Dental Implant PlacementNCT07909278
Surgical Guide Versus Freehand Dental Implants Placement
A study testing Static Computer-Assisted Implant Surgery (CAIS) and Conventional Freehand Implant Placement in people with Dental Implant Placement, run by Khadyjah Ali Ali Alrassas at 1 site in Yemen.
Trial summary
This randomized clinical trial compares the accuracy of dental implant placement performed using a surgical guide with that achieved using the conventional freehand technique. Participants requiring dental implant placement are allocated to either guided implant placement or freehand implant placement. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dental Implant Placement
- What is being tested?
- Static Computer-Assisted Implant Surgery (CAIS) and Conventional Freehand Implant Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteYemen
- Study dates
- 15 Jul 2025to Mar 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Partially edentulous patients in need of one or more dental implants.
- Good overall health with no systemic conditions that impair healing.
- Absence of systemic diseases.
- Excellent oral hygiene.
- Patients over 18 years of age.
- Cooperative patients motivated to attend follow-up and maintenance visits.
- Patients who agree to sign an informed consent form.
Who cannot join
- Systemic conditions or pharmacological therapies that would render the intervention contraindicated (e.g., uncontrolled diabetes, immunocompromised states, treatment with oral or parenteral bisphosphonates, or osteoporosis).
- Poor oral hygiene.
- Heavy smokers (>10 cigarettes/day).
- Pregnant patients, patients under 18 years of age, and elderly patients over 65 years of age.
- Patients who are uncooperative or unable to attend scheduled follow-up visits.
- Patients requiring extensive bone grafting.
- Limited mouth opening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yemen1 site, 1 recruiting
- Recruiting
Faculty of dentistry sana'a university
Sanaa
Sam A Alrassas, PhD, +967 774 602 677, rassaskh23@gmail.com
Sam A Alrassas, PhD, rassaskh23@gmail.com
About this study
This randomized clinical trial compares the accuracy of dental implant placement performed using a surgical guide with that achieved using the conventional freehand technique. Participants requiring dental implant placement are allocated to either guided implant placement or freehand implant placement. The postoperative position of the implants is compared with the virtually planned implant position using three-dimensional image superimposition. The primary objective is to determine whether the use of a surgical guide improves the positional accuracy of dental implant placement compared with the freehand approach.
- Conditions
- Dental Implant Placement
- Being tested
- Static Computer-Assisted Implant Surgery (CAIS), Conventional Freehand Implant Placement
- Keywords
- Dental Implants, Guided Implant Surgery, Surgical Guide, Freehand Implant Placement, Implant Placement Accuracy, Computer-Guided Implant Surgery, CBCT Superimposition, Three-Dimensional Accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static Computer-Assisted Implant Surgery (CAIS)Procedure or surgery
Dental implants will be placed using a digitally planned, tooth-supported static surgical guide. Implant osteotomy preparation and implant insertion will be performed according to a fully guided surgical protocol.
Conventional Freehand Implant PlacementProcedure or surgery
Dental implants will be placed using a conventional freehand surgical approach following preoperative CBCT-based implant planning, without the use of a static surgical guide during implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Static Computer-Assisted Implant Surgery (CAIS) | Experimental | Participants assigned to this arm will undergo dental implant placement using a static computer-assisted implant surgery (CAIS) protocol with a digitally planned, tooth-supported surgical guide. Receives: Procedure: Static Computer-Assisted Implant Surgery (CAIS) |
| Conventional Freehand Implant Placement | Active comparator | Participants assigned to this arm will undergo conventional freehand dental implant placement following preoperative CBCT-based implant planning, without the use of a surgical guide during implant placement. Receives: Procedure: Conventional Freehand Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular Deviation of Dental Implant Placement
Angular deviation will be defined as the angle, expressed in degrees, between the longitudinal axes of the virtually planned and actually placed dental implants. The deviation will be determined by three-dimensional superimposition of the planned and postoperative implant positions.
Measured: 1 month after implant placement
Three-Dimensional Deviation at the Implant Apex (mm)
The three-dimensional linear distance between the virtually planned and actual postoperative implant apex positions will be measured following three-dimensional superimposition. The deviation will be expressed in millimeters (mm).
Measured: 1 month after implant placement
Three-Dimensional Deviation at the Implant Shoulder (mm)
The three-dimensional linear distance between the virtually planned and actual postoperative implant shoulder positions will be measured following three-dimensional superimposition. The deviation will be expressed in millimeters (mm).
