NCT06764654

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

January 2, 2025

Last Update Submit

July 3, 2025

Conditions

Dental ImplantBone Resorption

Keywords

guided suergerydental implantpartial edentulous

Outcome Measures

Primary Outcomes (1)

  • Three-dimensional implant position deviations (measured by intraoral scan and planning software)

    Three-dimensional deviations between the planned implant position and the actual postoperative implant position will be assessed. The deviations will be measured using an intraoral scanner (Medit i700®) and planning software (BlueSky Plan®). Units of measure: horizontal and vertical linear deviation (in millimeters), global deviation (in millimeters), and angular deviation (in degrees), evaluated at both implant entry and apex points.

    From enrollment to the end of surgery

Secondary Outcomes (1)

  • Three-dimensional implant position deviations (measured by CBCT and planning software)

    From enrollment to the end of surgery

Study Arms (2)

Tooth supported guide

ACTIVE COMPARATOR

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

Procedure: Dental implant placement

Bone and tooth supported guide

EXPERIMENTAL

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

Procedure: Dental implant placement

Interventions

Dental implant placementPROCEDURE

Placement of two dental implants in the jaw.

Bone and tooth supported guideTooth supported guide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clínica Dental Esteve

Alicante, Alicante, 03001, Spain

RECRUITING

Clínica Dental Sánchez Nicolás

Cabezo de Torres, Murcia, 30110, Spain

RECRUITING

Related Publications (8)

  • 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: 32151043BACKGROUND

  • 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: 38112164BACKGROUND

  • 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: 34218450BACKGROUND

  • 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: 37875645BACKGROUND

  • 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: 29608793BACKGROUND

  • 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: 34006060BACKGROUND

  • 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: 27062555BACKGROUND

  • 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: 28632253BACKGROUND

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Central Study Contacts

Guillem Esteve-Pardo, PhD

CONTACT

+34 965215755guillem@clinicaesteve.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 8, 2025

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

July 9, 2025

Record last verified: 2025-07

Locations

ES(2)