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NCT Number: NCT06017791

Management of Excess Gingival Display Using Tunnel Technique With 3D Designed PEEK Shell: A Case Series

The aim of the current study is to evaluate the use of a PEEK shell placed in the anterior maxilla placed by tunnel technique in decreasing the gingival display

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Key information

Conditions

Excessive Gingival Display

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Farah Mamdouh

Cairo, 11835, Egypt

About this study

While lip repositioning has been established as a treatment modality to address excess gum display (EGD) , an often overlooked contributing factor is the lack of lip support. This is often caused by the architecture of the maxilla at the subnasal area. Maxillary overgrowth may give rise to a subnasal skeletal depression producing decreased lip support and marked upper lip retraction during a smile.

Restricting muscle pull by lip repositioning surgery as a treatment option limits muscle movement, however it does not address lip support. In 2018 an alternative intervention was later proposed in a case report study . The technique involves raising a full thickness flap and applying PMMA (polymethyl methacrylate) cement to fill the subnasal depression and limit the upper lip movement. Since its introduction, a limited number of studies have attempted to investigate the technique, however there are not enough studies to support the outcome or the stability of the technique. The aim of the current study is to evaluate the use of a tunnel technique with a 3D printed PEEK (Polyetherether ketone) shell to fill the skeletal subnasal depression

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with excess gingival display 2.5mm or more
  • Patients with an exaggerated subnasal concavity
  • Decreased/normal value of SNA ( angle between sella, nation, A point) in cephalometric measurement
  • Decreased/normal cephalometric measurement of A to N-perpendicular (perpendicular from N on FHP)
  • Decreased/normal value in cephalometric measurement of the convexity at point A (linear measurement from point A to facial plane)
  • Decreased/normal value of Ricketts Esthetic plane in cephalometric measurement
  • Decreased/normal value of Holdaway H-angle in cephalometric measurement
  • Nasolabial angle range from 100° to 120°
  • Patients 20-60 years old
  • Medically free
  • Compliant patient that agrees to the follow up period

Exclusion criteria

  • Pregnant and lactating females
  • Smokers
  • Diabetics
  • Patients with parafunctional habits that may affect the outcome of the procedure
  • Medically compromised patients

Treatment and study plan

tunnel technique with a 3D printed PEEK shell to fill the skeletal subnasal depression

Other

The area will be anesthetized using infiltration technique with 1.5ml of anesthetic solution containing Articaine Hydrochloride 68 mg/1.7 ml with Adrenaline 0.017 mg/1.7 ml

Two bilateral full thickness vertical incisions will be created using a #15 blade. One on each side of the frenum

A subperiosteal tunnel connecting the two vertical incisions will be created using a periosteal elevator/tunneling knife until the complete communication between the two ends is established

The custom made PEEK framework will be inserted from the incision on one side and eased through until it sits in the subnasal concavity.

Once fitted in place the shell will be fixed in place using two mini screws bilaterally, one on each side.

The two vertical incisions will be closed by interrupted sutures 6-0 Polyglycolic acid suture material

Primary outcomes

  1. Gingival display

    Time frame: Day 0 - Month 3 - Month 6

    measured using a periodontal probe in millimeters

Secondary outcomes

  1. lip translation

    Time frame: Day 0 - Month 3 - Month 6

    measured using a periodontal probe in millimeters

  2. profile angle

    Time frame: Day 0 - Month 6

    lateral cephalometric xray

  3. lip length

    Time frame: Day 0 - Month 3 - Month 6

    measured using a periodontal probe in millimeters

  4. patient satisfaction

    Time frame: Day 7

    measured by a binary Questionnaire ( yes or no)

  5. Post operative pain

    Time frame: Day 7

    Measured by the visual analogue scale ( 0 no pain, 10 worst pain)

  6. blinded esthetic assessment

    Time frame: Month 3- Month 6

    measured by a binary scale (yes or no)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2023
Registry last updated
Mar 23, 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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