NCT06764784

The Efficacy of Freehand, Pilot Drilled and Fully Guided Implant Surgery in Partially Edentulous Patients: a Randomize Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: King Khalid University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study evaluates three different methods of dental implant surgery-freehand, pilot-drilled, and fully guided techniques-in patients with partial tooth loss (partial edentulism). Dental implants are widely used to restore missing teeth, but the success of these procedures depends heavily on accurate placement and surgical precision. The study involves 90 participants, divided into three groups of 30, each undergoing one of the three surgical techniques. The main goals are to compare surgery duration, implant placement accuracy, post-operative recovery, patient satisfaction, and long-term success rates. Key findings suggest that fully guided implant surgery offers the highest accuracy, the shortest recovery time, and the highest patient satisfaction. Pilot-drilled surgery also showed excellent results, providing a balance between precision and efficiency. Freehand surgery, while flexible, showed slightly lower accuracy and higher complication rates. This research aims to guide patients and healthcare providers in selecting the most suitable implant surgery method for improved outcomes and long-term success in dental care.

Detailed description

This randomized controlled trial will investigate the efficacy of three implant placement techniques-freehand, pilot-drilled, and fully guided-in patients with partial tooth loss. The study will explore critical factors such as surgical precision, patient recovery, implant stability, and overall satisfaction. The objective will be to provide evidence-based guidance for selecting optimal surgical techniques tailored to individual patient needs. Study Design: Participants: 90 partially edentulous patients will be randomly assigned into three groups (30 patients per group). Techniques: Freehand surgery: Surgeons will rely on their skill and judgment for implant placement without specialized guides. Pilot-drilled surgery: Surgeons will use a pilot drill to create an initial guided pathway for implant placement. Fully guided surgery: Computer-aided templates will be utilized for precise positioning based on preoperative imaging and planning. Outcomes Measured: Surgical Parameters: Duration of surgery. Intraoperative complications. Postoperative Recovery: Pain, swelling, and healing responses. Implant Stability and Osseointegration: Radiographic imaging and resonance frequency analysis will assess outcomes at 3, 6, and 12 months. Patient Satisfaction: Surveys will measure aesthetics, comfort, and satisfaction with treatment outcomes. Long-term Success Rates: Implant survival rates and peri-implant bone health will be evaluated. Key Findings: Fully guided surgery is expected to demonstrate superior accuracy, reduced recovery times, and the highest patient satisfaction. Pilot-drilled surgery is anticipated to offer a robust balance of precision and efficiency, with high implant survival rates. Freehand surgery may show slightly lower success rates and higher variability in outcomes.

Conditions

• Partial Edentulism Class 1
• Dental Implantation
• Osseointegration

Interventions

Type	Name	Description
PROCEDURE	Freehand Implant Surgery	This intervention involves implant placement performed manually by the surgeon without the use of specialized guides. The procedure relies on the surgeon's clinical judgment and experience to determine the implant's positioning, angulation, and depth.
PROCEDURE	Pilot-Drilled Implant Surgery	This intervention utilizes a pilot drill to create an initial guide hole for the implant. The pilot-drilled pathway improves accuracy while still allowing the surgeon flexibility during the procedure. The final implant is placed following sequential drilling.
PROCEDURE	Fully Guided Implant Surgery	This intervention employs computer-aided surgical templates created from preoperative imaging data, such as CBCT scans. These guides ensure precise implant positioning, angulation, and depth based on preoperative planning. The approach minimizes variability and enhances accuracy.

Timeline

• Start date: 2024-01-06
• Primary completion: 2024-02-06
• Completion: 2024-02-06
• First posted: 2025-01-08
• Last updated: 2026-01-06

Locations

1 site across 1 country: Saudi Arabia