Management of Excess Gingival Display Using Tunnel Technique With 3D Designed PEEK Shell: A Case Series
- 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PEEK shell in the anterior maxilla inserted by tunnel technique tunnel technique with a 3D printed PEEK shell to fill the skeletal subnasal depression 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
- Primary Outcome Measures
Name Time Method Gingival display Day 0 - Month 3 - Month 6 measured using a periodontal probe in millimeters
- Secondary Outcome Measures
Name Time Method Post operative pain Day 7 Measured by the visual analogue scale ( 0 no pain, 10 worst pain)
profile angle Day 0 - Month 6 lateral cephalometric xray
lip translation Day 0 - Month 3 - Month 6 measured using a periodontal probe in millimeters
blinded esthetic assessment Month 3- Month 6 measured by a binary scale (yes or no)
patient satisfaction Day 7 measured by a binary Questionnaire ( yes or no)
lip length Day 0 - Month 3 - Month 6 measured using a periodontal probe in millimeters
Trial Locations
- Locations (1)
Farah Mamdouh
🇪🇬Cairo, Egypt