Edentulism in Lower JawNCT07863700
Accuracy of Immediate Implant Placement
A study testing Freehand Immediate Implant Placement, Tooth-Supported Static Computer-Guided Implant Placement and Tooth- and Socket-Supported Static Guided Implant Placement in people with Edentulism in Lower Jaw, run by Menoufia University at 1 site in Egypt.
Trial summary
This randomized clinical study will compare the accuracy of immediate implant placement performed using three different surgical approaches: freehand surgery, conventional tooth-supported static computer-guided surgery, and a tooth- and socket-supported static surgical guide. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulism in Lower Jaw
- What is being tested?
- Freehand Immediate Implant Placement, Tooth-Supported Static Computer-Guided Implant Placement and Tooth- and Socket-Supported Static Guided Implant Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 20-56 years.
- Patients requiring extraction of a mandibular first or second molar, or a retained root in the same region, followed by immediate implant placement.
- American Society of Anesthesiologists (ASA) Physical Status I or II.
- Satisfactory oral hygiene.
- Ability to comply with the scheduled follow-up protocol.
- Extraction socket classified as a Class I defect.
- Treatment site planned for rehabilitation with a single-unit screw-retained implant-supported crown.
- Adequate primary implant stability, defined as an insertion torque of ≥35 Ncm and/or an implant stability quotient (ISQ) of ≥60.
Who cannot join
- Uncontrolled systemic disease.
- Previous radiotherapy to the head and neck region.
- Active untreated periodontal disease.
- Heavy smoking of more than 10 cigarettes per day.
- Bisphosphonate therapy.
- Severe parafunctional habits such as bruxism.
Show all 10Show fewer
- Inability to achieve adequate primary stability, defined as an insertion torque <35 Ncm and an ISQ <60.
- Intraoperative detection of loss of the buccal cortical plate.
- Extraction socket defect exceeding Class I.
- Inability to complete the required follow-up protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Menoufia University
Shibīn al Kawm, Menoufia, 2266166
Mohammed A. El-Sawy, PhD, 00201061314522, mohamed.elsawy@dent.menofia.edu.eg
About this study
Official title: Accuracy of Immediate Implant Placement Using Freehand and Different Static Surgical Guide Designs
This randomized clinical study will compare the accuracy of immediate implant placement performed using three different surgical approaches: freehand surgery, conventional tooth-supported static computer-guided surgery, and a tooth- and socket-supported static surgical guide.
Patients requiring extraction of a mandibular first or second molar, or a retained root in the same region, followed by immediate implant placement will be enrolled. All participants will undergo three-dimensional preoperative treatment planning using cone-beam computed tomography and intraoral scanning. Participants will then be randomly allocated to one of three groups according to the assigned surgical technique.
Read more
The primary outcome will be the three-dimensional accuracy of implant placement, determined by comparing the virtually planned implant position with the clinically achieved implant position. Coronal, apical, angular, and depth deviations will be evaluated using postoperative three-dimensional imaging.
The study will determine whether the use of conventional tooth-supported or tooth- and socket-supported static surgical guides results in different implant positioning accuracy compared with freehand immediate implant placement.
Read the detailed description
Immediate implant placement can reduce treatment time and the number of surgical interventions; however, accurate three-dimensional implant positioning can be challenging because the anatomy of the extraction socket does not necessarily correspond to the ideal prosthetically driven implant position. Static computer-guided implant surgery allows the virtually planned implant position to be transferred to the surgical field, but its accuracy may be influenced by the design and stability of the surgical guide.
This randomized clinical study will compare the accuracy of immediate implant placement using three surgical approaches: freehand surgery, conventional tooth-supported static computer-guided surgery, and a tooth- and socket-supported static surgical guide.
Patients aged 20-56 years requiring extraction of a mandibular first or second molar, or a retained root in the same region, followed by immediate implant placement will be considered for enrollment. Eligible participants will be classified as American Society of Anesthesiologists Physical Status I or II, have satisfactory oral hygiene, and be able to comply with the scheduled follow-up protocol. Only Class I extraction sockets planned for rehabilitation with a single-unit screw-retained implant-supported crown will be included.
