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

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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06983262
Enrollment
16
Registered
2025-05-21
Start date
2024-02-14
Completion date
2025-04-10
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gummy Smile

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

Interventions

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.

PROCEDURELip repositioning surgery

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.

Sponsors

taher helmy ismail metwaly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain assessmentup to one weekPostoperative 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
Facial Edema (Swelling)up to one weekPostoperative edema was measured with a flexible tape measure by calculating the distance between several facial landmarks and comparing them to preoperative values.
Healing Qualityup to 3 weeksMeasured 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)
Gingival displayup to 9 monthsDistance from gingival margin to lower border of upper lip vermilion border will be measured

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026