Management of Excess Gingival Display Using Tunnel Technique With 3D Designed PEEK Shell: A Case Series
NCT ID: NCT06017791
Last Updated: 2024-09-04
Study Results
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Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2023-11-08
2026-02-28
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PEEK shell in the anterior maxilla inserted by tunnel technique
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
tunnel technique with a 3D printed PEEK shell to fill the skeletal subnasal depression
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
Interventions
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tunnel technique with a 3D printed PEEK shell to fill the skeletal subnasal depression
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Smokers
* Diabetics
* Patients with parafunctional habits that may affect the outcome of the procedure
* Medically compromised patients
20 Years
60 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Farah Mamdouh Abdelfatah Mohamed Sheeba
Principal investigator
Locations
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Farah Mamdouh
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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/
El-Bokle, Dalia & Ghany, Amany. (2022). A sequential diagnostic scheme for excessive gingival display (Gummy Smile). AJO-DO Clinical Companion. 2. 10.1016/j.xaor.2022.05.003
Impellizzeri A, Palmigiani R, Horodynski M, D'alfonso T, Polimeni A, De Stefano A, Galluccio G. Is There a Correlation between Gingival Display and Incisal Inclination in a Gummy Smile? Study on Cephalometric Parameters. Healthcare (Basel). 2023 Jan 25;11(3):344. doi: 10.3390/healthcare11030344.
Monaco A, Streni O, Marci MC, Marzo G, Gatto R, Giannoni M. Gummy smile: clinical parameters useful for diagnosis and therapeutical approach. J Clin Pediatr Dent. 2004 Fall;29(1):19-25. doi: 10.17796/jcpd.29.1.y01l3r4m06q3k2x0.
Toth, J. M. (2012). Biocompatibility of Polyaryletheretherketone Polymers. PEEK Biomaterials Handbook, 81-92. doi:10.1016/b978-1-4377-4463-7.10007-7
Freitas de Andrade P, Meza-Mauricio J, Kern R, Faveri M. Labial Repositioning Using Print Manufactured Polymethylmethacrylate- (PMMA-) Based Cement for Gummy Smile. Case Rep Dent. 2021 Dec 21;2021:7607522. doi: 10.1155/2021/7607522. eCollection 2021.
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
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.
Dym H, Pierre R 2nd. Diagnosis and Treatment Approaches to a "Gummy Smile". Dent Clin North Am. 2020 Apr;64(2):341-349. doi: 10.1016/j.cden.2019.12.003. Epub 2020 Jan 24.
Saleem R, Kukreja BJ, Goyal M, Kumar M. Treating short upper lip with "Unified lip repositioning" technique: Two case reports. J Indian Soc Periodontol. 2022 Jan-Feb;26(1):89-93. doi: 10.4103/jisp.jisp_90_20. Epub 2022 Jan 1.
Other Identifiers
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21623
Identifier Type: -
Identifier Source: org_study_id
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