Participants will undergo standardized preoperative digital assessment, including cone-beam computed tomography and intraoral scanning. The ideal implant position, angulation, depth, and dimensions will be virtually planned according to the available anatomy and intended prosthetic restoration. Participants will then be randomly allocated to one of three groups.
Group 1 will receive immediate implant placement using a freehand surgical approach without a surgical guide. Group 2 will receive immediate implant placement using a conventional tooth-supported static surgical guide fabricated according to the virtual implant plan. Group 3 will receive immediate implant placement using a tooth- and socket-supported static surgical guide designed to obtain stabilization from both the remaining dentition and the extraction socket.
All surgical procedures will be performed by a single experienced clinician under local anesthesia. Atraumatic extraction will be performed with preservation of the extraction socket walls, particularly the buccal cortical plate, and routine flap elevation will be avoided. The implants will be placed according to the allocated surgical protocol and the manufacturer's recommended surgical procedure. Insertion torque and implant stability quotient will be recorded immediately after implant placement.
The primary outcome will be three-dimensional implant placement accuracy. Following implant placement, postoperative cone-beam computed tomography will be obtained and registered with the corresponding preoperative virtual treatment plan. The clinically achieved implant position will be compared with the planned position.
Accuracy will be assessed using coronal deviation, defined as the three-dimensional linear distance between the planned and actual implant positions at the implant platform; apical deviation, defined as the three-dimensional linear distance between the planned and actual implant positions at the implant apex; angular deviation, defined as the three-dimensional angular difference between the longitudinal axes of the planned and clinically placed implants; and depth deviation, defined as the difference in the apicocoronal position between the planned and clinically achieved implant positions.
The study will test the null hypothesis that there are no significant differences in implant positioning accuracy among immediate implant placement performed using freehand surgery, conventional tooth-supported static surgical guides, and tooth- and socket-supported static surgical guides.
- Conditions
- Edentulism in Lower Jaw
- Being tested
- Freehand Immediate Implant Placement, Tooth-Supported Static Computer-Guided Implant Placement, Tooth- and Socket-Supported Static Guided Implant Placement
- Keywords
- Immediate implant placement, implant placement accuracy, computer-guided implant surgery, implant positional accuracy, mandibular molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freehand Immediate Implant PlacementProcedure or surgery
Immediate implant placement performed using a freehand surgical approach without a surgical guide.
Tooth-Supported Static Computer-Guided Implant PlacementProcedure or surgery
Immediate implant placement performed using a conventional tooth-supported static surgical guide fabricated according to the virtual implant plan.
Tooth- and Socket-Supported Static Guided Implant PlacementProcedure or surgery
Immediate implant placement performed using a tooth- and socket-supported static surgical guide designed to obtain stabilization from both the remaining dentition and the extraction socket.
| Study group | Role | What they receive |
|---|---|---|
| Freehand Immediate Implant Placement | Experimental | Participants assigned to this arm will undergo immediate implant placement using a freehand surgical approach without a surgical guide. The virtually planned implant position will be available as a reference, but no surgical guide will be used during osteotomy preparation or implant insertion. Receives: Procedure: Freehand Immediate Implant Placement |
| Tooth-Supported Static Surgical Guide | Experimental | Participants assigned to this arm will undergo immediate implant placement using a conventional tooth-supported static surgical guide fabricated according to the finalized virtual implant plan. The guide will be seated and its stability verified before guided osteotomy preparation and implant placement. Receives: Procedure: Tooth-Supported Static Computer-Guided Implant Placement |
| Tooth- and Socket-Supported Static Surgical Guide | Experimental | Participants assigned to this arm will undergo immediate implant placement using a tooth- and socket-supported static surgical guide designed to obtain stabilization from both the remaining dentition and the extraction socket. Proper seating and stability will be confirmed before guided osteotomy preparation and implant placement. Receives: Procedure: Tooth- and Socket-Supported Static Guided Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-dimensional implant placement accuracy
Three-dimensional implant placement accuracy will be assessed by comparing the clinically achieved implant position with the preoperatively planned virtual implant position using postoperative cone-beam computed tomography (CBCT) and three-dimensional registration. Accuracy will be evaluated by measuring coronal deviation, apical deviation, angular deviation, and depth deviation between the planned and clinically achieved implant positions.
