Partial Edentulism Class 1NCT06764784
The Efficacy of Freehand, Pilot Drilled and Fully Guided Implant Surgery in Partially Edentulous Patients: a Randomize Control Trial
A study testing Freehand Implant Surgery, Pilot-Drilled Implant Surgery and Fully Guided Implant Surgery in people with Partial Edentulism Class 1 and Dental Implantation, run by King Khalid University at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism Class 1, Dental Implantation, Osseointegration
- What is being tested?
- Freehand Implant Surgery, Pilot-Drilled Implant Surgery and Fully Guided Implant Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 6 Jan 2024to 6 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Freehand Implant Surgery, Pilot-Drilled Implant Surgery, Fully Guided Implant Surgery
- Keywords
- Partial edentulism, Dental implants, Freehand implant surgery, Pilot-drilled implant surgery, Fully guided implant surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freehand Implant SurgeryProcedure or 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.
Pilot-Drilled Implant SurgeryProcedure or 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.
Fully Guided Implant SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Procedure: Pilot-Drilled Implant Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately post-surgery
Postoperative Complication
Incidence of complications such as bleeding, infection, nerve damage, or soft tissue trauma will be recorded.
Measured: Within 2 weeks post-surgery
Secondary outcomes (3)
Surgery Duration
The time required for implant placement will be measured from the start of the surgery to the placement of the implant.
Measured: 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).
Measured: Days 1, 3, and 7 post-surgery
Implant Stability
Resonance frequency analysis (RFA) will be used to measure the implant stability quotient (ISQ).
Measured: At 3, 6, and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start6 Jan 2024
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Edentulism Class 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Khalid University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunil Kumar Vaddamanu, King Khalid University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764784
- Sponsor's protocol ID
- ECM#2024-3195
- Status last verified
- Dec 2025
- First submitted
- 2 Jan 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Freehand, Pilot Drilled and Fully Guided Implant Surgery in Partially Edentulous Patients: a Randomize Control Trial
- ClinicalTrials.gov ID
- NCT06764784
- Acronym / sponsor ID
- ECM#2024-3195
- Keywords
- Partial edentulism, Dental implants, Freehand implant surgery, Pilot-drilled implant surgery, Fully guided implant surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- King Khalid UniversityUniversity, hospital or other
- Study start
- 6 Jan 2024 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Freehand Implant Surgery | Experimental | Procedure: Freehand Implant SurgeryParticipants 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. |
| Pilot-Drilled Implant Surgery | Experimental | Procedure: Fully Guided Implant SurgeryParticipants 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. |
| Fully Guided Implant Surgery | Experimental | Procedure: Pilot-Drilled Implant SurgeryParticipants 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freehand Implant SurgeryThis 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. | Procedure or surgery | Freehand Implant Surgery |
| Pilot-Drilled Implant SurgeryThis 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. | Procedure or surgery | Fully Guided Implant Surgery |
| Fully Guided Implant SurgeryThis 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. | Procedure or surgery | Pilot-Drilled Implant Surgery |
Primary outcome
Accuracy of Implant Placement
Time frame: Immediately post-surgery
Accuracy of implant positioning will be assessed using postoperative radiographic imaging (CBCT) to measure deviations in angulation, depth, and position from the preoperative plan.
Postoperative Complication
Time frame: Within 2 weeks post-surgery
Incidence of complications such as bleeding, infection, nerve damage, or soft tissue trauma will be recorded.
3 secondary outcomes
Surgery Duration
Time frame: During the surgical procedure
Pain Levels
Time frame: Days 1, 3, and 7 post-surgery
Implant Stability
Time frame: At 3, 6, and 12 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freehand Implant Surgery, Pilot-Drilled Implant Surgery and Fully Guided Implant Surgery in people with Partial Edentulism Class 1 and Dental Implantation, run by King Khalid University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Implant Placement (time frame: Immediately post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.