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

Excessive Gingival Display Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017791
• Other study ID #: 21623
• Status: Recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: Farah Sheeba, BDS
• Phone: 01220700219
• Email: farah.sheeba1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Excessive Gingival Display

Intervention

Other:
• 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 above the maxillary canines in the alveolar mucosa 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

Locations

Country	Name	City	State
Egypt	Farah Mamdouh	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

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.

Brizuela M, Ines D. Excessive Gingival Display. 2023 Mar 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470437/ — View Citation

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. — View Citation

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

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. — View Citation

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. — View 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

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. — View Citation

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. — View Citation

Toth, J. M. (2012). Biocompatibility of Polyaryletheretherketone Polymers. PEEK Biomaterials Handbook, 81-92. doi:10.1016/b978-1-4377-4463-7.10007-7

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival display	measured using a periodontal probe in millimeters	Day 0 - Month 3 - Month 6
Secondary	lip translation	measured using a periodontal probe in millimeters	Day 0 - Month 3 - Month 6
Secondary	profile angle	lateral cephalometric xray	Day 0 - Month 6
Secondary	lip length	measured using a periodontal probe in millimeters	Day 0 - Month 3 - Month 6
Secondary	patient satisfaction	measured by a binary Questionnaire ( yes or no)	Day 7
Secondary	Post operative pain	Measured by the visual analogue scale ( 0 no pain, 10 worst pain)	Day 7
Secondary	blinded esthetic assessment	measured by a binary scale (yes or no)	Month 3- Month 6