Clinical trial NCT06764784: The Efficacy of Freehand, Pilot Drilled and Fully Guided Implant Surgery in Partially Edentulous Patients: a Randomize Control Trial
Official title: The Efficacy of Freehand, Pilot Drilled and Fully Guided Implant Surgery in Partially Edentulous Patients: a Randomize Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Partial Edentulism Class 1
Dental Implantation
Osseointegration
Keywords: Partial edentulism
Dental implants
Freehand implant surgery
Pilot-drilled implant surgery
Fully guided implant surgery
Lead sponsor: King Khalid University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of Implant Placement
timeFrame: Immediately post-surgery
measure: Postoperative Complication
timeFrame: Within 2 weeks post-surgery
Secondary outcomes:
measure: Surgery Duration
timeFrame: During the surgical procedure
measure: Pain Levels
timeFrame: Days 1, 3, and 7 post-surgery
measure: Implant Stability
timeFrame: At 3, 6, and 12 months post-surgery
Other outcomes:
Locations:
Study officials:
References: