gingival display will be measured using a scale and a Vernier calliper for precise measurements between two

Sponsors

Dr Truppti P Sonone
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Patients with gummy smile more than 3 mm. • No history of previous treatment for correction of gummy smile. • Patients wanting aesthetic smile correction without surgery.

Exclusion criteria

Exclusion criteria: 1.History of neuromuscular disorder 2. Patients allergic to Botolium toxin A and B 3. Patients taking medications that might interfere with the neuromuscular impulse transmission and potentiate the effects of Botolium toxin. 4. Patients who are mentally / physically not stable

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness, duration and patients satisfaction by Botulinum Toxin A and Hyaluronic filler in gummy smile patientsTimepoint: Each patient will be observed for 3months for the study purpose

Secondary

MeasureTime frame
To access the stability of duration of gummy smile correction, post-administration of Botox -A at the end of 30th , 60th and 90th day.Timepoint: 1 month;To access the stability of duration of gummy smile correction, post-administration of Hyaluronic acid Filler at the end of 30th , 60th and 90th day.Timepoint: 1 month;To assess the effectiveness in correction of gummy smile post administration of botox A immediately after 14th dayTimepoint: 1month;To assess the effectiveness in correction of gummy smile post administration of Hyaluronic acid Filler immediately after 14th dayTimepoint: 1month;To assess the gingival display pre and post treatment after administration of Botox -ATimepoint: 3 months;To assess the gingival display pre and post treatment after administration of Hyaluronic acid fillerTimepoint: 3 months;To evaluate patients satisfaction in administration of Botox -ATimepoint: 3 months;To evaluate patients satisfaction in administration of Hyaluronic acid fillerTimepoint: 3 months

Countries

India

Contacts

Public ContactDr Chetan Patil

D.Y.Patil School of Dentistry, Nerul, Navi Mumbai

trupptisonone@gmail.com8909999928

Outcome results

None listed

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