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

NCT06983262 | Completed

• 1 other identifier: 1/3-2024
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gummy Smile

Outcome Measures

Primary Outcomes (4)

• Postoperative pain assessment

  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

  up to one week

• Facial Edema (Swelling)

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

  up to one week

• Healing Quality

  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)

  up to 3 weeks

• Gingival display

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

  up to 6 months

Study Arms (2)

VISTA and Milled PEEK stent

EXPERIMENTAL

Other: Milled PEEK Stent

Lip repositioning surgery

ACTIVE COMPARATOR

Procedure: Lip repositioning surgery

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.

VISTA and Milled PEEK stent

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.

Lip repositioning surgery

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc. Candidate in Periodontology

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: May 21, 2025
• Study Start: February 14, 2024
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

EG (1)