A Novel Digitally Driven Approach for Gummy Smile Solution Using Milled Sub-nasal Stent

NCT06991699 | Completed

• 1 other identifier: 3/1-2024
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the effectiveness of a Polyether ether ketone (PEEK) stent for management of gummy smile.

Conditions

Gummy Smile

Outcome Measures

Primary Outcomes (1)

• Gingival display

  Distance from gingival margin to lower border of upper lip vermilion border will be measured

  up to 9 months

Secondary Outcomes (2)

• Patient satisfaction

  up to 9 months

• Incidence of Postoperative Complications

  up to 9 months

Study Arms (1)

Milled PEEK Stent

EXPERIMENTAL

Other: Milled PEEK Stent

Interventions

Milled PEEK Stent OTHER

A CBCT will be performed to assess the anatomy of the subnasal area and plan the position, size, shape and thickness of the PEEK Stent. These data will be transferred to a 3D planning software to generate a digital model. Eventually, the PEEK stents will be milled in a milling machine and sterilized in ethylene oxide before the surgery. Local anesthesia will be administered into the vestibular mucosa along the extension of the anterior maxilla. VISTA technique begins with a vestibular access incision in the midline frenum and 2 bilateral incisions at premolar area. A periosteal elevator will be introduced through the incision and inserted between the bone and periosteum to elevate the tissue, creating a subperiosteal tunnel, extending distally based on the dynamic of the smile. The PEEK stent will be in one piece. They will be placed onto the bone and stabilized with 2 bone graft screw for each side. The midline incision and the lateral incisions will be sutured primarily.

Milled PEEK Stent

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy individuals
• Chiefs complain gummy smile
• Gummy smile due to short hypermobile upper lip
• Gingival Display not more than 5 mm

You may not qualify if:

• Pregnancy
• Lactation
• History of smoking more than 10 cigarettes per day
• Systemic conditions or intake of medications that could affect soft and hard tissue healing
• Use of orthodontic appliances
• Gingival display above 5mm

Sponsors & Collaborators

• taher helmy ismail metwaly: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc. Candidate of Periodontology

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: February 8, 2024
• Primary Completion: April 8, 2025
• Study Completion: April 8, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

EG (1)