NCT06910007

Brief Summary

This study will be conducted to investigate the accuracy of Blue sky plan bio , exoplan ,and real guide advanced treatment planning software required for static computer guided surgery designing and manufacturing.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Apr 2025

Status
not yet 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 Progress65%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

March 22, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

April 20, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2026

Expected
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

March 22, 2025

Last Update Submit

April 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • deviation between planned and actual implant position when using different planning software

    measurement will be done by superimposition two CBCTs showing the pre-operation ( planned) and post operation implant position which will reveal the deviation in millimeter in regards to entry point ,apical ,and angular deviation of dental implant using specified tool within the planning software

    14 days

Study Arms (3)

blue sky plan group

ACTIVE COMPARATOR

surgical guide will be fabricated using Blue sky plan computer software

Procedure: dental implant will be inserted using surgical guideProcedure: dental implant

exoplan group

ACTIVE COMPARATOR

surgical guide will be fabricated using Exoplan computer software

Procedure: dental implant will be inserted using surgical guideProcedure: dental implant

Real guide group

ACTIVE COMPARATOR

surgical guide will be fabricated using Real guide computer software

Procedure: dental implant will be inserted using surgical guideProcedure: dental implant

Interventions

dental implant will be inserted using blue sky plan computer software

Real guide groupblue sky plan groupexoplan group

surgical guide will be fabricated using exoplan computer software

Real guide groupblue sky plan groupexoplan group

Eligibility Criteria

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

You may qualify if:

  • partially edentulous adults with at least three teeth remaining.
  • an expected sufficient bone volume to perform implant insertion with at least a 3.5mm Cybermed dental implant without simultaneous bone augmentation.
  • extractions performed at least 3 months earlier.
  • potential earlier sinus grafting was performed at least 6 months prior to implant placement.
  • Patients with absence of any periodontal problems in the adjacent teeth.
  • stable medical condition to undergo implant surgery (ASA 1 or 2).

You may not qualify if:

  • Physical or psychological disorders generally prohibiting implant therapy. After initial screening.
  • Patients with a history of bruxism
  • Patients with over eruption of the opposing tooth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student in oral and maxillofacial surgery

Study Record Dates

First Submitted

March 22, 2025

First Posted

April 4, 2025

Study Start

April 20, 2025

Primary Completion (Estimated)

November 28, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share