Clinical trial NCT06764654: Randomized Clinical Study Comparing Two Guided Surgery Techniques for Free-end Implant Placement
Official title: Randomized Clinical Study Comparing Two Guided Surgery Techniques for Free-end Implant Placement: A Multicenter Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implant
Bone Resorption
Keywords: guided suergery
dental implant
partial edentulous
Lead sponsor: Aula Dental Avanzada
Sponsor class: OTHER
Collaborators: name: Mozo Grau S.A.
First posted: 2025-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized multicenter clinical study that compares two static guided surgery techniques in free-end partial edentulism.

The aim is to compare the accuracy obtained between dento-osseous supported and dento-mucosal supported surgical splints to place dental implants in posterior osseous ridges.


Eligibility criteria: Inclusion Criteria: All patients who come to one of the two clinics mentioned above with a posterior edentulous area from the second premolar onwards and in whom the placement of dental implants is not contraindicated.

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Exclusion Criteria: Patients with hypersensitivities or allergies that contraindicate the intervention, presence of orofacial neurological symptoms, patients treated with bisphosphonates, pregnant or breastfeeding women or with contraceptive treatment, signs of infection in the area to be operated, unconventional surgical requirements, or lack of collaboration would be excluded.

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Primary outcomes:
measure: Three-dimensional deviations
timeFrame: From enrollment to the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cabezo De Torres
country: Spain
facility: Clínica Dental Sánchez Nicolás
state: Murcia
city: Alicante
country: Spain
facility: Clínica Dental Esteve
Study officials:
References:
citation: Lin CC, Ishikawa M, Maida T, Cheng HC, Ou KL, Nezu T, Endo K. Stereolithographic Surgical Guide with a Combination of Tooth and Bone Support: Accuracy of Guided Implant Surgery in Distal Extension Situation. J Clin Med. 2020 Mar 5;9(3):709. doi: 10.3390/jcm9030709.
citation: Liu R, Xia R, Zhang L, Gan X, Li C, Liu Q, Chen Z, Chen Z. The influence of guide stabilizers and their application sequences on trueness and precision of surgical guides in free end situations: An in vitro analysis. Clin Oral Implants Res. 2024 Mar;35(3):294-304. doi: 10.1111/clr.14226. Epub 2023 Dec 19.
citation: Kessler A, Le V, Folwaczny M. Influence of the tooth position, guided sleeve height, supporting length, manufacturing methods, and resin E-modulus on the in vitro accuracy of surgical implant guides in a free-end situation. Clin Oral Implants Res. 2021 Sep;32(9):1097-1104. doi: 10.1111/clr.13804. Epub 2021 Jul 17.
citation: Shi Y, Wang J, Ma C, Shen J, Dong X, Lin D. A systematic review of the accuracy of digital surgical guides for dental implantation. Int J Implant Dent. 2023 Oct 25;9(1):38. doi: 10.1186/s40729-023-00507-w.
citation: Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.
citation: Cho JY, Kim SB, Ryu J. The accuracy of a partially guided system using an in-office 3D-printed surgical guide for implant placement. Int J Comput Dent. 2021 Feb 26;24(1):19-27.
citation: Raico Gallardo YN, da Silva-Olivio IRT, Mukai E, Morimoto S, Sesma N, Cordaro L. Accuracy comparison of guided surgery for dental implants according to the tissue of support: a systematic review and meta-analysis. Clin Oral Implants Res. 2017 May;28(5):602-612. doi: 10.1111/clr.12841. Epub 2016 Apr 8.
citation: Bover-Ramos F, Vina-Almunia J, Cervera-Ballester J, Penarrocha-Diago M, Garcia-Mira B. Accuracy of Implant Placement with Computer-Guided Surgery: A Systematic Review and Meta-Analysis Comparing Cadaver, Clinical, and In Vitro Studies. Int J Oral Maxillofac Implants. 2018 January/February;33(1):101-115. doi: 10.11607/jomi.5556. Epub 2017 Jun 20.