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

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.

Study Overview

• Status: Completed
• Conditions: Dental Implantation; Osseointegration; Partial Edentulism Class 1
• Intervention / Treatment: Procedure: Freehand Implant Surgery; Procedure: Fully Guided Implant Surgery; Procedure: Pilot-Drilled Implant Surgery

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Abhā, Saudi Arabia
    • King Khalid University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Freehand Implant Surgery; Participants in this arm will undergo implant placement using the freehand technique. This approach relies on the surgeon's clinical judgment and visual landmarks for implant positioning without the use of specialized guides.	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.
Experimental: Pilot-Drilled Implant Surgery; Participants in this arm will undergo implant placement using the pilot-drilled technique. A pilot drill will be used to create an initial guided pathway for the implant, improving placement accuracy while allowing for some flexibility during the procedure.	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.
Experimental: Fully Guided Implant Surgery; Participants in this arm will undergo implant placement using the fully guided technique. This approach utilizes computer-aided surgical templates created from preoperative imaging to ensure precise implant 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: King Khalid University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2024
• Primary Completion (Actual): February 6, 2024
• Study Completion (Actual): February 6, 2024

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): January 8, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Dental implants; Partial edentulism; Freehand implant surgery; Pilot-drilled implant surgery; Fully guided implant surgery
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: ECM#2024-3195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data (IPD) will not be shared due to concerns related to patient privacy and confidentiality. Although the study will follow rigorous data collection and management protocols, sharing raw participant data might compromise the anonymity and security of the participants' health information. Additionally, the data may be specific to the study design and not directly generalizable, limiting its applicability to external research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No