NCT07112664

Brief Summary

The goal of this clinical trial is to learn how accurate fully guided dental implant placement is when performed by experienced versus novice clinicians. It will also study how different types of surgical guides affect the accuracy of implant placement. The main questions it aims to answer are: Does the clinician's level of experience affect how closely the dental implant matches the planned position? Does the type of surgical guide (tooth-supported or mucosa-supported) influence implant placement accuracy? Researchers will compare the implant accuracy across six groups based on clinician experience and guide type. Participants will: Undergo a fully guided dental implant procedure using a 3D-printed surgical guide Be treated by either an experienced or a novice clinician Receive follow-up scans to measure how accurately the implant was placed compared to the digital plan

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

May 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

August 2, 2025

Last Update Submit

December 21, 2025

Conditions

Keywords

Dental Implants, Fully Guided Surgery, Guided Implant Placement, Surgical Guide Accuracy, Implant Deviation, Dental Implantology, Digital Implant Planning

Outcome Measures

Primary Outcomes (1)

  • Angular Deviation

    The angular deviation is defined as the angle (in degrees) between the long axis of the virtually planned implant and the long axis of the actual placed implant. It reflects the angular accuracy of guided implant placement.

    Immediately postoperative (within 1 day after implant placement)

Secondary Outcomes (3)

  • Coronal Global Deviation (CGD)

    Immediately postoperative

  • Apical Global Deviation (AGD)

    Immediately postoperative

  • Depth Deviation

    Immediately postoperative

Study Arms (6)

Experienced Clinician - Bilateral Tooth-Supported Guide

EXPERIMENTAL

Experienced Clinician - Bilateral Tooth-Supported Guide Participants receive fully guided dental implant placement using a bilateral tooth-supported surgical guide. The procedure is performed by an experienced clinician with over 500 guided implant placements.

Device: Fully Guided Dental Implant Placement Using Surgical Guide

Experienced Clinician - Unilateral Tooth-Supported Guide

EXPERIMENTAL

Experienced Clinician - Unilateral Tooth-Supported Guide Participants receive fully guided dental implant placement using a unilateral tooth-supported surgical guide. The procedure is conducted by an experienced clinician.

Device: Fully Guided Dental Implant Placement Using Surgical Guide

Experienced Clinician - Mucosa-Supported Guide

EXPERIMENTAL

Participants receive fully guided dental implant placement using a mucosa-supported surgical guide. The procedure is performed by an experienced clinician with extensive experience in guided surgery.

Device: Fully Guided Dental Implant Placement Using Surgical Guide

Novice Clinician - Bilateral Tooth-Supported Guide

EXPERIMENTAL

Participants receive fully guided dental implant placement using a bilateral tooth-supported surgical guide. The procedure is performed by a novice clinician with fewer than 20 guided implant cases and at least one year of general implant experience.

Device: Fully Guided Dental Implant Placement Using Surgical Guide

Novice Clinician - Unilateral Tooth-Supported Guide

EXPERIMENTAL

Participants receive fully guided dental implant placement using a unilateral tooth-supported surgical guide, performed by a novice clinician.

Device: Fully Guided Dental Implant Placement Using Surgical Guide

Novice Clinician - Mucosa-Supported Guide

EXPERIMENTAL

Participants receive fully guided dental implant placement using a mucosa-supported surgical guide. The procedure is carried out by a novice clinician under standard protocol.

Device: Fully Guided Dental Implant Placement Using Surgical Guide

Interventions

All participants will undergo fully guided dental implant placement using a 3D-printed surgical guide (tooth-supported or mucosa-supported). The surgical guide is designed and fabricated based on preoperative CBCT and intraoral scan data. Implant site preparation and fixture insertion are performed entirely through the guide using manufacturer-specific guided surgery kits.

Experienced Clinician - Bilateral Tooth-Supported GuideExperienced Clinician - Mucosa-Supported GuideExperienced Clinician - Unilateral Tooth-Supported GuideNovice Clinician - Bilateral Tooth-Supported GuideNovice Clinician - Mucosa-Supported GuideNovice Clinician - Unilateral Tooth-Supported Guide

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older
  • Clinical situation suitable for dental implant placement as judged by the examining physician or principal investigator
  • Adequate soft and hard tissue conditions for implant placement
  • Adequate occlusion in the implant area
  • Sufficient bone volume to place the implant without bone augmentation (i.e., at least 2 mm of bone circumferentially around the implant site based on preoperative CBCT)

You may not qualify if:

  • Major systemic diseases (e.g., uncontrolled diabetes, immunosuppressive conditions)
  • Untreated or uncontrolled dental caries
  • Active periodontal disease
  • Requirement for bone augmentation or sinus lift in the implant area
  • Current pregnancy
  • Current smoker (defined as \>10 cigarettes per day)
  • Noncompliance or inability to follow study protocols
  • Known allergies to materials used in the implant system or medications administered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71111, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Oral Medicine and Periodontology , Assiut University

Study Record Dates

First Submitted

August 2, 2025

First Posted

August 8, 2025

Study Start

May 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 15, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations