Recruiting NCT06764654
Randomized Clinical Study Comparing Two Guided Surgery Techniques for Free-end Implant Placement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dental implant placement.
- Who it may be relevant to
- Registry conditions: Dental Implant, Bone Resorption. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Clinical Study Comparing Two Guided Surgery Techniques for Free-end Implant Placement: A Multicenter Study
Overview
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.
Interventions
- Procedure Dental implant placement
Placement of two dental implants in the jaw.
Primary outcome measures
- Three-dimensional implant position deviations (measured by intraoral scan and planning software) [Time frame: From enrollment to the end of surgery]
Secondary outcome measures (1)
- Three-dimensional implant position deviations (measured by CBCT and planning software) [Time frame: From enrollment to the end of surgery]
Eligibility criteria
Inclusion criteria
- Patients who present to one of the two participating clinics with a posterior edentulous area starting from the second premolar.
- Patients in whom the placement of dental implants is not contraindicated.
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 women undergoing contraceptive treatment.
- Signs of infection in the surgical area.
- Need for unconventional surgical procedures (e.g., split crest, vertical regeneration, block graft).
- Lack of patient cooperation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 2 centers
- Clínica Dental Esteve — Alicante
- Clínica Dental Sánchez Nicolás — Cabezo de Torres
Publications
- 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. PMID 32151043
- 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. PMID 38112164
- 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. PMID 34218450
- 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. PMID 37875645
- 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. PMID 29608793
- 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. PMID 34006060
- 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. PMID 27062555
- 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. PMID 28632253
Identifiers
NCT: NCT06764654 · GUIDED