NCT06255522

Brief Summary

The importance of the stability of hard and soft tissues has been shown to be of paramount importance for long-term implant success. To reach optimal functional and aesthetic outcomes, implant placement must be planned accordingly to prosthetic needs and design. Prosthetically driven implant placement is based on a diagnostic prosthetic set-up that is followed by precise implant planification and placement using CBCT and intraoral scanning. The aim of this research is to evaluate how the clinical and anatomical factors can influence the 3D position of guided surgery.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

November 22, 2023

Last Update Submit

May 8, 2024

Conditions

Edentulous Mouth

Keywords

Fully guided implant placementAccuracy

Outcome Measures

Primary Outcomes (1)

  • Accuracy of fully guided implant placement

    Both CBCT will be aligned (pre-op scan and post-op scan) to make calculations by a single evaluator (AB) included the following: (1) angle: angle deviation measured in degrees; (2) base: deviation at implant shoulder in millimeters; (3) tip: deviation at implant apex in millimeters; (4) 3D offset: global deviation in 3D directions in millimeters; (5) mesiodistal deviation in millimeters: (+) deviated to the distal direction and (-) deviated to the mesial direction; (6) buccolingual deviation in millimeters: direction: (+) deviated to lingual direction and (-) deviated to buccal direction; and (7) apicocoronally deviation in millimeters: direction: ( +) deviated in the apical direction. and (-) deviated in the coronal direction.

    Baseline

Study Arms (1)

Fully guided implant placement

EXPERIMENTAL

Through guided surgery implant placement will be performed in maxilla or mandibula in a one stage surgery. The final position will be compare with the initial digital implant planning.

Procedure: Fully guided implant placement

Interventions

Fully guided implant placementPROCEDURE

Through guided surgery, previously planned and designed based on CBCT study and CAD/CAM scanning, implant placement of Conelog Progressive line implants (Biohorizons Camlog, Iberia) will be performed in maxilla or mandibula in a one stage surgery. Postoperative CBCT in ECO mode (35μSv) will be taken after the implant placement to assess the final position and comparing with the initial digital planning.

Fully guided implant placement

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between 25 to 60 years old.
  • Periodontally stable patients. Adequate oral hygiene with less than 15% Full Mouth Plaque Score (FMPS).
  • Patients who need dental implant treatment without simultaneous regeneration.
  • Ability to follow instructions and availability to attend for regular compliance during the entire study.
  • With presence of partial edentulism (at least 6 remaining teeth distributed in the dental arch to support the guide).

You may not qualify if:

  • Active infections
  • Untreated periodontal disease
  • Heavy smokers (\>10 cigarettes per day)
  • Drug / Alcohol dependency
  • Medical condition contraindicating implants dependency
  • Patients under bisphosphonate therapy
  • Limited mouth opening
  • Edentulous patients or with les than 6 teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Blasi Barcelona

Barcelona, 08021, Spain

RECRUITING

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Central Study Contacts

Marta Valles, DDS, MSc, PhD

CONTACT

+34619747903mvalles@uic.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 22, 2023

First Posted

February 13, 2024

Study Start

March 1, 2024

Primary Completion

October 31, 2024

Study Completion

November 30, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)