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

NCT06764784 | Completed DMC

• 1 other identifier: ECM#2024-3195
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Partial Edentulism Class 1; Dental Implantation; Osseointegration

Keywords

Partial edentulism; Dental implants; Freehand implant surgery; Pilot-drilled implant surgery; Fully guided implant surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Surgery Duration

  During the surgical procedure

• Pain Levels

  Days 1, 3, and 7 post-surgery

• Implant Stability

  At 3, 6, and 12 months post-surgery

Study Arms (3)

Freehand Implant Surgery

EXPERIMENTAL

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

Pilot-Drilled Implant Surgery

EXPERIMENTAL

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

Fully Guided Implant Surgery

EXPERIMENTAL

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

Interventions

Pilot-Drilled Implant Surgery PROCEDURE

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.

Fully Guided Implant Surgery

Fully Guided Implant Surgery PROCEDURE

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.

Pilot-Drilled Implant Surgery

Freehand Implant Surgery PROCEDURE

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.

Freehand Implant Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Khalid University: lead

Study Sites (1)

King Khalid University

Abhā, Saudi Arabia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: January 6, 2024
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)