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

NCT06991699 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-02-27

No results posted yet for this study

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

Interventions

OTHER

Milled PEEK Stent

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.

Sponsors & Collaborators

  • taher helmy ismail metwaly

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-08
Primary Completion
2025-04-08
Completion
2025-04-08

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06991699 on ClinicalTrials.gov