Fully Versus Partially Guided Implants Placement: Measurement of Accuracy of Implant Position and Passivity of Superstructures.

NCT07174791 | Active Not Recruiting DMC

• 1 other identifier: A03010024RP
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

compare fully versus partially guided all on four implants placement immediately loaded by maxillary and mandibular screw retained overdentures: A radiographic and photogrammetric measurement of accuracy of implant position and passivity of superstructures. The measurements will be done as follows:

1. 1.Photogrammetric scan immediately after implant instalments to measure 3D accuracy of implant position and Passivity of super structure
2. 2.Cone beam X ray to measure the implant marginal bone height changes.
3. 3.Implant marginal soft tissue evaluations including pocket probing depth, plaque and gingival indices. Evaluation will be done immediately, one and two years after loading.

Conditions

Completely Edentulous; Implant Assesment

Keywords

Guided surgery; semi-guided surgery; full arch implants; photogrammetry

Outcome Measures

Primary Outcomes (1)

• accuracy of implant insertion

  accuracy of implant position will be measured immediately after implant insertion by using photogrammetry scan for implants with multi-unit abutments intra-orally and on the model created from the planned implants and fitting surface of surgical guide, superimposition of both scans will be done using geomagic software to determine deviation in implant positions between both scans (Presurgical and post surgical) for both groups and calculated in fractions of millimeters, the value of deviation found in both semi-guided and fully-guided groups will be compared.

  immediately after implant insertion

Secondary Outcomes (2)

• passive fit of final prosthesis

  immediately after final restoration insertion

• Marginal bone loss

  24 months after prosthesis insertion

Study Arms (2)

partially- guided (PG) implant instalment

ACTIVE COMPARATOR

partial guided allow control until the drill before the last one using universal drilling kit and the final osteotomy done with the system specific finishing drill after removal of the surgical guide.

Device: cone beam computed tomography; Device: photogrammetric scan using elite scanner (shining 3d)

fully- guided (FG)implant instalment

ACTIVE COMPARATOR

Fully guided guides allow complete guidance to the drills tell the final one in addition to implants placement through the guide with control to the implant timing

Device: cone beam computed tomography; Device: photogrammetric scan using elite scanner (shining 3d)

Interventions

cone beam computed tomography DEVICE

-Implant marginal bone height changes will be measured by cone beam radiograph after one and two years of loading

fully- guided (FG)implant instalment; partially- guided (PG) implant instalment

photogrammetric scan using elite scanner (shining 3d) DEVICE

implant placement accuracy will be evaluated using photogrammetric scan after implant insertion

fully- guided (FG)implant instalment; partially- guided (PG) implant instalment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely healed residual alveolar ridges
• Angle's class I maxillo-mandibular relationship.
• Sufficient mandibular and maxillary restorative spaces, at least 15mm evaluated by recording a tentative jaw relation.
• Adequate bone height in the premaxilla area, and the anterior mandibular area. - This will be evaluated radiographically

You may not qualify if:

• Systemic disorders affecting bone (such as uncontrolled diabetes mellitus and osteoporosis).
• Local or general contraindication for surgical procedures.
• History of chemotherapy or radiation therapy to the head and neck area.
• Poor neuromuscular co-ordination.
• TMJ dysfunction and parafunctional habits

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Faculty of Dentistry, mansoura, egypt

Al Mansurah, Mansoura, Egypt

Location

MeSH Terms

Interventions

Cone-Beam Computed Tomography

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Tomography, X-Ray; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography

Study Officials

• Mohamed Shady Mohamed Shady, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: According to the virtual 3D planning and surgical guide designing for implant instalment, patients will be randomly divided into two equal treatment groups (4 patients for each) as follows: Group (I): partially- guided (PG) implant instalment Group (II): fully- guided (FG)implant instalment both groups will be subjected to: 1. cone beam computed tomography to evaluate peri-implant alveolar bone loss 2. photogrammetric scan for evaluation of accuracy of implant placement and passivity of final prosthesis

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: September 16, 2025
• Study Start: January 15, 2025
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)