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Fully Guided Dental Implant Placement and Primary Stability

Assessing the Role of 3D-Printed Surgical Guides in Enhancing Dental Implant Placement Precision and Patient Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07149987
Enrollment
30
Registered
2025-09-02
Start date
2025-01-10
Completion date
2025-06-20
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cone Beam Computed Tomography, Dental Implant, Dental Implant Failure, Peri Implantitis

Keywords

3D- implant surgical guide, C-Tech® implants, DICOM file

Brief summary

The precision of dental implant placement is vital for long-term implant success. The surgical guide is designed using advanced 3D imaging techniques allows for a highly accurate simulation of the ideal implant position, angulation, and depth based on the patient's unique anatomy. The aim of the study is to compare implant stability and postoperative pain between guided and freehand surgical implant placement. The research objective is to assess and compare the clinical outcomes of guided surgical implants placement versus conventional freehand implant placement, focusing on primary implant stability, secondary implant stability and postoperative pain. In alignment with this objective, the aim of this study is to compare the clinical outcomes: as implant primary and secondary stability and postoperative pain between guided surgical implant placement and conventional freehand surgical implant placement. Hypothesis of the study This study hypothesized that guided implant surgery will result in superior implant stability outcome and reduced postoperative pain compared to the freehand technique High light of study. The use of advance technology (machines and software programs) to enhance implant survival and reduce surgical complications associated with implant placement. It is worth noting that, a fully guided implant placement provides flapless surgery and the implant positions were virtually planned based on anatomical and prosthetic considerations. The use of Easy Check Implant Stability Measuring System for measuring primary and secondary implant stability.

Detailed description

Background: The precision of dental implant placement is vital for long-term implant success. The surgical guide is designed using advanced 3D imaging techniques allows for a highly accurate simulation of the ideal implant position, angulation, and depth based on the patient's unique anatomy. The aim of the study is to compare implant stability and postoperative pain between guided and freehand surgical implant placement. Methods: randomized controlled clinical study included 30 patients with a total of 30 implants were placed and analyzed. All patients were randomly allocated into two groups: Test Group (Guided Surgery Group) and Control Group (Freehand Surgery Group). For all the patient in the study primary stability was assessed immediately after implant placement and secondary stability was assessed three months postoperatively. Postoperative pain was measured using the (VAS), immediately after surgery and one week later.

Interventions

PROCEDUREAll implant placements were performed exclusively in the maxillary region (upper jaw) to ensure a controlled comparison within the same anatomical area

All implant placements were performed exclusively in the maxillary region (upper jaw) to ensure a controlled comparison within the same anatomical area. The implants used in this study were C-Tech® implants (C-Tech Implant, Italy) with the following dimensions: Diameter: 3.8 mm Length: 11 mm . Cone-Beam Computed Tomography (CBCT): To assess bone quality, quantity, and anatomical structures . Digital Intraoral Scans Heron Scanner (USA) to obtain detailed gingival contours, occlusion, and existing teeth. The scan data was exported as an STL file for digital planning. Easy Check Implant Stability Measuring System is used for implant stability measurement, the tapping rod was gently placed in slight contact with the healing abutment, avoiding any axial or lateral pressure, and aligned within 0°-30° relative to the abutment's occlusal surface. If the angle exceeded 30°, the device issued an alert and prevented measurement, ensuring consistent alignment

Sponsors

University of Mosul
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Methods: randomized controlled clinical study included 30 patients with a total of 30 implants were placed and analyzed. All patients were randomly allocated into two groups: Test Group (Guided Surgery Group) and Control Group (Freehand Surgery Group). For all the patient in the study primary stability was assessed immediately after implant placement and secondary stability was assessed three months postoperatively. Postoperative pain was measured using the (VAS), immediately after surgery and one week later

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

The inclusion criteria for the study were: 1. Patients ≥18 years of age. 2. Presenting with maxillary tooth loss, 3. Tooth extraction at least 3 months before (delayed placement) 4. Adequate amount of bone volume to place the implant without bone augmentation (2 mm bone circumferentially around the implant). The

Exclusion criteria

for the study were: Patients were excluded from the study for the following reasons: 1. General contraindications to implant surgery; 2. Patients with history of chemo or radiotherapy; 3. Poor oral hygiene; 4. Pregnant or lactating women; 5. Uncontrolled diabetic patients.

Design outcomes

Primary

MeasureTime frameDescription
post operative painFrom placement of implant immediately and to the 2nd visit of treatment at one weekPostoperative pain was measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain), immediately after surgery and one week later
primary stability improvementFor all the patient in the study primary stability was assessed immediately after implant placementFor all the patient in the study primary stability was assessed postoperatively using ISQ. The Scale Implant Stability Quotient (ISQ) range between 1 to 100. The Interpretation of scores as follow: ISQ \>70: High stability ISQ 60-69: Moderate stability ISQ \<60: Low stability

Secondary

MeasureTime frameDescription
secondary stability outcome measureFor all the patient in the study, the secondary stability was assessed three months from implant placementthe secondary stability was assessed using ISQ. The Scale Implant Stability Quotient (ISQ) range between 1 to 100. The Interpretation of scores as follow: ISQ \>70: High stability ISQ 60-69: Moderate stability ISQ \<60: Low stability

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026