Randomized Clinical Study Comparing Two Guided Surgery Techniques for Free-end Implant Placement

NCT ID: NCT06764654

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Implant Bone Resorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
The operator does not know what type of surgical splint to use until the very moment of the operation, just after the anesthesia is applied.

Study Groups

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Tooth supported guide

Patients who will receive implant placement using a tooth supported surgical guide.

Group Type ACTIVE_COMPARATOR

Dental implant placement

Intervention Type PROCEDURE

Placement of two dental implants in the jaw.

Bone and tooth supported guide

Patients who will receive implant placement using a bone and tooth supported surgical guide.

Group Type EXPERIMENTAL

Dental implant placement

Intervention Type PROCEDURE

Placement of two dental implants in the jaw.

Interventions

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Dental implant placement

Placement of two dental implants in the jaw.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mozo Grau Ticare

UNKNOWN

Sponsor Role collaborator

Aula Dental Avanzada

OTHER

Sponsor Role lead

Responsible Party

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Jose Antonio Sánchez-Nicolás

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clínica Dental Esteve

Alicante, Alicante, Spain

Site Status RECRUITING

Clínica Dental Sánchez Nicolás

Cabezo de Torres, Murcia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Guillem Esteve-Pardo, PhD

Role: CONTACT

+34 965215755

Facility Contacts

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Guillem Esteve-Pardo, PhD

Role: primary

+34 965215755

Jose Antonio Sánchez-Nicolás, DDS

Role: primary

+34 968907578

References

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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.

Reference Type BACKGROUND
PMID: 32151043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38112164 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34218450 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37875645 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29608793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34006060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27062555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28632253 (View on PubMed)

Other Identifiers

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GUIDED

Identifier Type: -

Identifier Source: org_study_id

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