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

Not Applicable
Recruiting
Conditions
Excessive Gingival Display
Interventions
Other: tunnel technique with a 3D printed PEEK shell to fill the skeletal subnasal depression
Registration Number
NCT06017791
Lead Sponsor
Cairo University
Brief Summary

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

Detailed 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

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
10
Inclusion Criteria
  • Patients with excess gingival display 2.5mm or more
  • Patients with an exaggerated subnasal concavity
  • Decreased/low normal value of SNA ( angle between sella, nation, A point) in cephalometric measurement
  • Decreased/low normal cephalometric measurement of A to N-perpendicular (perpendicular from N on FHP)
  • Decreased/low normal value in cephalometric measurement of the convexity at point A (linear measurement from point A to facial plane)
  • Decreased/low normal value of Ricketts Esthetic plane in cephalometric measurement
  • Decreased/low 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
Read More
Exclusion Criteria
  • Patients with flared upper incisors in lateral cephalometric X-ray
  • Pregnant and lactating females
  • Smokers
  • Diabetics
  • Patients with parafunctional habits that may affect the outcome of the procedure
  • Medically compromised patients
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
PEEK shell in the anterior maxilla inserted by tunnel techniquetunnel technique with a 3D printed PEEK shell to fill the skeletal subnasal depressionuse 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
Primary Outcome Measures
NameTimeMethod
Gingival displayDay 0 - Month 3 - Month 6

measured using a periodontal probe in millimeters

Secondary Outcome Measures
NameTimeMethod
Post operative painDay 7

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

profile angleDay 0 - Month 6

lateral cephalometric xray

lip translationDay 0 - Month 3 - Month 6

measured using a periodontal probe in millimeters

blinded esthetic assessmentMonth 3- Month 6

measured by a binary scale (yes or no)

patient satisfactionDay 7

measured by a binary Questionnaire ( yes or no)

lip lengthDay 0 - Month 3 - Month 6

measured using a periodontal probe in millimeters

Trial Locations

Locations (1)

Farah Mamdouh

🇪🇬

Cairo, Egypt

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