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

Not Applicable

Not yet recruiting

• Conditions: Partial Edentulism Class 1; Dental Implantation; Osseointegration

• Registration Number: NCT06764784
• Lead Sponsor: King Khalid University

Brief 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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01
• Primary Completion: 2025-01
• Study Completion: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Adults aged 18-80 years.
• Patients with partial edentulism (missing one or more teeth in an otherwise dentate arch).
• Sufficient bone volume and quality to support implant placement without additional bone augmentation.
• Good overall health with no systemic contraindications for surgery.
• Willingness to provide informed consent and comply with the study protocol and follow-up visits.

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Exclusion Criteria

• Patients with uncontrolled systemic conditions (e.g., diabetes, cardiovascular diseases) that may affect healing or surgery outcomes.
• Pregnant or lactating women.
• Smokers or individuals with a history of poor compliance with post-operative care.
• Patients requiring additional bone grafting, sinus lifts, or complex augmentation procedures for implant placement.
• Active oral infections, untreated periodontal disease, or severe malocclusion that could interfere with implant placement or outcomes.
• Patients with a history of bisphosphonate use or other medications known to affect bone metabolism.
• Individuals with mental or physical conditions that would impair their ability to participate in the study or follow the protocol.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Accuracy of Implant Placement	Immediately post-surgery	Accuracy of implant positioning will be assessed using postoperative radiographic imaging (CBCT) to measure deviations in angulation, depth, and position from the preoperative plan.
Postoperative Complication	Within 2 weeks post-surgery	Incidence of complications such as bleeding, infection, nerve damage, or soft tissue trauma will be recorded.

Secondary Outcome Measures

Name	Time	Method
Surgery Duration	During the surgical procedure	The time required for implant placement will be measured from the start of the surgery to the placement of the implant.
Pain Levels	Days 1, 3, and 7 post-surgery	Pain will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain).
Implant Stability	At 3, 6, and 12 months post-surgery	Resonance frequency analysis (RFA) will be used to measure the implant stability quotient (ISQ).