Measured: Immediately after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulism in Lower JawStudies 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
- Model description
- Participants will be randomly allocated in a parallel-group design to one of three immediate implant placement approaches: freehand surgery, conventional tooth-supported static computer-guided surgery, or tooth- and socket-supported static surgical guide surgery. Each participant will receive the assigned intervention only.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863700
- Sponsor's protocol ID
- ADMNF-120926
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Up on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Immediate Implant Placement Using Freehand and Different Static Surgical Guide Designs
- ClinicalTrials.gov ID
- NCT07863700
- Acronym / sponsor ID
- ADMNF-120926
- Conditions
- Edentulism in Lower Jaw
- Keywords
- Immediate implant placement, implant placement accuracy, computer-guided implant surgery, implant positional accuracy, mandibular molar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 7 Oct 2026 (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 randomized clinical study will compare the accuracy of immediate implant placement performed using three different surgical approaches: freehand surgery, conventional tooth-supported static computer-guided surgery, and a tooth- and socket-supported static surgical guide.
Patients requiring extraction of a mandibular first or second molar, or a retained root in the same region, followed by immediate implant placement will be enrolled. All participants will undergo three-dimensional preoperative treatment planning using cone-beam computed tomography and intraoral scanning. Participants will then be randomly allocated to one of three groups according to the assigned surgical technique.
The primary outcome will be the three-dimensional accuracy of implant placement, determined by comparing the virtually planned implant position with the clinically achieved implant position. Coronal, apical, angular, and depth deviations will be evaluated using postoperative three-dimensional imaging.
The study will determine whether the use of conventional tooth-supported or tooth- and socket-supported static surgical guides results in different implant positioning accuracy compared with freehand immediate implant placement.
Detailed description
Immediate implant placement can reduce treatment time and the number of surgical interventions; however, accurate three-dimensional implant positioning can be challenging because the anatomy of the extraction socket does not necessarily correspond to the ideal prosthetically driven implant position. Static computer-guided implant surgery allows the virtually planned implant position to be transferred to the surgical field, but its accuracy may be influenced by the design and stability of the surgical guide.
This randomized clinical study will compare the accuracy of immediate implant placement using three surgical approaches: freehand surgery, conventional tooth-supported static computer-guided surgery, and a tooth- and socket-supported static surgical guide.
Patients aged 20-56 years requiring extraction of a mandibular first or second molar, or a retained root in the same region, followed by immediate implant placement will be considered for enrollment. Eligible participants will be classified as American Society of Anesthesiologists Physical Status I or II, have satisfactory oral hygiene, and be able to comply with the scheduled follow-up protocol. Only Class I extraction sockets planned for rehabilitation with a single-unit screw-retained implant-supported crown will be included.
Participants will undergo standardized preoperative digital assessment, including cone-beam computed tomography and intraoral scanning. The ideal implant position, angulation, depth, and dimensions will be virtually planned according to the available anatomy and intended prosthetic restoration. Participants will then be randomly allocated to one of three groups.
Group 1 will receive immediate implant placement using a freehand surgical approach without a surgical guide. Group 2 will receive immediate implant placement using a conventional tooth-supported static surgical guide fabricated according to the virtual implant plan. Group 3 will receive immediate implant placement using a tooth- and socket-supported static surgical guide designed to obtain stabilization from both the remaining dentition and the extraction socket.
All surgical procedures will be performed by a single experienced clinician under local anesthesia. Atraumatic extraction will be performed with preservation of the extraction socket walls, particularly the buccal cortical plate, and routine flap elevation will be avoided. The implants will be placed according to the allocated surgical protocol and the manufacturer's recommended surgical procedure. Insertion torque and implant stability quotient will be recorded immediately after implant placement.
The primary outcome will be three-dimensional implant placement accuracy. Following implant placement, postoperative cone-beam computed tomography will be obtained and registered with the corresponding preoperative virtual treatment plan. The clinically achieved implant position will be compared with the planned position.
