Clinical trial NCT06017791: Management of Excess Gingival Display Using Tunnel Technique With 3D Designed PEEK Shell: A Case Series
Official title: Management of Excess Gingival Display Using Tunnel Technique With 3D Designed PEEK Shell: A Case Series
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Excessive Gingival Display
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Gingival display
timeFrame: Day 0 - Month 3 - Month 6
Secondary outcomes:
measure: lip translation
timeFrame: Day 0 - Month 3 - Month 6
measure: profile angle
timeFrame: Day 0 - Month 6
measure: lip length
timeFrame: Day 0 - Month 3 - Month 6
measure: patient satisfaction
timeFrame: Day 7
measure: Post operative pain
timeFrame: Day 7
measure: blinded esthetic assessment
timeFrame: Month 3- Month 6
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Farah Mamdouh
Study officials:
References:
citation: Brizuela M, Ines D. Excessive Gingival Display. 2023 Mar 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470437/
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citation: Labial repositioning using polymethylmethracylate (PMMA)-based cement for esthetic smile rehabilitation-A case report Toni Arcuri a, Maykson Feitosa Pereira da Costa b, Iury Machado Ribeiroa, Byron Daia Barreto Júnior b, João Paulo Lyra eSilvac,∗ a Department of Dentistry, Paulista University, UNIP, Brasília, Brazil b Private Office in Brasilia, Brazil c Department of Dentistry, Universitary Center Euro Americano, UNIEURO, Brasília, Brazil
citation: ASSENZA, B. & Carinci, Francesco & CRISTINZI, A. & Sinjari, Bruna & Murmura, Giovanna & Scarano, Antonio. (2011). A COSMETIC TECHNIQUE CALLED LIP REPOSITIONING IN PATIENT OF EXCESSIVE GINGIVAL DISPLAY. European Journal of Inflammation. 9. 115-119.
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