An interventional study of Freehand Implant Surgery and Pilot-Drilled Implant Surgery in Partial Edentulism Class 1, Dental Implantation and Osseointegration, sponsored by King Khalid University. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by King Khalid University · Not applicable, Interventional, and Treatment
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.
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.
King Khalid University is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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.
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.
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.
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.
Time frame: Immediately post-surgery
Postoperative Complication
Incidence of complications such as bleeding, infection, nerve damage, or soft tissue trauma will be recorded.
Time frame: Within 2 weeks post-surgery
Surgery Duration
The time required for implant placement will be measured from the start of the surgery to the placement of the implant.
Time frame: 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).
Time frame: Days 1, 3, and 7 post-surgery
Implant Stability
Resonance frequency analysis (RFA) will be used to measure the implant stability quotient (ISQ).
Time frame: At 3, 6, and 12 months post-surgery
Plan to share: No — 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.
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Feb 2024, 1 month.
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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King Khalid University