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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06764784
Enrollment
90
Registered
2025-01-08
Start date
2024-01-06
Completion date
2024-02-06
Last updated
2026-01-06

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

Conditions

Dental Implantation, Osseointegration, Partial Edentulism Class 1

Keywords

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

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.

Interventions

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.

PROCEDUREPilot-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.

PROCEDUREFully 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.

Sponsors

King Khalid University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of Implant PlacementImmediately post-surgeryAccuracy of implant positioning will be assessed using postoperative radiographic imaging (CBCT) to measure deviations in angulation, depth, and position from the preoperative plan.
Postoperative ComplicationWithin 2 weeks post-surgeryIncidence of complications such as bleeding, infection, nerve damage, or soft tissue trauma will be recorded.

Secondary

MeasureTime frameDescription
Surgery DurationDuring the surgical procedureThe time required for implant placement will be measured from the start of the surgery to the placement of the implant.
Pain LevelsDays 1, 3, and 7 post-surgeryPain will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain).
Implant StabilityAt 3, 6, and 12 months post-surgeryResonance frequency analysis (RFA) will be used to measure the implant stability quotient (ISQ).

Countries

Saudi Arabia

Outcome results

None listed

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