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Completed

NCT Number: NCT06991699

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

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

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Gingival display

    Time frame: up to 9 months

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

Secondary outcomes

  1. Patient satisfaction

    Time frame: up to 9 months

    evaluated using a 10-point visual analogue scale (VAS; 0 = not satisfied, 10 = highly satisfied)

  2. Incidence of Postoperative Complications

    Time frame: up to 9 months

Sponsors and collaborators

Lead sponsor

taher helmy ismail metwaly

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 28, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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