Measured: 1 month after implant placement
Mesiodistal Deviation at the Implant Shoulder
The mesiodistal positional deviation at the implant shoulder will be measured in millimeters (mm) by comparing the virtually planned and actual postoperative implant positions using three-dimensional superimposition. Positive values indicate distal deviation, whereas negative values indicate mesial deviation.
Measured: 1 month after implant placement
Buccolingual Deviation at the Implant Shoulder
The buccolingual positional deviation at the implant shoulder will be measured in millimeters (mm) by comparing the virtually planned and actual postoperative implant positions using three-dimensional superimposition. Positive values indicate lingual deviation, whereas negative values indicate buccal deviation.
Measured: 1 month after implant placement
Apicocoronal Deviation at the Implant Shoulder
The apicocoronal positional deviation at the implant shoulder will be measured in millimeters (mm) by comparing the virtually planned and actual postoperative implant positions using three-dimensional superimposition. Positive values indicate apical deviation, whereas negative values indicate coronal deviation.
Measured: 1 month after implant placement
Mesiodistal Deviation at the Implant Apex
The mesiodistal positional deviation at the implant apex will be measured in millimeters (mm) by comparing the virtually planned and actual postoperative implant positions using three-dimensional superimposition. Positive values indicate distal deviation, whereas negative values indicate mesial deviation.
Measured: 1 month after implant placement
Buccolingual Deviation at the Implant Apex
The buccolingual positional deviation at the implant apex will be measured in millimeters (mm) by comparing the virtually planned and actual postoperative implant positions using three-dimensional superimposition. Positive values indicate lingual deviation, whereas negative values indicate buccal deviation.
Measured: 1 month after implant placement
Apicocoronal Deviation at the Implant Apex
The apicocoronal positional deviation at the implant apex will be measured in millimeters (mm) by comparing the virtually planned and actual postoperative implant positions using three-dimensional superimposition. Positive values indicate apical deviation, whereas negative values indicate coronal deviation.
Measured: 1 month 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 posted2 Nov 2026
- Study start15 Jul 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant PlacementStudies 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 assigned to one of two parallel groups: dental implant placement using a surgical guide or conventional freehand implant placement.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khadyjah Ali Ali Alrassas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Khadyjah Ali Ali Alrassas, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909278
- Sponsor's protocol ID
- OMFS:02/06/2025
- Status last verified
- Aug 2026
- First submitted
- 5 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because no formal data-sharing plan was included in the approved study protocol. Study findings will be reported in aggregate form while maintaining participant confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Guide Versus Freehand Dental Implants Placement
- ClinicalTrials.gov ID
- NCT07909278
- Acronym / sponsor ID
- OMFS:02/06/2025
- Conditions
- Dental Implant Placement
- Keywords
- Dental Implants, Guided Implant Surgery, Surgical Guide, Freehand Implant Placement, Implant Placement Accuracy, Computer-Guided Implant Surgery, CBCT Superimposition, Three-Dimensional Accuracy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Khadyjah Ali Ali AlrassasUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Nov 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 trial compares the accuracy of dental implant placement performed using a surgical guide with that achieved using the conventional freehand technique. Participants requiring dental implant placement are allocated to either guided implant placement or freehand implant placement. The postoperative position of the implants is compared with the virtually planned implant position using three-dimensional image superimposition. The primary objective is to determine whether the use of a surgical guide improves the positional accuracy of dental implant placement compared with the freehand approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: dental implant placement using a surgical guide or conventional freehand implant placement.
| Arm | Type | Receives |
|---|---|---|
| Static Computer-Assisted Implant Surgery (CAIS) | Experimental | Procedure: Static Computer-Assisted Implant Surgery (CAIS)Participants assigned to this arm will undergo dental implant placement using a static computer-assisted implant surgery (CAIS) protocol with a digitally planned, tooth-supported surgical guide. |
| Conventional Freehand Implant Placement | Active comparator | Procedure: Conventional Freehand Implant PlacementParticipants assigned to this arm will undergo conventional freehand dental implant placement following preoperative CBCT-based implant planning, without the use of a surgical guide during implant placement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Partially edentulous patients in need of one or more dental implants.
- Good overall health with no systemic conditions that impair healing.
- Absence of systemic diseases.
- Excellent oral hygiene.
- Patients over 18 years of age.