Accuracy will be assessed using coronal deviation, defined as the three-dimensional linear distance between the planned and actual implant positions at the implant platform; apical deviation, defined as the three-dimensional linear distance between the planned and actual implant positions at the implant apex; angular deviation, defined as the three-dimensional angular difference between the longitudinal axes of the planned and clinically placed implants; and depth deviation, defined as the difference in the apicocoronal position between the planned and clinically achieved implant positions.
The study will test the null hypothesis that there are no significant differences in implant positioning accuracy among immediate implant placement performed using freehand surgery, conventional tooth-supported static surgical guides, and tooth- and socket-supported static surgical guides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly allocated in a parallel-group design to one of three immediate implant placement approaches: freehand surgery, conventional tooth-supported static computer-guided surgery, or tooth- and socket-supported static surgical guide surgery. Each participant will receive the assigned intervention only.
| Arm | Type | Receives |
|---|---|---|
| Freehand Immediate Implant Placement | Experimental | Procedure: Freehand Immediate Implant PlacementParticipants assigned to this arm will undergo immediate implant placement using a freehand surgical approach without a surgical guide. The virtually planned implant position will be available as a reference, but no surgical guide will be used during osteotomy preparation or implant insertion. |
| Tooth-Supported Static Surgical Guide | Experimental | Procedure: Tooth-Supported Static Computer-Guided Implant PlacementParticipants assigned to this arm will undergo immediate implant placement using a conventional tooth-supported static surgical guide fabricated according to the finalized virtual implant plan. The guide will be seated and its stability verified before guided osteotomy preparation and implant placement. |
| Tooth- and Socket-Supported Static Surgical Guide | Experimental | Procedure: Tooth- and Socket-Supported Static Guided Implant PlacementParticipants assigned to this arm will undergo immediate implant placement using a tooth- and socket-supported static surgical guide designed to obtain stabilization from both the remaining dentition and the extraction socket. Proper seating and stability will be confirmed before guided osteotomy preparation and implant placement. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients aged 20-56 years.
- Patients requiring extraction of a mandibular first or second molar, or a retained root in the same region, followed by immediate implant placement.
- American Society of Anesthesiologists (ASA) Physical Status I or II.
- Satisfactory oral hygiene.
- Ability to comply with the scheduled follow-up protocol.
Key exclusion criteria (10 listed)
- Uncontrolled systemic disease.
- Previous radiotherapy to the head and neck region.
- Active untreated periodontal disease.
- Heavy smoking of more than 10 cigarettes per day.
- Bisphosphonate therapy.
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 Immediate Implant PlacementImmediate implant placement performed using a freehand surgical approach without a surgical guide. | Procedure or surgery | Freehand Immediate Implant Placement |
| Tooth-Supported Static Computer-Guided Implant PlacementImmediate implant placement performed using a conventional tooth-supported static surgical guide fabricated according to the virtual implant plan. | Procedure or surgery | Tooth-Supported Static Surgical Guide |
| Tooth- and Socket-Supported Static Guided Implant PlacementImmediate implant placement performed using a tooth- and socket-supported static surgical guide designed to obtain stabilization from both the remaining dentition and the extraction socket. | Procedure or surgery | Tooth- and Socket-Supported Static Surgical Guide |
Primary outcome
Three-dimensional implant placement accuracy
Time frame: Immediately after implant placement
Three-dimensional implant placement accuracy will be assessed by comparing the clinically achieved implant position with the preoperatively planned virtual implant position using postoperative cone-beam computed tomography (CBCT) and three-dimensional registration. Accuracy will be evaluated by measuring coronal deviation, apical deviation, angular deviation, and depth deviation between the planned and clinically achieved implant positions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. Up on reasonable request.
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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.
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 Immediate Implant Placement, Tooth-Supported Static Computer-Guided Implant Placement and Tooth- and Socket-Supported Static Guided Implant Placement in people with Edentulism in Lower Jaw, run by Menoufia University at 1 site in Egypt.
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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 13 Oct 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed A. El-Sawy, PhD (00201061314522, mohamed.elsawy@dent.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-dimensional implant placement accuracy (time frame: Immediately after implant placement). 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 13 Oct 2026.