Effect of Cross-linked Hyaluronic Acid Filler Versus Botulinum Toxin Type A (Botox) in Management of Gummy Smile

NCT06952218 | Not Yet Recruiting

• 1 other identifier: 5699269
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

A smile is supposed to express one's feelings and expressions, for that there has been an awakening concern for the appearance of gummy smile. Gummy smile is the appearance of about 2mm or more of the gingiva during smiling. It may affect the quality of life of individuals affecting their self-esteem; patients desire to look good not only while resting but while dynamically expressing themselves too. Variable factors contribute to this gingival display whether skeletal, dental or muscular. Variable treatment modalities are done solely or in adjunction to each other for the treatment of gummy smile including both surgical or nonsurgical procedures.

Conditions

Gummy Smile Due to Hypermobile Upper Lip

Outcome Measures

Primary Outcomes (1)

• Gingival display

  will be measured from a point denoting the lowest margin of the upper lip perpendicular and superior to the midportion of the gingival margin of the maxillary lateral incisor to the gingival margin at the midpoint of the maxillary lateral incisor. The midpoint of the incisal edge of the maxillary lateral incisor will be used as a reference point if the upper lip fell below the gingival margin of the same tooth post-injection (Diaspro, Cavallini et al. 2018).

  week 2, month 1, month 3, month 6, month 9

Secondary Outcomes (3)

• Patient satisfaction

  week 2, month 1, month 3, month 6, month 9

• Postoperative pain

  week 2, month 1, month 3, month 6, month 9

• Lip mobility

  week 2, month 1, month 3, month 6, month 9

Study Arms (2)

Group I will receive botulinum toxin type A injection.

ACTIVE COMPARATOR

Injection site will be determined at a point in which the elevator muscles of the upper lip which are levator labii superioris, levator labii superioris alaeque nasi, and zygomaticus minor converge into the lateral area of the ala of the nose. The center of intersection of the mentioned muscles is termed Yonsei Point and estimated to be at a 1cm horizontal distance from the ala of the nose and a 3cm vertical distance from the lip line. Lidocaine 5% ointment will be applied to the intended injection site for 20 mins. In control group, 2.5 units of botulinum toxin will be injected bilaterally at Yonsei Point. An insulin needle will be used for injecting the botox.

Procedure: Injection of cross linked hyaluronic acid filler

Group II will receive cross linked hyaluronic acid filler injection

EXPERIMENTAL

Lidocaine 5% ointment will be applied to the intended injection site for 20 mins. In intervention group, a bolus of 0.2 ml of 20% cross linked hyaluronic acid filler will be injected in canine fossa region using a 29G needle preceeded by aspiration for 10 seconds ensuring no blood vessel will be involved.

Procedure: Injection of cross linked hyaluronic acid filler

Interventions

Injection of cross linked hyaluronic acid filler PROCEDURE

Injection of cross linked hyaluronic acid filler

Group I will receive botulinum toxin type A injection.; Group II will receive cross linked hyaluronic acid filler injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with excessive gingival display ranging from 3-8mm due to hypermobile lip.
• Age ranges from 18 years or above.

You may not qualify if:

• Excessive gingival display due to other etiological factors.
• Patients allergic to botox or hyaluronic acid fillers.
• Patients with any medical condition that contraindicates botox or hyaluronic acid filler injection.
• Patients previously injected with permanent fillers.
• Pregnancy.
• Breastfeeding females.
• Patients with active inflammatory or infectious disease at intended site of injection.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

CairoU

Cairo, 00200, Egypt

Location

Cairo University

Giza, 12613, Egypt

Location

Central Study Contacts

Raghda Hussein

CONTACT

01122642622; raghda.metwaly@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters Candidate

Model Details: Lidocaine 5% ointment will be applied to the intended injection site for 20 mins. In control group, 2.5 units of botulinum toxin will be injected bilaterally at Yonsei Point. An insulin needle will be used for injecting the botox. In intervention group, a bolus of 0.2 ml of 20% cross linked hyaluronic acid filler will be injected in canine fossa region using a 29G needle preceeded by aspiration for 10 seconds ensuring no blood vessel will be involved. The product will be infiltrated slowly keeping an angle of 90 degrees in relation to the bone.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 30, 2025
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)