Key exclusion criteria (7 listed)
- Systemic conditions or pharmacological therapies that would render the intervention contraindicated (e.g., uncontrolled diabetes, immunocompromised states, treatment with oral or parenteral bisphosphonates, or osteoporosis).
- Poor oral hygiene.
- Heavy smokers (>10 cigarettes/day).
- Pregnant patients, patients under 18 years of age, and elderly patients over 65 years of age.
- Patients who are uncooperative or unable to attend scheduled follow-up visits.
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 |
|---|---|---|
| Static Computer-Assisted Implant Surgery (CAIS)Dental implants will be placed using a digitally planned, tooth-supported static surgical guide. Implant osteotomy preparation and implant insertion will be performed according to a fully guided surgical protocol. | Procedure or surgery | Static Computer-Assisted Implant Surgery (CAIS) |
| Conventional Freehand Implant PlacementDental implants will be placed using a conventional freehand surgical approach following preoperative CBCT-based implant planning, without the use of a static surgical guide during implant placement. | Procedure or surgery | Conventional Freehand Implant Placement |
Primary outcome
Angular Deviation of Dental Implant Placement
Time frame: 1 month after implant placement
Angular deviation will be defined as the angle, expressed in degrees, between the longitudinal axes of the virtually planned and actually placed dental implants. The deviation will be determined by three-dimensional superimposition of the planned and postoperative implant positions.
Three-Dimensional Deviation at the Implant Apex (mm)
Time frame: 1 month after implant placement
The three-dimensional linear distance between the virtually planned and actual postoperative implant apex positions will be measured following three-dimensional superimposition. The deviation will be expressed in millimeters (mm).
Three-Dimensional Deviation at the Implant Shoulder (mm)
Time frame: 1 month after implant placement
The three-dimensional linear distance between the virtually planned and actual postoperative implant shoulder positions will be measured following three-dimensional superimposition. The deviation will be expressed in millimeters (mm).
Mesiodistal Deviation at the Implant Shoulder
Time frame: 1 month after implant placement
The mesiodistal positional deviation at the implant shoulder will be measured in millimeters (mm) by comparing the virtually planned and actual postoperative implant positions using three-dimensional superimposition. Positive values indicate distal deviation, whereas negative values indicate mesial deviation.
Buccolingual Deviation at the Implant Shoulder
Time frame: 1 month after implant placement
The buccolingual positional deviation at the implant shoulder will be measured in millimeters (mm) by comparing the virtually planned and actual postoperative implant positions using three-dimensional superimposition. Positive values indicate lingual deviation, whereas negative values indicate buccal deviation.
Apicocoronal Deviation at the Implant Shoulder
Time frame: 1 month after implant placement
The apicocoronal positional deviation at the implant shoulder will be measured in millimeters (mm) by comparing the virtually planned and actual postoperative implant positions using three-dimensional superimposition. Positive values indicate apical deviation, whereas negative values indicate coronal deviation.
Mesiodistal Deviation at the Implant Apex
Time frame: 1 month after implant placement
The mesiodistal positional deviation at the implant apex will be measured in millimeters (mm) by comparing the virtually planned and actual postoperative implant positions using three-dimensional superimposition. Positive values indicate distal deviation, whereas negative values indicate mesial deviation.
Buccolingual Deviation at the Implant Apex
Time frame: 1 month after implant placement
The buccolingual positional deviation at the implant apex will be measured in millimeters (mm) by comparing the virtually planned and actual postoperative implant positions using three-dimensional superimposition. Positive values indicate lingual deviation, whereas negative values indicate buccal deviation.
Apicocoronal Deviation at the Implant Apex
Time frame: 1 month after implant placement
The apicocoronal positional deviation at the implant apex will be measured in millimeters (mm) by comparing the virtually planned and actual postoperative implant positions using three-dimensional superimposition. Positive values indicate apical deviation, whereas negative values indicate coronal deviation.
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 2 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because no formal data-sharing plan was included in the approved study protocol. Study findings will be reported in aggregate form while maintaining participant confidentiality and privacy.
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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 Static Computer-Assisted Implant Surgery (CAIS) and Conventional Freehand Implant Placement in people with Dental Implant Placement, run by Khadyjah Ali Ali Alrassas at 1 site in Yemen.
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 7 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: looking for participants now, as of the sponsor's last update on 2 Nov 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 Yemen. 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 Khadyjah A Alrassas, BDS (+967 774 602 677, rassaskh23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angular Deviation of Dental Implant Placement (time frame: 1 month after implant placement). The study lists 9 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 2 Nov 2026.