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Completed

NCT Number: NCT06983262

Comparative Evaluation of Milled Polyether Ether Ketone (PEEK) Stent Placement and Lip Repositioning Surgery on the Treatment of Gummy Smile

The objective of this study is to compare between a Polyether ether ketone (PEEK) stent - and standard lip repositioning technique for management of gummy smile

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Key information

Conditions

Gummy Smile

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.

Lip repositioning surgery

Procedure

Profound anaesthesia will be achieved. A marking pencil§ will be used to outline the apical, coronal, and lateral boundaries of the elliptical incision. The coronal boundary will be at the mucogingival junction and will be used as a reference point to mark the apical boundary at two times the amount of gingival display. The coronal and apical incisions will be parallel to each other, and the apical incision gradually angled downward to meet the coronal incision. A partial thickness dissection will be made. The epithelium will be excised, exposing the underlying connective tissue. The mucosal flap will be advanced and sutured at the mucogingival junction.

Primary outcomes

  1. Postoperative pain assessment

    Time frame: up to one week

    Postoperative pain will be evaluated at first and seventh day using numeric rating scale (NRS). Patient will rate his pain on a scale from 0 to 10, with 0 indicating no pain and 10 reflecting the worst possible pain.

    • 0 = no pain
    • 1-3 = mild pain
    • 4-6 = moderate pain
    • 7-10 = severe pain

  2. Facial Edema (Swelling)

    Time frame: up to one week

    Postoperative edema was measured with a flexible tape measure by calculating the distance between several facial landmarks and comparing them to preoperative values.

  3. Healing Quality

    Time frame: up to 3 weeks

    Measured according to Landry's Healing Index which records healing on basis of tissue colour, bleeding, ulceration, granulation tissue and epithelisation.

    Scores range from 1 (Very poor) to 5 (excellent)

  4. Gingival display

    Time frame: up to 9 months

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

Sponsors and collaborators

Lead sponsor

taher helmy ismail metwaly

Other

Registry information

Official study title

Comparative Evaluation of Milled Polyether Ether Ketone (PEEK) Stent Placement and Lip Repositioning Surgery on the Treatment of Gummy Smile (A Randomized Controlled Clinical Trial)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 21, 2025
Registry last updated
Jul 13, 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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