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

Cairo University (CU) logo

Cairo University (CU)

Status

Enrolling

Conditions

Excessive Gingival Display

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06017791
21623 (Other Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment

10 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

PEEK shell in the anterior maxilla inserted by tunnel technique
Experimental group
Description:
use of a minimally invasive tunnel technique to fill the skeletal subnasal depression with a PEEK shell in patients with an exaggerated subnasal depression associated with lack of lip support and excessive lip translation
Treatment:
Other: tunnel technique with a 3D printed PEEK shell to fill the skeletal subnasal depression

Trial contacts and locations

1

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Central trial contact

Farah Sheeba, BDS

Data sourced from clinicaltrials.gov

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